Detect cancer early, when it can be cured.

Next-Generation Foundational Research Use Only (RUO) Targeted Methylation-Based Solution for Post-Diagnosis Applications and Biomarker Discovery Can be Enhanced With Custom Classifier Development    MENLO PARK, Calif., Jan. 9, 2023 – GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced the availability of a state-of-the-art research use only offering for biopharmaceutical companies. The new technology solution uses GRAIL’s proprietary targeted methylation platform to analyze cell-free DNA (cfDNA) isolated from peripheral blood for cancer signal interrogation. Potential research use cases include, but are not limited to, prognosis, minimal residual disease detection, and recurrence monitoring across different cancer types in research studies. “GRAIL’s unique methylation technology and bioinformatics capabilities are well suited for circulating tumor DNA analysis across the cancer continuum,” said Bob Ragusa, Chief Executive Officer at GRAIL. “We are excited to further leverage our methylation platform and introduce our RUO technology solution for cancer prognosis, minimal residual disease and recurrence monitoring and biomarker discovery. The new technology solution has the versatility to be used in solid tumor research and can be customized to improve performance in specific use cases, including custom classifier development.” GRAIL’s RUO technology solution estimates tumor burden based on methyl variant allele fraction (MVAF), enabling longitudinal monitoring and surveillance solutions. Data from GRAIL studies have demonstrated analytically validated performance, and robust analytical sensitivity, specificity, and precision. The blood-only liquid biopsy approach eliminates challenges with obtaining tissue samples and avoids bias due to tumor heterogeneity or tumor escape mechanisms. The low input requirements support retrospective research studies. Several biopharmaceutical partners have leveraged early access to the RUO technology solution, which is now broadly available. For more information, please visit www.GRAIL.com.  ### About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission. For more information, visit grail.com. Laboratory/Test Information GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The RUO test was developed, and its performance characteristics were determined by GRAIL. The RUO test is For Research Use Only, Not for Diagnostic Purposes. GRAIL's current product offerings have not been cleared or approved by the Food and Drug Administration.

 The new PGA TOUR Champions event will direct a portion of proceeds from its inaugural tournament to the American Cancer Society (Palm Desert office), Desert Cancer Foundation, Eisenhower Health, Hanson House, Pendleton Foundation and Shay’s Warriors Life After Cancer; All ticket offerings for The Galleri Classic are now available at www.thegallericlassic.com.   RANCHO MIRAGE, CALIF. – For the first time in 30 years, The Galleri® Classic will bring the PGA TOUR Champions golf tournament back to the Coachella Valley. Proceeds from The Galleri Classic will fund local and cancer-related non-profit organizations focused on underserved populations. The Galleri Classic is pleased to announce the following six charitable partners: American Cancer Society (Palm Desert office), Desert Cancer Foundation, Eisenhower Health, Hanson House, Pendleton Foundation and Shay’s Warriors Life After Cancer. The Galleri® Classic, named after GRAIL’s multi-cancer early detection test, debuts March 24-26, 2023 on the Dinah Shore Tournament Course at the renowned Mission Hills Country Club. The tournament will feature 78 PGA TOUR Champions professionals, including World Golf Hall of Fame members, playing 54 holes (three rounds) of stroke play for a $2.2 million purse. "GRAIL and the PGA TOUR share a commitment to positively impacting the lives of people and communities that we touch, and we are thrilled to work together to increase awareness for multi-cancer early detection and to raise proceeds in support of local cancer-related causes," said Bob Ragusa, Chief Executive Officer of GRAIL. "As the title sponsor of The Galleri® Classic, GRAIL has chosen to partner with several Coachella Valley nonprofits with a proven track record of engaging local, underserved populations in cancer education, risk reduction, and access to treatment and supportive care." The American Cancer Society’s Palm Desert office is one of over 5,000 branches nationwide representing the nation’s leading nonprofit organization with a mission of providing support and improving the lives of cancer patients and their families through advocacy, research, and patient support, to ensure everyone has an opportunity to prevent, detect, treat, and survive cancer. The American Cancer Society (ACS) has developed a program, in partnership with community health systems across the country, to help increase cancer screening rates in underserved areas. It engages with these health system partners to assess current screening barriers and create customized strategies to overcome these barriers. Charitable funds from The Galleri® Classic will be used to support the ACS “Get Screened California” effort and will enable a new community health system in the Coachella Valley to participate in this program and increase cancer screening rates for the valley’s underserved population. Desert Cancer Foundation was founded in 1994 to pay for cancer treatment of residents who lack health insurance or sufficient funds to pay for their medical care. The foundation works with the generous support of local healthcare professionals, social workers, case workers, and advocates to share the availability of its program with the community. Since its inception, Desert Cancer Foundation has served more than 8,250 residents in the Coachella Valley and surrounding communities and has paid for cancer-related screenings, diagnostics, and treatments valued at nearly $100 million dollars. Eisenhower Health is a comprehensive health care institution in Rancho Mirage that includes the 437-bed Eisenhower Hospital, the Barbara Sinatra Children’s Center at Eisenhower and the Annenberg Center for Health Sciences at Eisenhower. Eisenhower is renowned for its Centers of Excellence in Orthopedics, Cardiovascular, Neuroscience and Oncology and has provided a full range of quality medical and educational services for 50 years for residents and visitors within the greater Coachella Valley. Eisenhower has twice earned ANCC Magnet Recognition® for professionalism in nursing and excellence in patient care. Hanson House provides low- or no-cost housing and serves as a “home away from home” for the loved ones of critically ill and injured, hospitalized patients who lack financial resources. Such individuals include cancer patients receiving chemotherapy and radiation treatment. Situated next to Palm Springs’ Desert Regional Medical Center, Hanson House serves more than 1,000 family members each year, which also includes parents of newborn babies critically ill in the Neonatal Intensive Care Unit (NICU), military families from the Marine Base at 29 Palms and all families of First Responders. The Pendleton Foundation was set up to assist Coachella Valley families who are dealing with all cancers, and it supports families in their decisions regarding treatment by providing financial assistance, according to its bylaws, to ease the financial impact upon their households. The inspiration for the creation of the foundation was born from the personal experiences of Karen Pendleton, who was diagnosed with Pseudomyxoma peritonei, a highly aggressive form of colon cancer, and discovered the great need for financial and emotional support while going through the process of seeking and receiving treatment. Shay’s Warriors Life After Cancer was initially formed in the Coachella Valley to help women who have gone through breast, and other reproductive, cancers and has since expanded its mission to help all cancer survivors. Shay’s Warriors organizes ongoing educational programs, workshops, and special events with the mission of inspiring, informing, empowering, and helping heal cancer survivors and their families through health, fitness, and the mind-body connection. “The Galleri Classic chooses to join in on the broader fight against cancer, and we set this foundation towards creating a lasting legacy of giving back to our Coachella Valley communities and serving to take care of our local citizens most in need,” said Michelle DeLancy, tournament director of The Galleri Classic. “Everyone knows someone who has been victimized by this dreaded disease and we plan to be diligent in making a difference in the desert by aligning with, and financially aiding, our charitable partners who are successfully executing their worthy causes.” Part of The Galleri Classic’s donations will be funded through its ticket sales, which is now active online at its official website, www.thegallericlassic.com. Golf and sports fans can play a part in supporting the tournament’s off-course charitable endeavor by securing daily and weekly grounds and clubhouse tickets – including a current holiday ticket special (through Jan. 1) of $5 off the regular price of single-day grounds admission. Those interested in volunteering or securing limited remaining playing spots in The Galleri Classic Pro-Am (March 22-23) can visit www.thegallericlassic.com to submit a digital form of inquiry to learn more. Tournament patrons ordering tickets at the event website also hold the option of making a flat donation to any of The Galleri Classic’s six charitable beneficiaries during the online checkout process. Stay up to date with the latest information on The Galleri Classic by visiting www.thegallericlassic.com and by following the tournament on Facebook (https://www.facebook.com/gallericlassic), Instagram (@GalleriClassic) and Twitter (@GalleriClassic).   ###   About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission. For more information, please visit grail.com. About Galleri® The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi- cancer early detection test can detect cancer signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed health care provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older. For more information about Galleri, visit galleri.com. About PGA TOUR Champions PGA TOUR Champions is a membership organization of professional golfers age 50 and older, including 34 members of the World Golf Hall of Fame. The Tour’s mission is to provide financial opportunities for its players, entertain and inspire its fans, deliver substantial value to its partners, create outlets for volunteers to give back and generate significant charitable and economic impact in tournament communities. Follow PGA TOUR Champions online at PGATOUR.com, at facebook.com/PGATOURChampions, on Twitter @ChampionsTour, on Instagram @pgatourchampions and on TikTok (pgatourchampions). All events are televised in the United States, with most receiving complete coverage on GOLF Channel, the exclusive cable-television partner of PGA TOUR Champions. Tournament programming is available via 20-plus TV linear partners in 170-plus countries and territories, with 25 channels carrying long-form and/or highlights coverage, and 170-plus hours of live coverage distributed in 130-plus countries and territories. Programming is also available via the OTT platform GOLFTV powered by PGA TOUR in every market outside of the United States (240-plus countries and territories), excluding China, Korea and Russia, with live coverage distributed in 130-plus countries and territories.

