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New Blood Test Detects Colorectal Cancer
29 Jul
Summary
- FDA approved Freenome's blood test for colorectal cancer screening.
- The test detects DNA fragments linked to cancer in blood.
- Abbott will commercialize the test in the U.S. this fall.
The U.S. Food and Drug Administration has granted approval for Freenome's blood-based colorectal cancer screening test. This significant milestone allows for the commercial launch of Freenome's first product, SimpleScreen CRC, in the U.S. this fall through a partnership with Abbott. The test is designed for average-risk adults aged 45 and older.
SimpleScreen CRC functions by identifying DNA fragments connected to colorectal cancer that are present in the bloodstream. Its efficacy was demonstrated in a large-scale study involving over 48,000 participants across more than 200 sites. The study showed the test detected colorectal cancer with 81.1% sensitivity.
With this FDA approval, the test meets Medicare coverage criteria and aligns with updated American Cancer Society screening guidelines. Freenome is set to receive a $100 million milestone payment from Abbott. The company also plans to leverage its technology platform for developing additional blood-based cancer screening tests, including for lung cancer.
