USFDAJul 27, 2026, 08:16 AM
Freenome's SimpleScreen CRC Blood Test Approved by FDA; Abbott to Commercialize
AI Summary
Freenome, Inc. announced that its SimpleScreen™ CRC blood-based screening test for colorectal cancer received FDA approval. Abbott will exclusively commercialize the test in the U.S., and Freenome will receive a $100 million milestone payment from Abbott for this approval. The test is designed for adults aged 45 and older at average risk for colorectal cancer, offering a new, convenient screening option that meets Medicare coverage criteria and is expected to be included in American Cancer Society guidelines.
Key Highlights
- Freenome's SimpleScreen™ CRC blood-based screening test received FDA approval.
- Abbott will exclusively commercialize SimpleScreen CRC in the U.S.
- Freenome will receive a $100 million milestone payment from Abbott for the FDA approval.
- The test detected colorectal cancer with 81.1% sensitivity and 90.4% specificity for advanced colorectal neoplasia.
- SimpleScreen CRC is for adults 45 and older at average risk for colorectal cancer.
- The test meets Medicare coverage criteria and is expected to be incorporated into American Cancer Society guidelines.
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