Canton, Mass. and Menlo Park, Calif., Dec. 15, 2022 — Point32Health, the parent company of Harvard Pilgrim Health Care, and GRAIL, LLC, a health care company with a mission of detecting cancer early when it can be cured, today announced the expansion of their pilot to offer GRAIL’s groundbreaking Galleri® multi-cancer early detection blood test to Harvard Pilgrim members at no cost who purchase their insurance on the Maine Health Insurance Marketplace. This expansion is the second phase of a pilot focused on collecting real-world evidence to assess the impact of the Galleri test on health care resource utilization and patient-reported outcomes. “We are proud to be an industry leader in bringing cutting-edge, innovative technologies and services to our members,” said Cain A. Hayes, president and CEO at Point32Health. “We are thrilled to expand our pilot of this game-changing screening tool to a subset of our members in Maine. This test has the potential to change the lives of countless people and their families impacted by cancer.” Harvard Pilgrim Health Care HMO members on Maine’s insurance marketplace can participate in the second phase of this pilot. Eligible members will be mailed information for how to participate in the pilot. Point32Health is the first commercial health plan in the U.S. to work with GRAIL to offer its Galleri® test as a complement to recommended cancer screenings. The first phase of the pilot launched earlier this year when Point32Health made the test available at no cost to eligible employees. “We know that cancer has a critical impact in Maine, with one in three Mainers facing a cancer diagnosis in their lifetime,” said Bill Whitmore, vice president for the Maine market at Harvard Pilgrim Health Care.  “This pilot will help facilitate early detection when treatment can be more effective and there is the potential for a cure.” According to the Maine Cancer Foundation, cancer is the leading cause of death in Maine. The pilot’s expansion to Maine is an opportunity to help people living in an area where cancer rates are significantly higher than the national average. Harvard Pilgrim Health Care recently provided a matching grant to the Maine Cancer Foundation to launch the Maine Cancer Blueprint to help better understand the current state of cancer in Maine. “Multi-cancer early detection tests, like Galleri, are the future because of their ability to find more cancers earlier, before symptoms appear, with a single blood test,” said Josh Ofman, MD, MSHS, president at GRAIL. “We are delighted to expand our pilot with Point32Health, the first commercial health plan in the U.S. to offer Galleri, following successful implementation of the initial pilot phase with their eligible employees. We believe offering Galleri can help increase early cancer detection in Maine, where cancer rates are significantly higher than the national average.” In a clinical study, the Galleri test demonstrated the ability to detect a shared cancer signal across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, over 45 of which lack recommended screening tests today, with a low false positive rate of less than 1 percent. When cancer is detected, Galleri can determine the cancer signal origin with high accuracy. More than 600,000 people died from cancer last year in the United States, according to the American Cancer Society. This is in large part because the majority of cancers are found too late when outcomes are often poor. Recommended screening tests save lives, but only cover five cancer types in the U.S.: breast, colon, cervical, prostate, and (in high-risk adults) lung. In fact, about seven in 10 cancer deaths are from cancers that lack recommended early detection screening. ###About Point32Health Point32Health is a leading health and wellbeing organization, delivering an ever-better health care experience to everyone in our communities. Building on the quality, nonprofit heritage of our founding organizations, Tufts Health Plan and Harvard Pilgrim Health Care, we leverage our experience and expertise to help people find their version of healthier living through a broad range of health plans and tools that make navigating health and wellbeing easier. Our programs take a 360-degree view of health for our members—no matter their age, health, race, identity or income. Our Institute works to improve population health—and our Foundation works with communities to support, advocate and advance healthier lives for everyone. We use empathy to understand what’s important to those we serve, always making their priorities our own. And we work to guide and empower people by bringing together wide-ranging partners and perspectives to create new approaches that make a real difference for our community, our industry and our 2.2 million members across New England. About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission. For more information, visit grail.com. About Galleri® The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect a shared cancer signal across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed health care provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older. For more information about Galleri, visit galleri.com. Important Galleri Safety Information The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “Cancer Signal Not Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g. imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only. Laboratory/Test Information GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.

