On December 16, 2020 GRAIL, Inc., a healthcare company whose mission is to detect cancer early,reported that new analyses estimating the potential of GRAIL’s multi-cancer early detection blood test to find more cancers earlier and save lives (Press release, Grail, DEC 16, 2020, View Source [SID1234572950]).
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Published in Cancer Epidemiology, Biomarkers & Prevention, a journal of the American Association for Cancer Research (AACR) (Free AACR Whitepaper), the analysis used epidemiologic modeling to estimate the potential impact of adding an annual multi-cancer early detection blood test, such as GRAIL’s Galleri, to standard of care cancer screenings. The model estimates a potential reduction in late-stage (stage III and IV) cancer diagnoses by more than half in the U.S. population, aged 50-79. This decrease in late-stage diagnoses could translate to a reduction in five-year cancer deaths by 39% among those detected earlier, equating to an overall reduction of all five-year cancer deaths by 26%.
Today, the majority of cancers are found too late when outcomes are often fatal, because most deadly cancers have no available screening tests. Current guideline-recommended screenings are critical, but in the U.S. they cover only five cancers and screen for a single cancer at a time. Cancers responsible for nearly 71% of cancer deaths have no recommended early detection screening.
In clinical validation studies, an earlier version of Galleri demonstrated the ability to detect more than 50 types of cancers — over 45 of which lack recommended screening tests in the U.S. — with a low false positive rate of less than 1%. When a cancer was detected, the test also determined where in the body the cancer signal was located with high accuracy, all from a single blood draw.
"What we learned through this advanced modeling analysis is that GRAIL’s multi-cancer early detection test, based on identifying methylation signals in the circulating DNA, has the potential to substantially reduce overall cancer deaths," said Joshua Ofman, MD, MSHS, Chief Medical Officer and External Affairs at GRAIL. "A simple blood test like Galleri, that can detect more than 50 types of cancers and dramatically increase the cancer detection rate in the population, holds great potential to improve public health and save lives."
The cancer "interception model" — as the researchers describe it — uses published test performance data from GRAIL’s foundational Circulating Cell-free Genome Atlas (CCGA) study, including the cancer detection rate across all stages. It employs data from the U.S. Surveillance, Epidemiology, and End Results (SEER) program to quantify the stages at which cancers are currently diagnosed to understand the total number of cancers detected, and the potential reductions — or interceptions — in late-stage cancer diagnoses and associated deaths that could occur by adding GRAIL’s multi-cancer early detection test to standard of care cancer screenings in the U.S population, ages 50-79.
"Nearly all prior modeling efforts have focused on single cancer screening programs, leaving a gap in models addressing the potential population health benefits of multi-cancer early detection," said Christine D. Berg, MD, Special Volunteer, Division of Cancer Epidemiology and Genetics, National Cancer Institute, National Institutes of Health. "Nothing like GRAIL’s test exists today, making rigorous modeling our current best approach to quantify the magnitude of the potential impact this innovative genomic technology could have on people across the U.S. through earlier cancer detection."
Galleri is expected to be available in the U.S. in 2021 and is currently available under investigational use in GRAIL’s first interventional study, PATHFINDER, where it is being used to guide clinical care. Galleri is also expected to be offered to patients in the United Kingdom (UK) starting in 2021 as part of a partnership with the UK’s National Health Service to support its Long Term Plan for earlier cancer diagnoses in an effort to transform cancer outcomes.