2023 was an exciting year for GRAIL. We are seeing continued strong early adoption of GalleriⓇ, our multi-cancer early detection (MCED) blood test, surpassing 150,000 commercial tests completed. Real-world use of Galleri has detected some of the most aggressive cancers in early stages, including endometrial, esophageal, gastrointestinal stromal, head & neck, liver, pancreatic and rectal cancers. For the majority of these cancer types, there are no alternative screening options available. We are passionate about our mission to detect cancer early, when it can be cured, and energized by the powerful stories we have heard from patients who have benefited from Galleri and from physicians and health systems who are successfully implementing Galleri into their practice.
As an early leader in the field, we continue to establish strong relationships within the cancer and primary care communities, including collaborations with academic and community medical centers, opinion leaders, policy and advocacy groups. We are building on our clinical evidence program, and announced in December the Galleri-Medicare study (REACH), bringing planned enrollment for our clinical research programs to more than 385,000 participants. We were also pleased to publish results from our seminal PATHFINDER and SYMPLIFY studies in 2023 in The Lancet and The Lancet Oncology, respectively—two premier medical journals.
Cancer is a major public health crisis, and we are looking to a future where we can detect more cancers through screening, before symptoms arise, which we believe will ultimately save lives and reduce costs of care. Galleri works by detecting DNA fragments shed into the bloodstream by tumor cells. Cancer DNA has specific methylation patterns that can be used to both identify a shared cancer signal and localize that signal to a specific organ or tissue type. Galleri remains the only validated MCED test available for detection of a shared cancer signal across more than 50 cancer types.
GRAIL’s proprietary targeted methylation platform, which underlies Galleri, and our growing body of clinical and real-world data, provide us with unique insights into cancer biology that enable product improvements over time, and the development of other products beyond asymptomatic cancer screening. Potential applications for our technology in a precision oncology setting include pre-treatment prognosis, post-treatment prognosis or minimal residual disease (MRD), recurrence and clinical monitoring, and novel biomarker discovery. We are leveraging a range of ongoing collaborations with leading academic oncologists and pharmaceutical companies to further develop these product opportunities.
In 2023, GRAIL continued to build on our key strengths:
Galleri has established early commercial leadership in MCED
We are pleased to report that, to date, we have established over 100 commercial partnerships, including leading employers, payors, life insurance providers and health systems, such as HCA Healthcare—the largest health system in the U.S. Through these partnerships, we have also secured coverage of Galleri with several forward-thinking self-insurers in various sectors such as technology, healthcare, entertainment, life insurance, and financial industries.
We have established a network of more than 9,000 ordering healthcare providers in the pre-reimbursement setting, with prescribers in private practices across the United States. We are encouraged by the consistency of the cancer signal detection rate we are seeing in commercial implementation with what we have observed in our clinical studies. We continue to build the key components of our commercial and laboratory infrastructure and capabilities that are required to support rapid, population-scale testing in a reimbursed environment.
We have worked closely with providers to develop and roll-out a suite of services to ensure that patients with a Galleri positive cancer signal, and their health care providers, are supported through the confirmatory diagnostic process.
Healthcare providers are offered direct support from our medical science liaisons and access to a specialized Galleri experience council—a cohort of physicians with Galleri experience (including experts from National Cancer Institute-Designated Cancer Centers) who can provide peer-to-peer consultations. We also operate an early cancer detection board that includes third-party experts across specialties to provide consultative advice for any challenging cases.
For patients with a Galleri positive test result, we offer a support center that provides materials explaining the cancer signal detected result that can be shared with health care providers managing follow-up diagnostic evaluation.
We are driving critical scientific and clinical research in the field
We have undertaken a rigorous approach to identify the informative cfDNA-based markers of cancer through what we believe is the largest clinical program in genomic medicine. Our robust clinical development program consists of studies that are planned to collectively include more than 385,000 participants, of which more than 300,000 have already been enrolled, and includes case-controlled, observational, interventional and real-world studies.
In 2023, we reported final data from two key studies. Together with leading experts in the field, we published seminal results from the interventional PATHFINDER study in asymptomatic patients in The Lancet and from the SYMPLIFY study – the first prospective study of an MCED test in a symptomatic patient population – in The Lancet Oncology. Overall throughout the year, we published more than 20 manuscripts in clinical and scientific journals and more than 50 abstracts at renowned global congresses, including the American Association of Cancer Research (AACR), American Society of Clinical Oncology (ASCO), and the European Society of Medical Oncology (ESMO).