Methylation Approach Had One of the Highest Cancer Signal Detection Sensitivities and Best Predicted Cancer Signal Origin of the Evaluated Technologies Approach Informed Development of Galleri® Multi-Cancer Early Detection Blood Test Analysis is Part of Extensive and Systematic Comparison of Cancer Specific Cell-Free DNA Features for Multi-Cancer Early Detection   MENLO PARK, Calif., Nov. 17, 2022 – GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced findings from a fundamental substudy of the Circulating Cell-free Genome Atlas (CCGA; NCT02889978) study, demonstrating that methylation had the most promising combination of cancer detection and prediction of cancer signal origin when compared with other evaluated approaches. This is the first rigorous and systematic comparison of various genomic measures from circulating cell-free DNA (cfDNA) for multi-cancer early detection (MCED) testing, and the largest comprehensive genome-wide comparison of cfDNA approaches. Findings were published online in Cancer Cell in a manuscript titled “Evaluation of Cell-Free DNA Approaches for Multi-Cancer Early Detection.” “Results from the CCGA study formed the basis for how we developed and refined the Galleri test—it’s our origin story and the foundation of our work to transform cancer care with a simple blood test,” said Amoolya Singh, Ph.D., Senior Vice President of Data Science and Chief Scientific Officer at GRAIL. “This defining study made it possible to carefully design a population screening test with a high specificity and low false-positive rate for cancer detection. When combined with standard screenings, this test has the potential to improve detection of cancer in asymptomatic individuals.” The CCGA Discovery Substudy, the first of three pre-planned substudies of the case-controlled CCGA study, evaluated multiple potential approaches to blood-based multi-cancer early detection (MCED) in a cohort of 2,800 individuals. These approaches included whole-genome sequencing, whole-genome methylation sequencing, and ultra deep targeted sequencing. Together this covered eight classifiers including methylation, somatic copy number alterations, somatic mutations, and a ninth pan-feature classifier. Criteria for evaluation included sensitivity (a test’s ability to correctly identify people with cancer) at high (98%)  specificity (a test’s ability to correctly identify people without cancer) and cancer signal origin prediction (a test’s ability to predict the anatomical localization or cell of origin of the detected cancer signal). The CCGA Discovery Substudy showed that among the evaluated classifiers, those using whole-genome methylation had one of the highest cancer signal detection sensitivities at 98% specificity. Additionally, out of the evaluated approaches, whole-genome methylation had the best predicted cancer signal origin. Findings from CCGA Discovery, along with the other substudies, were instrumental in developing, refining and validating the targeted methylation platform used in the Galleri® MCED test, which applies next-generation genomic sequencing, advanced data science and machine learning to detect a shared cancer signal across more than 50 types of cancer at 99.5% specificity and accurately predict where the signal originated in the body through a simple blood draw. Test performance was consistent in the interventional PATHFINDER study, which was recently presented at the European Society for Medical Oncology Congress 2022. CCGA Discovery evaluated various cfDNA measures in three prototype assays and nine prototype machine learning classifiers to determine the most promising approach for an MCED test with a low false-positive rate and sufficient sensitivity to improve outcomes for individuals who undergo screening. The substudy included 2,800 participants—1,628 with cancer and 1,172 without cancer (non-cancer). Blood samples from individuals with cancer were demographically matched to non-cancer individuals to reduce statistical uncertainty. Patients with cancer diagnosed by screening or by clinical presentation were enrolled before starting definitive therapy. The substudy implemented innovations in cancer detection evaluation, including study design, custom distributed and cloud computing, and the introduction of a novel measure: circulating tumor DNA allele fraction, defined as the fraction of tumor-distinguishing methylation marks in a cfDNA sample (i.e., the available signal). Furthermore, it introduced the metric of clinical limit of detection (cLOD) to measure cancer detection as a function of cfDNA tumor fraction -- a more robust performance metric than sensitivity, which is highly dependent on study cancer type and stage composition. “To be able to meaningfully compare ct-DNA assays in the future, the clinical limit of detection must be assessed,” added Singh. “The CCGA Discovery analysis is the first direct head-to-head comparison of multiple approaches that we are aware of. Notably, CCGA Discovery identified methylation features in ct-DNA as having the leading combination of cancer detection and cancer signal origin performance. This motivated the development of an improved targeted methylation platform that underlies Galleri today with substantially improved performance.”   ###   About the CCGA Study The CCGA study is a prospective, multi-center, case-controlled, longitudinal study designed to characterize the landscape of genomic cancer signals in the blood of people with and without cancer. The study is collecting de-identified biospecimens and clinical data from more than 15,000 participants across 142 sites in the U.S. and Canada, including both people who had cancer at the time of enrollment (newly diagnosed, and not yet received treatment) and people who did not have a known cancer diagnosis. Participants will be followed annually for up to five years. A separate pre-specified substudy from CCGA involving 4,077 participants was previously published in the Annals of Oncology in September, 2021.   About GRAIL’s MCED Clinical Development Program The Galleri clinical development program consists of studies that collectively include more than 335,000 participants together with what is believed to be the largest linked datasets of genomic and clinical data in the field of cancer research. GRAIL’s program includes the foundational CCGA development and validation study, the interventional PATHFINDER and PATHFINDER 2 studies, the NHS-Galleri randomized, controlled clinical study, the STRIVE and SUMMIT observational studies, and the REFLECTION real-world registry.  The largest of these, the NHS-Galleri trial, has enrolled 140,000 participants with the primary objective of a reduction in late-stage cancer diagnoses, thought to be a necessary prerequisite for ascertaining a mortality reduction.   About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission. For more information, visit grail.com.   About Galleri® The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older. For more information about Galleri, visit galleri.com.   Important Galleri Safety Information The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.   Laboratory/Test Information GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.

Through Carrum Health’s Network of Customers, Eligible Employees Will Have Access to GRAIL’s Galleri® Multi-Cancer Early Detection (MCED) Test    MCED Test Offered as Part of Comprehensive Value-Based Cancer Care to Improve Outcomes and Reduce Costs   MENLO PARK, Calif., and SAN FRANCISCO, Oct. 13, 2022 — GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, and Carrum Health, the first digital health company connecting employers and employees to Centers of Excellence (COEs) through a technology-powered, value-based care platform, today announced a first-of-its-kind partnership to include the Galleri® multi-cancer early detection (MCED) test as part of Carrum Health’s oncology offering to self-insured employers. This product integration will enable employers who offer Carrum Health benefits to provide eligible employees the Galleri test as part of the comprehensive cancer care Carrum delivers. “In developing Carrum’s comprehensive oncology offering we’ve carefully selected partners who share in our mission to tackle both the rising costs of cancer care and solutions that vastly improve the patient experience,” said Sach Jain, CEO and founder of Carrum Health. “GRAIL’s early cancer detection test is a critical component in a comprehensive oncology offering and we’re thrilled to extend this benefit to Carrum members.” In a clinical study, the Galleri test demonstrated the ability to detect a shared signal across more than 50 types of cancers, over 45 of which lack recommended screening tests today. Using advanced genomics and machine learning, the test also predicts the origin of the cancer signal, which enables targeted diagnostic evaluation. Recently announced results from the PATHFINDER clinical trial showed adding the Galleri MCED test to standard of care screening more than doubled the number of cancers detected, and the test predicted where a cancer signal originated with 97% accuracy. “An MCED test like Galleri complements existing screenings and represents a new approach with the potential to find cancer at earlier stages and to improve healthcare outcomes and efficiencies,” said Bob Ragusa, chief executive officer at GRAIL. ”We are proud to partner with Carrum Health, who shares our commitment to transforming cancer care and reducing rising healthcare costs.” Members who receive a signal detected from the Galleri test can work with a Carrum Health COE for diagnostic evaluation and guideline-concordant treatment planning. As part of Carrum Health’s comprehensive offering, members are paired with a personal patient care specialist who handles all administrative aspects of the program and guides the member throughout the entire journey. Once treatment starts with a selected provider, patients and their care team can leverage the COEs’ expertise for input and guidance as needed and will have access to an oncology-certified nurse and remote support services. ### About Carrum Health Carrum Health offers the first value-based complete surgical care platform that combines the benefits of a bundled payments Centers of Excellence (COE) with surgical guidance and coordination to deliver the highest quality, most appropriate care. By connecting self-insured employers with the top 10% of doctors and facilities across the nation, Carrum reduces unnecessary procedures by as much as 30% and aligns cost and care incentives to save employers up to 45% per episode of care, all validated by peer-reviewed publications. Carrum’s award-winning technology gives members access to a mobile app and Care Specialist that guides them through the surgery process, and a seamless platform integration to make COE adoption plug-and-play for employers. Backed by Tiger Global, Carrum was named to the 2021 CB Insights Digital Health 150 and named one of the best places to work in 2022 by Built In. The company, founded in 2014, is headquartered in Silicon Valley. For more information, visit carrumhealth.com.   About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021. For more information, visit grail.com.   About Galleri® The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test is available in the U.S. and requires a prescription from a licensed healthcare provider. The Galleri test should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older. All cells—cancer and healthy ones—shed DNA, which is called cell-free DNA, into the bloodstream. One of the “hallmarks of cancer” is when methyl groups are added to DNA. This does not alter the DNA code but it can alter gene expression. Methylation patterns on tumor-derived cell-free DNA carry cancer-specific signals and are therefore very helpful in detecting cancer and determining its origin. Galleri uses next-generation sequencing and machine learning algorithms to analyze these methylation patterns of cell-free DNA in the bloodstream. For more information about Galleri, visit galleri.com.   Important Galleri Safety Information The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.   Laboratory/Test Information GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.

