GRAIL is leading the way with a blood-based multi-cancer early detection test
December 2020/January 2021
For 45 years, the American Society of Clinical Oncology (ASCO) Annual Meeting has provided an opportunity to chart progress in the fight against cancer. Marked in its early days by steady advancements in chemotherapy and a growing understanding of cancer as a disease of the genome, in recent decades the meetings have witnessed the dramatic emergence of targeted treatments and immunotherapies. Yet despite the tremendous advancements made in oncology, more than 1,600 people die in the U.S.every single day, and cancer is soon to be the world’s number one killer. A “new front” in the war on cancer has been summoned — multi-cancer early detection.
At ASCO 2019, data was presented on the foundational study from GRAIL, the Circulating Cell-free Genome Atlas (CCGA) Study, which explains the basis for a groundbreaking development in cancer control. This is the largest study of its kind, grounded in the principles of precision medicine and leveraging technological advance in genomics and machine learning. GRAIL reported results from CCGA, demonstrating that a single blood test can detect more than 50 cancers.
The ASCO presentation was a major milestone because it suggested our test could enable the routine identification of many more cancers, and at early stages, when therapies are much more likely to be successful and even curative. For example, a person whose cancer is found before it has spread to other parts of the body is more than four times as likely to survive five years than a person diagnosed with advanced disease. 1
The unmet need for early cancer detection is significant. In fact, the five cancers with existing screening recommendations in the U.S.today represent less than 50 percent of the cancers in individuals 50 to 79 years of age. 1 And while current screening critically improves cancer outcomes, it alone is not enough. According to our estimates, nearly 71 percent of cancer deaths are attributable to cancers with no recommended screening tests. 2,3
Fortunately, there are companies and institutions making tremendous progress in the rapidly emerging technology of multi-cancer early detection. The Galleri TM multi-cancer early detection test from GRAIL was designed to maximize population cancer detection while minimizing potential harms, and is a complement to existing screening tests. The Galleri test can detect more than 50 cancers across all stages, with a very low false-positive rate of less than one percent. When a cancer signal is detected, the Galleri test can identify where in the body the cancer is located with high accuracy — critical to enable health care providers to direct efficient work-up and subsequent care for patients. Recent modeling data suggests if all cancers currently diagnosed at stage IV could be detected earlier, evenly distributed across stages I-III, cancer deaths could fall by 24 percent. 4
GRAIL is building the foundation of evidence necessary for clinical use and broad adoption. In the last year, in addition to multiple data presentations, GRAIL has published validation data for their technology in Annals of Oncology, and they initiated PATHFINDER, an interventional study that will use the Galleri test to guide clinical care for the first time. This large-scale interventional study is being conducted at Dana-Farber Cancer Institute, Mayo Clinic, Intermountain Healthcare, Sutter Health, Oregon Health & Science University, and Cleveland Clinic.
GRAIL was founded to tackle one of the most ambitious undertakings in healthcare, to find cancer early, when it can be cured. This groundbreaking technology will be the first of its kind and is set out to change the trajectory of cancer care. Beating cancer starts with knowing you have it, and this novel approach from GRAIL of early detection could provide a potent new weapon in the war against cancer.
To learn more about the Galleri multi-cancer early detection test, visit galleri.com.
1 Surveillance, Epidemiology, and End Results (SEER) Program (www.seer.cancer.gov) SEER*Stat Database: Incidence – SEER 18 Regs Research Data, Nov 2018 Sub. Includes persons aged 50-79
diagnosed 2006-2015 “Early/Localized” includes invasive localized tumors that have not spread beyond organ of origin, “Late/Metastasized” includes invasive cancers that have metastasized beyond the organ of origin to other parts of the body.
2 Among individuals 50-79 years old.
3 Assumes screening is available for all prostate, breast, cervical, and colorectal cancer cases and 33% of lung cancer cases (based on estimated proportion of lung cancers that occur in screen-eligible individuals older than 40 years) Data on file from Surveillance, Epidemiology, and End Results (SEER) 18 Regs Research Data, Nov 2017 Submission. Includes persons aged 50-79. Estimated deaths per year in
2020 from American Cancer Society Cancer Facts and Figures 2020. Available at: http://www.cancer.org/content/dam/cancer-org/research/cancer-facts-and-statistics/annual-cancer-facts-andfigures/
4” within 5 years”. The citation is as follows: Clarke CA et al. Cancer Epidemiol Biomarkers Prev. 2020;29(5):895-902.
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