The U.S. Food and Drug Administration (FDA) has approved Freenome’s blood-based colorectal cancer screening test for older adults. This approval paves the way for partner Abbott to launch the test in the U.S. this fall.

Test Details

The test, SimpleScreen CRC, detects signals linked to colorectal cancer from DNA fragments circulating in the blood. It was evaluated in a large study that enrolled over 48,000 adults across more than 200 sites.

In the study, the test detected colorectal cancer with 81.1% sensitivity in a prespecified analysis. It also detected advanced precancerous growths with 13.7% sensitivity, including 30.7% sensitivity for high-risk precancerous growths.

With the approval, the test meets Medicare coverage criteria, while blood-based colorectal cancer screening is already included in updated American Cancer Society screening guidelines.

Freenome will receive a $100 million milestone payment from Abbott tied to the approval under the commercialization deal signed in 2025. Freenome said it plans to develop more blood-based cancer screening tests, including for lung cancer, using the same technology platform.

Colorectal cancer, which affects the colon or rectum, is the third-most common cancer diagnosed in the U.S., according to the American Cancer Society.

Original reporting: Appleton, WI News Feed (HLL/CB) — read the source article.