First-of-its-kind Galleri® Multi-Cancer Early Detection blood test can screen for multiple cancers through a single blood draw.   DETROIT and MENLO PARK, Calif. – (Sept. 22, 2022) – Henry Ford Health, one of the nation’s leading academic medical centers recognized for excellence in clinical care, research and education, and GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced Henry Ford Health as the first healthcare provider in Michigan to offer Galleri®, GRAIL’s Multi-Cancer Early Detection (MCED) blood test. Henry Ford is among an early group of healthcare providers in the U.S. to offer this MCED test. “We are entering an era of unprecedented ability to detect cancer at its earliest stages, which may ultimately help save many lives,” said Adnan Munkarah, M.D., Chief Clinical Officer at Henry Ford Health. “Diagnosing and treating cancer at an earlier stage often leads to more favorable outcomes. We are excited to offer this MCED blood test, which research shows can detect a cancer signal shared across more than 50 types of cancer through a single blood draw.” The Galleri test is intended for use in those who are at an elevated risk of cancer, such as individuals ages 50 or older. Some younger people may also have an elevated risk of cancer, which is why Henry Ford is making the Galleri test available to patients who are 22 years or older, have no history of cancer or have been cancer-free at least three years, and are not currently pregnant. “We believe that multi-cancer early detection tests like Galleri are the new front on the war against cancer and will enable us to dramatically increase cancer detection from screening in the population, with the goal of improving public health,” said Bob Ragusa, Chief Executive Officer at GRAIL. “We are excited to work with Henry Ford Health in adding Galleri as a complement to U.S. guideline-recommended cancer screenings.” Galleri MCED test can detect many cancers that are not commonly screened for today to allow for earlier treatment, and can be incorporated into a routine healthcare visit. If a cancer signal is found, the results can point to where in the body the cancer is coming from. This can help healthcare providers guide next steps. “Routine cancer screenings remain essential for early detection,” said Ben Movsas, M.D., Medical Director of Henry Ford Health Cancer. “But a MCED blood test can be used in addition to guideline-recommended cancer screenings, such as mammography, colonoscopy, prostate-specific antigen or cervical cancer screening. In a clinical study, the test also detected some cancer types, such as pancreatic, ovarian and esophageal, that currently lack routine recommended screening guidelines. This can provide a way to detect cancers earlier that are often not detected until a later stage.” All cells in the body release DNA into the bloodstream, but DNA from cancer cells is different from the DNA of healthy cells. The Galleri test looks at the DNA in a patient’s blood to determine if any of it may have come from cancer cells. In a clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancer, more than 45 of which lack recommended screening tests today. Final results from the first PATHFINDER study, an interventional study that examined how well an MCED test can be integrated into clinical practice, were presented at the European Society for Medical Oncology (ESMO) Congress 2022 and demonstrated Galleri’s performance was consistent with findings from previous observational and case-controlled studies, underscoring the potential real-world ability of Galleri to find more cancers in earlier stages. “For many people, routine cancer screenings are a part of the regular care they receive from their primary care physician,” said Dan Passerman, D.O., Chair of Family Medicine at Henry Ford Health. “The ability to include this test in a routine visit, and to obtain actionable health information as a result, will help people protect their health in a very meaningful and convenient way.” Because the test is not currently covered by insurance, the Galleri MCED test is an out-of-pocket cost. Patients may be eligible to participate in the interventional PATHFINDER 2 study, which is evaluating the implementation and performance of Galleri in a clinical care setting. The study is currently enrolling individuals who meet the eligibility requirements, which include: 50 years or older and receive care at Henry Ford Health. Have never been diagnosed with cancer or have been cancer-free at least three years. Are not participants in previous or ongoing GRAIL sponsored studies. Henry Ford team members and their dependents who are enrolled in a Health Alliance Plan (HAP) of Michigan insurance plan may be eligible for a test at no cost. Galleri is available by physician order only. Those who may be interested in the Galleri test should consult with their Henry Ford primary care physician to determine whether the test is appropriate for them.  To learn more about the Galleri test at Henry Ford Health, visit henryford.com/cancerbloodtest.   ###   About Henry Ford Health Serving communities across Michigan and beyond, Henry Ford Health is committed to partnering with patients and members along their entire health journey. Henry Ford Health provides a full continuum of services – from primary and preventative care, to complex and specialty care, health insurance, a full suite of home health offerings, virtual care, pharmacy, eye care and other healthcare retail. It is one of the nation’s leading academic medical centers, recognized for clinical excellence in cancer care, cardiology and cardiovascular surgery, neurology and neurosurgery, orthopedics and sports medicine, and multi-organ transplants. Consistently ranked among the top five NIH-funded institutions in Michigan, Henry Ford Health engages in more than 2,000 research projects annually. Equally committed to educating the next generation of health professionals, Henry Ford Health trains more than 4,000 medical students, residents and fellows every year across 50+ accredited programs. With more than 33,000 valued team members, Henry Ford Health is also among Michigan’s largest and most diverse employers, including nearly 6,000 physicians and researchers from the Henry Ford Medical Group, Henry Ford Physician Network and Jackson Health Network. The health system is led by President and CEO Robert G. Riney and serves a growing number of customers across 250+ locations throughout Michigan including five acute care hospitals, two destination facilities for complex cancer and orthopedics and sports medicine care, three behavioral health facilities, primary care and urgent care centers.   About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021. For more information, visit grail.com.   About Galleri® The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older. For more information about Galleri, visit galleri.com.   Important Galleri Safety Information The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.   Laboratory/Test Information GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.

