Freenome’s Multiomics Blood Test Shows Promising Results in Detecting Colorectal Advanced Adenomas in a Prospective, Multi-Center Clinical Study

New results from the AI-EMERGE® study show Freenome’s multiomics blood test can detect colorectal advanced adenomas at 41% sensitivity and 90% specificity, which is comparable to or better than currently available non-invasive tests for colorectal cancer screening.

This data, to be presented at ASCO-GI, build on previously reported data from a separate cohort that showed Freenome’s multiomics blood test can detect early-stage colorectal cancer (stage I/II) at 94% sensitivity and 94% specificity.

A multiomics approach enabled detection of twice as many advanced adenomas as single assay approaches.

SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–#CRCScreeningFreenome, a privately held biotechnology company that has pioneered a comprehensive multiomics platform for early cancer detection with a routine blood draw, today announced 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’s Gastrointestinal Cancers (ASCO-GI) Symposium on January 15th, 2021.

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 https://www.freenome.com/science at the time of presentation at ASCO-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.

About Freenome

Freenome is a biotechnology company that has pioneered the most comprehensive multiomics platform for early cancer detection using a routine blood draw, beginning with a colorectal cancer screening test. The company combines its deep expertise in molecular biology with advanced computational biology and machine learning techniques to detect disease-associated patterns among billions of circulating cell-free biomarkers. Freenome is also building a machine learning feedback loop with healthcare providers to leverage real-world data and improve patient care through early detection. Freenome is headquartered in South San Francisco, California. For more information about Freenome, visit www.freenome.com and view open positions at freenome.com/careers.

1Timothy Robert Church et al., “Prospective evaluation of methylated SEPT9 in plasma for detection of asymptomatic colorectal cancer,” Gut (February, 2014)

2Thomas F. Imperiale, M.D. et al., “Multitarget Stool DNA Testing for Colorectal-Cancer Screening,” New England Journal of Medicine (April 3, 2014)

3Girish Putcha et al., “Blood-Based Detection of Early-Stage Colorectal Cancer Using Multiomics and Machine Learning,” American Society of Clinical Oncology’s Gastrointestinal Cancers Symposium (January, 2020). Available at https://www.freenome.com/bloodbased-detection-of-earlystage
4Djenaba A. Joseph, M.D. et al, “Vital Signs: Colorectal Cancer Screening Test Use — United States, 2018,” Centers for Disease Control and Prevention Morbidity and Mortality Weekly Report, (March 13, 2020)

Contacts

Allan Ng

press@freenome.com