– Research finds that detecting adenomas reduces mortality in colorectal cancer, regardless of adherence and implementation scenarios
SOUTH SAN FRANCISCO, May 25, 2022 /PRNewswire/ — Freenome, a private biotechnology company, presented results at the Digestive Disease Week (DDW) annual meeting that compared hypothetical colorectal cancer (CRC) screening tests that detect adenomas to the minimum test performance requirements established by the Centers for Medicare and Medicaid Services (CMS) in their 2021 National Coverage Determination (NCD).
Overall, the research found that detecting adenomas improves clinical outcomes, such as reduced CRC mortality, among a Medicare-aged population across a range of adherence levels, intervals of testing and ages at which screening stops.
In 2021, CMS issued an NCD establishing the specificity (≥90%) and sensitivity to CRC (≥74%) required for coverage of an FDA-cleared blood-based CRC screening test. CMS has not specified performance requirements for adenoma susceptibility.
Using Freenome’s validated model, CRC-MAPS, researchers examined the impact of increased sensitivity to adenoma for two hypothetical three-year CRC blood screening tests. The two hypothetical tests were compared to the CMS performance targets for specificity and sensitivity to CRC:
- A gold standard test that assumed susceptibility to adenoma of all sizes informed by NTM performance requirements, and
- An alternative test that assumed heightened sensitivities of size-specific adenomas
Results demonstrated that all strategies using a test with increased adenoma sensitivity dominated the CMS benchmark test, illustrating the importance of increased adenoma sensitivity in adherence and implementation scenarios. .
“This research shows that increasing sensitivity to adenoma in a blood screening test for CRC can reduce the incidence of CRC and improve mortality reduction,” said study co-author, Girish Putcha, MD, PhD and Senior Vice President at Freenome. “Put simply, detecting an adenoma can save lives.”
Freenome is developing a CRC screening test using a multiomics platform, which combines both tumor and non-tumor signals with machine learning to detect CRC and advanced adenomas using a swab standard blood.
Freenome recently announcement the completion of enrollment for PREEMPT CRC with more than 35,000 subjects completed, the company’s large prospective registration study to validate its blood test for CRC screening in average-risk adults. Additionally, the company initiated its first prospective clinical study study for early detection of multiple cancers using the same multiomics platform.
Freenome is a biotechnology company with a comprehensive multi-omics platform for early detection of cancer using standard blood sampling. The company combines its deep expertise in molecular biology with advanced computational biology and machine learning to detect disease-associated patterns among billions of cell-free circulating biomarkers. Freenome is headquartered in South of San Francisco, California.
SOURCEFreenome Holdings, Inc.