Highlights power of strategic industry partnerships to promote preventive health and empower well-being   BOSTON (September 20, 2022) – Today, John Hancock, the US division of Toronto-based Manulife (NYSE: MFC), announced it is offering access to GRAIL’s Galleri® multi-cancer early detection test to a pilot group of existing customers through the John Hancock Vitality Program, in collaboration with reinsurer Munich Re Life US. As the first life insurance carrier to make this breakthrough screening technology available, John Hancock is enabling eligible customers to take proactive steps to better understand and make more informed choices about their health. According to the American Cancer Society, more than 600,000 people die from cancer each year in the United States and many cancers show no symptoms until later stages, when treatment options may be limited.1 Early detection of cancer can improve cancer outcomes, yet today, many cancers are detected in late stages because only five types have recommended screenings — breast, cervical, colon, lung, and prostate cancers. John Hancock Vitality is available with the company’s life insurance policies — offering education, support, incentives, and rewards to encourage customers to take everyday steps toward a longer, healthier, better life. The Galleri test, the newest feature to be added to the program for eligible customers, is a first-of-its-kind multi-cancer early detection blood test. In a clinical study, the Galleri test demonstrated the ability to detect a signal from more than 50 types of cancers, over 45 of which lack recommended screening tests. The test can also help determine where in the body cancer may be located, which can then guide diagnostic follow up. “At John Hancock, we are deeply invested in helping our customers live longer, healthier, better lives. Almost everyone has experienced the devastating effects of cancer in some way and by making this early screening technology available, we can help change the cancer narrative for some of our customers,” said Brooks Tingle, President and CEO of John Hancock Insurance. “As a life insurer, we can use our unique position to make a powerful impact. As such, we are bringing together carriers, distributors, reinsurers and innovative technology companies to transform our customers’ experience while empowering them with knowledge about their health, ultimately improving lives.” Individual test results will not be shared with John Hancock and will have no impact on a customer’s current life insurance coverage or pricing, or status in the Vitality program. John Hancock has partnered with GRAIL’s exclusive reinsurance partner, Munich Re Life US, to bring this offering to life insurance customers for the first time, with support from Swiss Re and SCOR. John Hancock has also collaborated with M Financial Group, an early partner of GRAIL. “This collaboration amongst forward-thinking organizations, within the insurance industry, highlights the power of strategic industry partners rallying around an aligned mission to help fight cancer,” said Bob Ragusa, Chief Executive Officer at GRAIL. “With this initiative by John Hancock to make Galleri available to eligible customers, as a complement to other cancer screenings, we can help change the status quo and continue in our goal to dramatically increase cancer detection from screening in the population to improve public health.” Marc Giguere, President and CEO of Munich Re Life US commented, “Munich Re Life US has a responsibility to society to help advance early cancer detection and treatments that produce better outcomes for cancer patients. With this partnership, we are helping to bridge the gap between medical research and advancements and their impact on life insurance by bringing innovative solutions to our carrier partners. Munich Re Life US is incredibly proud to embark on this journey with GRAIL and John Hancock.” Through this pilot, John Hancock will assess customer adoption of Galleri, as well as the overall user experience, before deciding how best to offer the test in the future. The Galleri test does not replace recommended routine cancer screenings. Cancer Facts and Figures 2021 https://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-and-figures/2021/cancer-facts-and-figures-2021.pdf   Disclaimer  Galleri is a registered trademark of GRAIL, LLC (“Grail”). The test is manufactured and distributed by GRAIL. John Hancock is not an affiliate of GRAIL. John Hancock does not provide medical advice and is not responsible for the accuracy or performance of the Galleri test. There is no coordination between any health benefits you may receive from an insurance policy, health plan, or any other wellness programs you may be enrolled in. Galleri is not a test to confirm or rule out genetic or other conditions that may indicate a predisposition to cancer. It is important to underscore that Galleri is not a means of diagnosis, but rather a tool to help individuals screen for cancer earlier. The Galleri test does not replace recommended routine cancer screenings. The Galleri test has not been cleared or approved by the Food and Drug Administration, but has received a breakthrough device designation by the FDA. GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists (CAP). As GRAIL pursues FDA approval, they have launched Galleri as a Laboratory Developed Test in compliance with applicable regulatory requirements, backed by evidence.  The Galleri test is only available to registered John Hancock Vitality PLUS members who are 50 years of age or older, have completed the Vitality Health Review (VHR) for the current program year, and whose policies were issued between 9/1/2019 and 3/31/2022. For eligible policies with coverage amounts of $500,000 or greater, 100% of the cost of the test will be subsidized. For policies with less than $500,000 in coverage, 50% of the cost of the test will be subsidized. The Galleri test through The John Hancock Vitality Program is not currently available in ID, ND, NM, NY or VT. Insurance products are issued by: John Hancock Life Insurance Company (U.S.A.), Boston, MA 02116 (not licensed in New York) and John Hancock Life Insurance Company of New York, Valhalla, NY 10595   Important Safety Information The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “Cancer Signal Not Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.   ###   About John Hancock and Manulife John Hancock is a unit of Manulife Financial Corporation, a leading international financial services provider that helps people make their decisions easier and lives better by providing financial advice, insurance, and wealth and asset management solutions. Manulife Financial Corporation trades as MFC on the TSX, NYSE, and PSE, and under 945 on the SEHK. Manulife can be found at manulife.com. One of the largest life insurers in the United States, John Hancock supports more than ten million Americans with a broad range of financial products, including life insurance and annuities. John Hancock also supports US investors by bringing leading investment capabilities and retirement planning and administration expertise to individuals and institutions. Additional information about John Hancock may be found at johnhancock.com   About Vitality Guided by a core purpose of making people healthier, Vitality is the leader in improving health to unlock outcomes that matter. By blending industry-leading smart tech, data, incentives and behavioral science, we inspire healthy changes in individuals and their organizations. As one of the largest wellness companies in the world, Vitality brings a dynamic and diverse perspective through successful partnerships with the most forward-thinking insurers and employers. More than 20 million people in 31 markets engage in the Vitality program. For more information, visit vitalitygroup.com or follow us on Twitter and LinkedIn. Vitality is the provider of the John Hancock Vitality Program in connection with policies issued by John Hancock. John Hancock Vitality Program rewards and discounts are available only to the person insured under the eligible life insurance policy, may vary based on the type of insurance policy purchased and the state where the policy was issued, are subject to change and are not guaranteed to remain the same for the life of the policy. Insurance policies and/or associated riders and features may not be available in all states.   About Munich Re Life US As one of the leading life reinsurers in the United States, Munich Re Life US partners with insurers to leverage smart and connected data, embrace new ideas and technologies, make confident decisions at speed and scale, and gain an exponential understanding of underlying risks. Munich Re Life US is well known in the industry as an innovation leader with extensive technical depth. Its optimized solutions and capital management expertise expand beyond market leading offerings in individual life, group, individual disability and living benefits reinsurance, to a global center for predictive analytics, automated underwriting, digital partnerships and standard-setting underwriting and medical capabilities. Munich Re Life US believes the digital economy offers an unprecedented opportunity for the life insurance industry to rapidly advance risk assessment and close the widening global underinsured gap. Munich Re Life US, incorporated as Munich American Reassurance Company, is a subsidiary of Münchener Rückversicherungs- Gesellschaft Aktiengesellschaft in München (“Munich Re”). It has high ratings for financial strength from A.M. Best Company and Standards & Poors. Munich Re Life US serves clients throughout the United States from its two locations in New York and Atlanta.   About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021. For more information, visit grail.com.   About Galleri® The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or helps to determine where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older. For more information about Galleri, visit galleri.com. MLINY091422686-1

