Freenome Research Underscores Clinical Utility of Screening Tests That Detect Adenomas

Research finds adenoma detection reduces mortality in colorectal cancer regardless of adherence and implementation scenarios

SOUTH SAN FRANCISCO, May 25, 2022 — Freenome, a privately held biotech company, presented findings 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 CRC mortality reduction, among a Medicare-aged population across a range of adherence levels, test intervals and screening stop ages.

In 2021, CMS issued an NCD establishing the specificity (≥90%) and CRC sensitivity (≥74%) required for coverage of an FDA-authorized, blood-based CRC screening test. CMS did not specify any performance requirements for adenoma sensitivity.

Using Freenome’s validated model, CRC-MAPS, researchers examined the impact of increased adenoma sensitivity for two hypothetical triennial blood-based CRC screening tests. Both hypothetical tests were benchmarked to the CMS performance targets for specificity and CRC sensitivity:

  • A baseline test that assumed an all-size adenoma sensitivity informed by the NCD performance requirements, and
  • An alternative test that assumed increased size-specific adenoma sensitivities

The results demonstrated that all strategies using a test with increased adenoma sensitivity dominated the CMS benchmark test, illustrating the importance of increased adenoma sensitivity across adherence and implementation scenarios.

“This research shows that increasing adenoma sensitivity in a blood-based CRC screening test can reduce CRC incidence and improve mortality reduction,” said study coauthor, Girish Putcha, M.D., PhD, and senior vice president at Freenome. “Stated simply, adenoma detection 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 standard blood draw.

Freenome recently announced the completion of enrollment for PREEMPT CRC with more than 35,000 completed subjects, the company’s large, prospective registrational study to validate its blood test for CRC screening among average-risk adults. In addition, the company launched its first prospective clinical study for the early detection of multiple cancers using the same multiomics platform.

About Freenome

Freenome is a biotechnology company with a comprehensive multiomics platform for the early detection of cancer using a standard blood draw. The company combines its deep expertise in molecular biology with advanced computational biology and machine learning to detect disease-associated patterns among billions of circulating cell-free biomarkers. Freenome is headquartered in South San Francisco, California.