An unexpected discovery unlocks a major breakthrough for changing lives at population scale
An Unexpected Discovery
2015-2017
We didn’t start off looking for a way to detect cancer.
In 2015, Illumina’s non-invasive prenatal test (NIPT) unexpectedly detected genomic abnormalities in pregnant mothers that were unrelated to the health of their children. The test detected cell-free DNA from cancer present in the mother’s blood.
In 2016, Illumina spun out a separate entity to focus on researching this incredible discovery, naming it GRAIL because the co-founders believed a simple blood test could be the “holy GRAIL” of cancer detection. With a focus on scientific excellence, transparency, and a vision for what was possible, we raised the funds required to pursue this revolutionary idea.
- July: Journal of the American Medical Association (JAMA) publishes discovery of cancer signals found in the blood of asymptomatic women
- January: GRAIL is founded
- December: GRAIL announces Circulating Cell-free Genome Atlas (CCGA) study as foundation for development of blood test to detect cancer early
- March: $1B Series B funding announced after initial $100M Series A. GRAIL acquires Cirina and key methylation IP
- April: GRAIL initiates the STRIVE study to advance development of blood tests to detect cancer early
A Major Breakthrough
2018-2019
We saw new possibilities, and dared ourselves to pursue a bold vision.
How can one breakthrough unlock others? Through research and early clinical data, we learned to pivot our focus from screening for individual cancers to screening for multiple cancers, pioneering the multi-cancer early detection (MCED) category.
This inspired an even greater sense of urgency to build the foundation for gathering and sharing clinical study data. To pursue our mission of detecting cancer early, when it can be cured, we scaled our operations, expanded to the UK, and assembled the team that would elevate GRAIL to the next level.
- July: At the American Association for Cancer Research (AACR) GRAIL presents data supporting multi-cancer early detection
- December: GRAIL announces plans to initiate SUMMIT study to support development of blood test for early cancer detection
- May: GRAIL earns Breakthrough Device Designation from FDA for MCED test
- May: $300M in Series C funding announced.
- May, June, October: Circulating Cell-free Genome Atlas (CCGA) Study data presented to the scientific community.
Life Changing Advances
2020-2021
We saw how our work could change the cancer continuum.
We expanded our clinical capabilities by building a presence in Research Triangle Park (RTP), NC. We announced a partnership with the UK government to broaden our global impact.
We announced collaborations with leading pharmaceutical companies and began testing Post-Diagnosis (PDx) and Diagnostic Aid for Cancer (DAC) models. We celebrated the commercial launch of Galleri®, the first-of-its-kind multi-cancer early detection test.
- February: PATHFINDER study begins enrolling to evaluate MCED test in clinical practice
- March: The Annals of Oncology publishes validation data showing an MCED test detects a signal shared by 50+ cancers
- May: $390M in Series D funding announced
- November: GRAIL partners with UK’s National Health Service
- December: A manuscript published in Cancer Epidemiology, Biomarkers & Prevention models the MCED test showing a reduction in late-stage diagnoses by more than half
- March: GRAIL announces Providence as first healthcare system to offer Galleri
- June: the Galleri test is launched, available by prescription in the US
- August: Illumina’s acquisition of GRAIL announced
- September: NHS launches UK trial of the Galleri test
2022 – 2023
As we scaled, we kept patients as our top priority. We shifted our focus to the audacious goal of redefining the status quo of cancer detection, which requires broad-scale engagement with the healthcare ecosystem—from patients and providers to partners and payers.
We pursued partnerships to improve cancer detection rates for underserved populations and those at higher risk for cancer, such as veterans. We navigated political and regulatory landscapes, and made progress in our mission by attracting talent, partners, and customers committed to creating a better tomorrow.
- May: GRAIL announces collaboration with U.S. Department of Veterans Affairs and the Veterans Health Foundation to evaluate the Galleri test.
- June: GRAIL announces strategic collaboration with AstraZeneca to develop companion diagnostic tests to enable the treatment of early-stage cancer.
- July: GRAIL and National Health Service (NHS) England complete enrollment of 140,000 participants in largest study of multi-cancer early detection test in just over ten months.
- September: GRAIL announces final results from the PATHFINDER Multi-Cancer Early Detection Screening Study at ESMO Congress 2022.
- September: John Hancock becomes first life insurance carrier to offer access to GRAIL’s multi-cancer early detection test to customers.
- November: CCGA discovery results published in Cancer Cell reveal methylation as promising DNA hallmark for multi-cancer early detection.
- January: GRAIL introduces state-of-the-art methylation-based solution to accelerate cancer research in the post-diagnosis setting
- June: SYMPLIFY results presented at the American Society of Clinical Oncology Conference, showing promise as Diagnostic Aid for Cancer.
- June: The Lancet Oncology publishes results from SYMPLIFY, the first prospective study of a multi-cancer early detection test in a symptomatic patient population
- June: GRAIL announces 100,000 commercial Galleri test reports delivered to patients
- August: Whitman-Walker Institute, Cancer Support Community and GRAIL collaborate on research aimed at advancing health equity in cancer screening and care through multi-cancer early detection
- October: Final results from PATHFINDER study of GRAIL’s multi-cancer early detection blood test published in The Lancet.
- November: GRAIL to initiate REACH study to evaluate clinical impact of Galleri® multi-cancer early detection test among the Medicare population
Continued Momentum
2024 and beyond
We are building what’s next in cancer detection.
In 2024 we expanded access, deepened clinical research, and prepared for our next chapter as an independent, publicly traded company. As part of our commitment to innovation and equity, we advanced strategic partnerships, added new tools to our platform, and built the operational foundation to scale. With meaningful results from two major registrational studies, we’re advancing toward our goal of changing how – and when – cancer is detected.
- January: BeniComp adds GRAIL’s multi-cancer early detection test as part of employee health screening benefits
- February: Curative Insurance Company adds the Galleri® test to health plan benefits with no out-of-pocket cost for members*
- March: GRAIL announces a novel risk classification test to be used in lung cancer study in collaboration with AstraZeneca
- March: GRAIL presents new findings on repeat screening with the Galleri® test and its methylation platform at the AACR Annual Meeting
- June: Illumina Board of Directors approves spin-off of GRAIL; company begins trading on Nasdaq under the symbol “GRAL”
- July: First participant enrolled in the REACH study evaluating the clinical impact of the Galleri® test in diverse and underrepresented groups in the Medicare population
- August: JCO Precision Oncology publishes new data on the Galleri® test performance in individuals with prostate cancer
- October: Initial results from the REFLECTION study presented at the Early Detection of Cancer Conference; participants include veterans with toxic exposure
- November: GRAIL reports commercial delivery of more than 250,000 Galleri® tests since launch
What’s next?
We’re focused on reaching more patients around the globe and providing transformative solutions across the entire cancer continuum, from screening and detection to risk stratification, biomarker subtyping, treatment, and recurrence monitoring.