Adding Multi-Cancer Early Detection (MCED) Screening to Standard of Care Screening More Than Doubled the Number of Cancers Detected 71% of Participants With MCED-Detected Cancers Had Cancer Types With No Routine Screening Tests Available Approximately Half of the MCED-Detected New Cancers Were Stage I or II MCED-Predicted Cancer Signal Origin Had 97.1% Accuracy and Enabled Targeted Diagnostic Evaluations MCED Screening was Implemented in Adults With Elevated Cancer Risk Without Study-Related Serious Adverse Events Participants Reported High Satisfaction and Low Negative Psychological Impact With MCED Screening MENLO PARK, Calif., September 11, 2022--GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced final results from the interventional PATHFINDER study, which evaluated multi-cancer early detection (MCED) screening using a blood test and the clinical care pathways following a “cancer signal detected” MCED test result in 6,662 individuals aged 50 years or older, an age group at elevated risk for cancer. Results were presented in a proffered paper session at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris. “The PATHFINDER study is an exciting first step towards fundamental change in the approach to cancer screening. The study found cancer in about 1% of participants including types for which there is no established screening method. The study demonstrated the feasibility of this paradigm and solid test performance,” said Deb Schrag, MD, MPH, chair, Department of Medicine at Memorial Sloan Kettering Cancer Center in New York. “Although continued public health efforts to optimize adherence to existing screening strategies that have been proven effective are critical, this study provides a glimpse of what the future may hold—the opportunity for screening using blood tests to detect various types of cancers at their earliest and most treatable stages.” PATHFINDER was a single-arm study that measured the time required to achieve diagnostic resolution (i.e., healthcare provider-defined end to the diagnostic evaluation) following a “cancer signal detected” MCED blood test result and the number and types of diagnostic tests that were used (primary endpoint). MCED test performance was a key secondary endpoint, including positive predictive value (PPV, the percent of cancer signal detected results that were confirmed to be cancer) and the accuracy of the predicted cancer signal origin (CSO). Participants were followed for 12 months after enrollment. If a participant had a negative MCED test at enrollment but developed a cancer within the 12-month follow-up, it was counted as an MCED false negative. Test performance was measured using both an earlier version of Galleri (MCED-E) and a refined version of Galleri (MCED-Scr). The earlier version of the test was refined to reduce the detection of pre-malignant hematologic conditions, which are fairly common, and improve prediction of the cancer signal origin. The study was completed with the earlier version of the test (MCED-E) and then the blood samples were retested in a pre-specified retrospective analysis using the refined Galleri test (MCED-Scr). “When added to standard of care screening, MCED testing more than doubled the number of cancers detected compared to standard screening alone. In fact, Galleri detected more cancers than all U.S. Preventive Services Task Force-recommended standard single cancer screenings combined. These included Stage I cancers of the liver, small intestine, and uterus, and Stage II pancreatic, bone, and oropharyngeal cancers,” said Jeffrey Venstrom, MD, chief medical officer at GRAIL. “This is particularly notable given the PATHFINDER population was heavily screened with higher-than-average rates for mammography, colonoscopy, and low-dose CT lung scans.” A cancer signal was detected in 92 participants, two of whom began workup prior to the return of their MCED test results. Of these, 35 participants were diagnosed with 36 cancers. Among the confirmed cancers, 71% (25/35) of participants had cancer types that have no routine cancer screening available. Nearly half (48%) of the non-recurrent cancers were found in early-stages (Stage I or II). Standard of care screening identified 29 cancers, and another 56 cancers were diagnosed because symptoms appeared or tumors were found incidentally or from monitoring for cancer recurrence. The cancer signal origin prediction had a 97% accuracy and directed physician clinical workup, leading to resolution of the cancer diagnosis in less than three months for most participants with a true positive signal (73%), and in less than two months for half of them. The median time to diagnostic resolution was longer for false positive results (162 days); 44% of these participants had scheduled follow-up imaging or procedures three or more months later, contributing to the longer time to resolution. Most participants underwent imaging procedures, such as scans or MRIs, following true and false-positive results. As expected, most true positive participants (82%) underwent an invasive procedure to confirm a cancer diagnosis. Three underwent endoscopies triggered by the predicted cancer signal origin, and 24 had procedures triggered only by abnormal imaging, physical, or laboratory findings, including three surgical biopsies. A smaller proportion of false positive participants had invasive procedures (30%). Five had procedures triggered by CSO predictions (five endoscopies, one endometrial biopsy and one pap smear), and 12 had procedures triggered only by abnormal imaging, physical, or laboratory findings, or by their medical history. No study-related serious adverse events were reported as a result of MCED testing in the study, and there were no adverse events reported from diagnostic workups. The PPV was 43.1% with the refined test and 38.0% with the earlier version. Specificity, or the percentage of true negatives, of the refined test was 99.5%, and 99.1% with the earlier version, and the false positive rate for both versions was less than 1%. Test performance was consistent with the interim analysis and the previous case-controlled Circulating Cell-free Genome Atlas (CCGA) study. “The refinements we made to the earlier version of Galleri resulted in clinically expected outcomes and had the intended result of reducing false positives from hematological signals,” added Venstrom. “While PATHFINDER was not designed to determine sensitivity or the number of cancer types detected by Galleri, 11 different cancer types were detected in this study that have no standard screening today, and the false positive rate was less than 1%. In the much larger CCGA case-control study, the Galleri test detected over 50 types of cancer.” An analysis of participant-reported outcomes of anxiety, distress, and satisfaction related to MCED testing from the study were also presented at the ESMO Congress 2022. PATHFINDER participants completed patient-reported outcomes assessments before MCED testing, after receiving MCED test results, and at the end of the study. The analysis found 97.1% of participants reported a high level of satisfaction with the test, including those who had both true positive (92%) and false-positive (82.3%) results. As expected, a higher level of anxiety was seen in participants following a positive result, but that resolved to pre-MCED test levels within 12 months. Preliminary Real World Analysis Generally Consistent with PATHFINDER Results GRAIL conducted an analysis of the first 38,154 Galleri commercial test results to monitor Galleri performance in a real world setting. The analysis showed a 1.1% cancer signal detection rate. As seen in clinical trials, the signal detection rate increases with age and male sex, consistent with the National Cancer Institute’s Surveillance, Epidemiology, and End Results Program (SEER) statistics. Among 326 patients with a positive cancer signal detected result and short-term follow up (as voluntarily reported by the ordering physicians), 108 cancers have been confirmed by the ordering providers to-date, representing 28 different cancer types. Of the 108 patients with a provider-confirmed cancer diagnosis, 64 had no recommended cancer screening test (59%). Provider-confirmed cancers include, among others, Stage I pancreatic, head and neck, endometrial, esophageal, and gastrointestinal stromal tumor (GIST) cancers and Stage II rectal, liver, and head and neck cancers. “Every year, we lose more than 600,000 loved ones to cancer in the U.S. alone. Unfortunately, the burden of cancer will grow with the demographic tidal wave, as the absolute risk of developing any cancer increases as we get older,” said Josh Ofman, MD, MSHS, president at GRAIL. “Bending the cancer mortality curve will require earlier detection of more cancer. However, a world with more single cancer screening tests is simply clinically and economically untenable as each single cancer screening test has a false positive rate of 5-10%. We need to expand from screening for individual cancers to also screening individuals for cancer. We believe MCED tests can enable this paradigm shift by finding more types of cancer at earlier stages with a single blood test.” About GRAIL’s MCED Clinical Development Program The Galleri clinical development program consists of studies that collectively include more than 335,000 participants—and what is believed to be the largest linked datasets of genomic and clinical data in the cancer field. GRAIL’s program includes the foundational CCGA development and validation study, the interventional PATHFINDER and PATHFINDER 2 studies, the NHS-Galleri randomized, controlled clinical study, the STRIVE and SUMMIT observational studies, and the REFLECTION real-world registry. The largest of these, the NHS-Galleri trial, has enrolled 140,000 participants with the primary objective of a reduction in late-stage cancer diagnoses, thought to be a necessary prerequisite for a mortality reduction. About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021. For more information, visit grail.com. About Galleri® The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test is available in the U.S. and requires a prescription from a licensed healthcare provider. The Galleri test should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older. All cells—cancer and healthy ones—shed DNA, which is called cell-free DNA, into the bloodstream. One of the "hallmarks of cancer" is when methyl groups are added to DNA. This does not alter the DNA code but it can alter gene expression. Methylation patterns on tumor-derived cell-free DNA carry cancer-specific signals and are therefore very helpful in detecting cancer and determining its origin. Galleri uses next-generation sequencing and machine learning algorithms to analyze these methylation patterns of cell-free DNA in the bloodstream. For more information about Galleri, visit galleri.com. Important Galleri Safety Information The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only. Laboratory/Test Information GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.