We also completed second year study visits for the NHS-Galleri trial with a high retention rate of 91.3%. We have entered the third year of the trial and expect to complete participant visits this coming summer. The NHS will review early metrics from the first screening round of the study in 2024, and based on those results may commence the commercial implementation of the Galleri test in up to one million patients in England over two years.
In addition, we announced plans to initiate the Galleri-Medicare (REACH) study. This study is a first of its kind real-world study designed to evaluate the clinical impact of Galleri among 50,000 Medicare beneficiaries. The findings will add to our robust body of evidence evaluating the potential for MCEDs to change the future of cancer detection, particularly in diverse populations. Medicare will cover the costs of Galleri and related and routine items and services for study participants.
Our clinical trial recruitment strategies are specifically designed to reach diverse and underrepresented populations. For example, we are partnering with medical centers and clinics in both rural and urban settings to recruit individuals with a representation consistent with the latest US census data in the PATHFINDER 2 study; the NHS-Galleri study includes enrollment centers in areas of high deprivation index and ethnicity mix in England; and the Galleri-Medicare real-world study is designed to include Medicare participants from underrepresented populations across race, ethnicity, socioeconomic status and underserved communities.
We are building our pipeline
Our proprietary targeted methylation platform, as well as our growing body of clinical and real-world data, provide us with unique insights into cancer biology that enable development of products beyond asymptomatic screening. We are developing our precision oncology portfolio and launched our research use only (RUO) technology solution, which couples our proprietary targeted methylation platform with customizable machine learning classifiers. We have partnered with a number of leading oncology therapeutics companies, and we shared our first lung adenocarcinoma data in collaboration with our partner AstraZeneca in December at the IASLC North America Conference On Lung Cancer. Some of our partnerships also include development of customized applications to support clinical studies and companion diagnostic development and commercialization.
In 2023, we published data from the SYMPLIFY study, demonstrating that our methylation platform was able to detect many cancer types and identify where the cancer signal origin was located in the body with high accuracy in a symptomatic patient population. Based on these findings, we are developing our diagnostic aid for cancer (DAC) test to accelerate diagnostic resolution for patients with non-specific signs and symptoms, but with a clinical suspicion of cancer. Through a blood test, DAC is designed to provide physicians with a powerful decision-making tool to aid diagnosis, achieve resolution more quickly, and avoid unnecessary workups.
We are focused on MCED access
GRAIL is committed to broad and equitable access to our technology to help address healthcare disparities and improve clinical outcomes. By partnering with the healthcare community and its stakeholders, we are advancing the education of diverse and medically underserved communities about the importance of early cancer detection and supporting equitable access to our technology.
In addition to our clinical development program, GRAIL is pursuing innovative partnerships to improve cancer early detection rates for underserved populations, such as our partnerships with Ochsner Health, Whitman-Walker Institute and Cancer Support Community, and the U.S. Department of Veterans Affairs (VA) Veterans Health Administration and the Veterans Health Foundation.
We are building a strong culture and team
We have built a multi-disciplinary organization of leading scientists, engineers, clinicians and other talented professionals driven to improve outcomes for patients with cancer. We believe our mission, values, and leadership attributes all contribute to this vibrant and inclusive culture and serve as a powerful magnet for talent.
GRAIL was named on Fortune’s 2023 Change the World List, which recognizes companies addressing society’s biggest challenges and having a positive social impact, and Galleri was recognized with a 2023 Edison Award, one of the highest accolades a company can receive in the name of innovation. GRAIL was also voted a Best Place to Work by several organizations, including BuiltIn and Comparably.
These achievements and accolades are only possible through the passion and commitment of our team. Pursuing scientific breakthroughs, scaling for growth and driving change across a dynamic environment requires that our team think big, bring an open mind, be courageous, solve problems together, and embrace change. Coupled with our mission, these core values provide the framework for how we work with each other, our commercial and research partners, healthcare providers, governments and others to drive the field forward and ultimately improve public health. I am grateful to our employees for their commitment to GRAIL and our mission every day.
We anticipate that 2024 will be another transformative year as we expect to complete participant visits for the NHS-Galleri study, initiate the Galleri-Medicare study, further our innovative research, and continue to drive access to Galleri and advance our commercial and research partnerships. Looking beyond, we are focused on clear strategic goals including seeking Galleri FDA approval, pursuing CMS coverage and broad commercial reimbursement for Galleri, and launching additional products.
On behalf of GRAIL’s leadership team and employees, we thank you for your continued support of our efforts to advance our mission to detect cancer early, when it can be cured.