On January 12, 2021 Freenome, a privately held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection with a routine blood draw, reported that it will be presenting results for the detection of colorectal advanced adenomas from its prospective, multi-center clinical study, AI-EMERGE, at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper)’s Gastrointestinal Cancers (ASCO-GI) Symposium on January 15th, 2021 (Press release, Freenome, JAN 12, 2021, View Source [SID1234573920]).
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The data from a pre-defined subset of AI-EMERGE (n=522) showed that Freenome’s novel multiomics blood test for colorectal cancer screening was able to detect colorectal advanced adenomas (AAs) with a sensitivity of 41% at a specificity of 90%. Compared with the FDA-approved mSEPT9 (methylated septin 9) blood test, Freenome’s multiomics blood test showed much higher sensitivity (41% vs. 22%)1 for detecting AAs. When compared to currently available stool-based tests, the test demonstrated much higher AA sensitivity than a fecal immunochemical test, or FIT (41% vs. 24%) and comparable AA sensitivity to FIT-DNA (41% vs. 42%)2.
These new results augment previously reported data, which showed that Freenome’s multiomics blood test can detect early-stage colorectal cancer (stage I/II) at a sensitivity of 94% and specificity of 94%3. A blood test with performance characteristics comparable or better than fecal tests can improve access and drive better adherence, facilitating early detection, and ultimately reducing mortality.
"The ability to detect advanced adenomas is incredibly important because we can remove them before they become cancerous," said Aasma Shaukat, M.D., M.P.H., Chief of Gastroenterology at Minneapolis VA Health Care System and Professor of Medicine, University of Minnesota. "That means with a blood test such as Freenome’s multiomics test, not only can we detect colorectal cancer, but we may be able to prevent colorectal cancer altogether."
"This data reflects significant progress in the development of blood-based cancer screening," added Carol Burke, M.D., Vice Chair of the Department of Gastroenterology, Hepatology, and Nutrition and Head of the Section of Polyposis in the Sanford R. Weiss MD Center for Hereditary Colorectal Cancer at Cleveland Clinic, Cleveland Ohio. "A blood test that can detect both advanced adenomas and early stage colorectal cancer could be an important tool in the fight against colorectal cancer."
Importantly, these new results also showed that Freenome’s multiomics blood test detected twice as many advanced adenomas as cell-free DNA methylation-only or single-protein approaches. Freenome’s multiomics blood test differs from single assay approaches because it combines signatures from both tumor- and non-tumor- (e.g., immune) derived sources.
"While tumor-derived signals are abundant in later-stage disease, signals from non-tumor sources predominate in earlier stages," said C. Jimmy Lin, MD, PhD, MHS, Chief Scientific Officer for Freenome. "That’s why we believe that our multiomics platform, which combines those signals, is critical in the development of next-generation, blood-based cancer screening."
The data and poster for the new results from the AI-EMERGE study will be available online at View Source at the time of presentation at ASCO (Free ASCO Whitepaper)-GI on January 15, 2021.
About Colorectal Cancer (CRC) and Screening
According to the U.S. Centers for Disease Control (CDC), colorectal cancer (CRC) is the second leading cause of death in the United States from cancers that affect both men and women. Both CRC incidence and mortality have declined steadily over the past 30 years, attributable in part to the increasing percentage of adults aged 50–75 years who are up to date with recommended CRC screening. However, only 68.8% of adults aged 50–75 years were up to date with CRC screening in 20184. A CDC study shows that compliance varies based on income, access to health insurance and other factors, including lack of awareness of the need to be screened, being offered colonoscopy only instead of a choice of tests, fear, expense, inability to take time off work, and the perceived undesirable nature of screening tests.