Final Data From One of the Largest Multi-Cancer Early Detection Studies in an Intended Use Population   MENLO PARK, Calif., Sept. 8, 2022 — GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, today announced final results from the interventional PATHFINDER study will be presented at the European Society for Medical Oncology (ESMO) Congress 2022 in Paris. PATHFINDER data evaluating the Galleri® multi-cancer early detection (MCED) blood test will be shared in a September 11 proffered paper session. Participant-reported outcomes will also be presented, including satisfaction related to MCED testing, ongoing adherence with standard of care screening, and information related to participants’ anxiety and distress. Interim results from the PATHFINDER study were presented at the 2021 American Society of Clinical Oncology (ASCO) Annual Meeting. The PATHFINDER single-arm interventional study was designed to evaluate the clinical care pathways following a “cancer signal detected” Galleri test result, measure the time required to achieve diagnostic resolution (primary endpoint), and assess the implementation and performance of Galleri in a clinical care setting. “Despite 50 years of waging a war on cancer, cancer is poised to become the world’s number one killer, in large part because most cancers are diagnosed too late. While current screening tests are saving lives, they are not enough, and the status quo in cancer screening is simply unacceptable. In the United States, we routinely screen for only five cancers yet most cancer deaths occur from cancers we are not looking for. Our current approach using decades old technology with suboptimal adherence is simply not finding enough cancer in the population. We must transition from only looking for individual cancers to also looking at individuals for many cancers,” said Josh Ofman, MD, MSHS, president at GRAIL. “We are excited to share the final PATHFINDER results, which provide important insights about the feasibility of our first-of-its-kind MCED technology, the clinical care pathways following a “cancer signal detected” result, and Galleri’s potential to detect more cancers in their earlier stages as a complement to standard screenings.” The PATHFINDER study enrolled 6,662 individuals aged 50 years or older, an age group at elevated risk for cancer, but with no suspicion of active cancer. Participants were enrolled across 11 sites, including the Cleveland Clinic, Dana-Farber Cancer Institute, Mayo Clinic,  Oregon Health & Science University, Sutter Health and the US Oncology Network. Results will be presented from both an earlier version of Galleri (MCED-E) and a pre-specified retrospective analysis evaluating the current version of the Galleri test (MCED-Scr) using banked blood samples. Selected GRAIL presentations at ESMO include: A Prospective Study of a Multi-Cancer Early Detection Blood Test (Presentation #903O) Session Type: Proffered Paper Session Date/Time: Sunday, Sept. 11, 16:30 – 16:40 p.m. CEST (10:30 - 10:40 a.m. EST) Location: 7.3.O - Orleans Auditorium Speaker: Deborah Schrag, MD, MPH, chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK) Evaluation of Anxiety, Distress and Satisfaction With a Multi-Cancer Early Detection Test (Presentation #908P) Session Type: e-Poster Date/Time: Sunday, Sept. 11 Speaker: Deborah Schrag, MD, MPH, chair of the Department of Medicine at Memorial Sloan Kettering Cancer Center (MSK) Time to Diagnosis Among Patients with Cancer in the US (Presentation #1318MO) Session Type: Mini Oral Session Date/Time: Monday, Sept. 12, 17:10 - 17:15 CEST (11:10 - 11:15 a.m. EST) Location: 7.3.M - Marseille Auditorium Speaker: Matthew Gitlin, PharmD, BluePath Solutions Abstracts are available on the ESMO Congress 2022 website. Additional data from the PATHFINDER study will be presented at the Congress.   ###   About GRAIL’s MCED Clinical Development Program The Galleri clinical development program consists of studies that collectively include more than 335,000 participants - and what is believed to be the largest linked datasets of genomic and clinical data in the cancer field. GRAIL’s program includes the foundational CCGA development and validation study, the interventional PATHFINDER and PATHFINDER 2 studies, the NHS-Galleri randomized, controlled clinical study, the STRIVE and SUMMIT observational studies, and the REFLECTION real-world registry.  The largest of these, the NHS-Galleri trial, has enrolled 140,000 participants with the primary objective of a reduction in late-stage cancer diagnoses, thought to be a necessary prerequisite for a mortality reduction.   About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021. For more information, visit grail.com.   About Galleri® The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older. All cells - cancer and healthy ones - shed DNA, which is called cell-free DNA, into the bloodstream. One of the "hallmarks of cancer" is when methyl groups are added to DNA. This does not alter the DNA code but it can alter gene expression.  Methylation patterns on tumor-derived cell-free DNA carry cancer-specific signals and are therefore very helpful in detecting cancer and determining its origin. Galleri uses next-generation sequencing and machine learning algorithms to analyze these methylation patterns of cell-free DNA in the bloodstream. For more information about Galleri, visit galleri.com.   Important Galleri Safety Information The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only.   Laboratory/Test Information GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.  

NHS-Galleri Trial is Evaluating Clinical Utility of GRAIL’s Galleri®, a Multi-Cancer Early Detection Test, Alongside Current Standard of Care in England NHS-Galleri Trial Prioritized Equitable Recruitment Approaches Designed to Achieve Representation of People from Minority Ethnic Backgrounds   MENLO PARK, Calif., July 18, 2022 — GRAIL, LLC, a healthcare company whose mission is to detect cancer early when it can be cured, announced today that the NHS-Galleri trial successfully completed enrollment in just over 10 months. The trial, which is the largest-ever study of a multi-cancer early detection (MCED) test, has enrolled 140,000 healthy volunteers aged 50-77 from select regions throughout England who have not had a cancer diagnosis or undergone treatment for cancer in the last three years. The NHS-Galleri trial is a randomized, controlled clinical trial being conducted in England alongside standard cancer screening with diagnostic follow-up in the NHS’ clinical practice setting. Regions were selected to include areas of high cancer mortality, socioeconomic disparities, and ethnic diversity, using innovative methods to enroll a study population with participants traditionally less likely to take part in medical research. Participants visited one of 150 mobile clinics operating at locations around England and were recruited through activities including community group briefings, leaflet distribution in community settings, engagement through community champions, and targeted social media campaigns. “Meeting the goal of enrolling 140,000 people is a significant achievement, allowing us to evaluate an unprecedented number of volunteers without symptoms of cancer and representing diverse socio-economic and ethnic populations,” said Charles Swanton, MD, PhD, a cancer researcher and oncologist at University College London and the Francis Crick Institute, chief clinician at Cancer Research UK, and co-chief investigator of the study. “Whilst the first year of the trial may pick up cancers that have existed for some time, the second and third years provide the best opportunity to explore the expected benefits of picking up new cancers at an early stage when treatment is generally more successful. By screening participants annually over three years, we will be able to explore how MCED tests can be used alongside existing NHS screening programs.” The study’s aim is to determine if the Galleri test, alongside standard cancer screening, can find asymptomatic cancers at earlier stages than they are found in clinical care today. The study will assess absolute numbers of stage 3 and 4 cancers diagnosed following three annual Galleri tests. The first screen will aim to identify the prevalent cancers in the population, while the second and third screens will aim to identify cancers that have newly emerged. "NHS-Galleri has set a new standard in the speed of set-up and recruitment to clinical trials," said Professor Peter Sasieni, Director of The Cancer Research UK & King’s College London Cancer Prevention Trials Unit and one of the trial’s lead investigators. "Previous trials of this magnitude would typically have taken five times as long. Accelerating research means that we will find out sooner whether new technology has a role in the control of cancer and, if it does, introducing it within the NHS quickly so that more people can benefit.” This trial supports the NHS Long Term Plan ambition to catch three quarters of cancers at an early stage, when they are less advanced, and treatment has a higher chance of being successful and potentially curative. Based on initial results, the NHS may roll out the test to an additional 1 million people. “Today marks an important milestone in our long-term efforts to catch and treat cancer earlier,” said Amanda Pritchard, chief executive at NHS. “We know that certain cancers are harder to detect and a late diagnosis can be devastating for patients and their families, and this trial means thousands could benefit from a diagnosis even before symptoms appear.” In a previous clinical study, the Galleri test demonstrated the ability to detect a shared signal from more than 50 types of cancer, many of which lack recommended screening tests today in the UK. Early clinical trials report that GRAIL’s Galleri test has a false positive rate under 1% and can predict where a cancer signal originated with 89% accuracy. “We are so grateful for the public’s enthusiasm for this trial and to all those who have volunteered,” said Sir Harpal Kumar, president at GRAIL Europe. “We are hopeful Galleri will work well alongside existing cancer screening in the UK, can provide clinicians with an accurate prediction of where the cancer is located in the body, and help the NHS reduce the number of cancers detected at a late stage.” The study is sponsored by GRAIL and is being run by The Cancer Research UK and King’s College London Cancer Prevention Trials Unit (UK), in collaboration with eight cancer alliances in England. The study design of the trial was presented at the American Society of Clinical Oncology (ASCO) Annual Meeting (Abstract #TPS6606) in June 2022.   ###   About NHS-Galleri Trial For the prospective, blinded, randomized controlled trial, study participants will provide a blood sample during three annual visits to a mobile health clinic—at baseline, year 1 and year 2. After the first visit, participants are randomized 1:1 into either the intervention or control arm. Participants in the intervention arm will have their blood tested by the Galleri test. Blood samples from subjects in the control arm will not be tested immediately, but will be stored for potential future testing. If a cancer signal is detected for those in the intervention arm, research staff will explain the result and schedule an appointment for follow-up tests at an NHS hospital local to the participant. All participants in the study will be followed for cancer and other related outcomes via NHS databases and will be reminded to continue to have guideline-recommended cancer screenings. About GRAIL GRAIL is a healthcare company whose mission is to detect cancer early, when it can be cured. GRAIL is focused on alleviating the global burden of cancer by developing pioneering technology to detect and identify multiple deadly cancer types early. The company is using the power of next-generation sequencing, population-scale clinical studies, and state-of-the-art computer science and data science to enhance the scientific understanding of cancer biology, and to develop its multi-cancer early detection blood test. GRAIL is headquartered in Menlo Park, CA with locations in Washington, D.C., North Carolina, and the United Kingdom. GRAIL, LLC, is a subsidiary of Illumina, Inc. (NASDAQ:ILMN) currently held separate from Illumina Inc. under the terms of the Interim Measures Order of the European Commission dated 29 October 2021. For more information, visit grail.com. About Galleri® The earlier that cancer is detected, the higher the chance of successful outcomes. The Galleri multi-cancer early detection test can detect signals across more than 50 types of cancer, as defined by the American Joint Committee on Cancer Staging Manual, through a routine blood draw. When a cancer signal is detected, the Galleri test predicts the cancer signal origin, or where the cancer is located in the body, with high accuracy to help guide the next steps to diagnosis. The Galleri test requires a prescription from a licensed healthcare provider and should be used in addition to recommended cancer screenings such as mammography, colonoscopy, prostate-specific antigen (PSA) test, or cervical cancer screening. It is intended for use in people with an elevated risk of cancer, such as those aged 50 or older. For more information about Galleri, visit galleri.com. Important Galleri Safety Information The Galleri test is recommended for use in adults with an elevated risk for cancer, such as those aged 50 or older. The Galleri test does not detect all cancers and should be used in addition to routine cancer screening tests recommended by a healthcare provider. Galleri is intended to detect cancer signals and predict where in the body the cancer signal is located. Use of Galleri is not recommended in individuals who are pregnant, 21 years old or younger, or undergoing active cancer treatment. Results should be interpreted by a healthcare provider in the context of medical history, clinical signs and symptoms. A test result of “No Cancer Signal Detected” does not rule out cancer. A test result of “Cancer Signal Detected” requires confirmatory diagnostic evaluation by medically established procedures (e.g., imaging) to confirm cancer. If cancer is not confirmed with further testing, it could mean that cancer is not present or testing was insufficient to detect cancer, including due to the cancer being located in a different part of the body. False-positive (a cancer signal detected when cancer is not present) and false-negative (a cancer signal not detected when cancer is present) test results do occur. Rx only. Laboratory/Test Information GRAIL’s clinical laboratory is certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and accredited by the College of American Pathologists. The Galleri test was developed, and its performance characteristics were determined by GRAIL. The Galleri test has not been cleared or approved by the U.S. Food and Drug Administration. GRAIL’s clinical laboratory is regulated under CLIA to perform high-complexity testing. The Galleri test is intended for clinical purposes.