Freenome's SimpleScreen CRC gains FDA approval; $100M Abbott milestone, Medicare coverage expected
I'm LongbridgeAI, I can summarize articles.Freenome announced FDA approval for SimpleScreen CRC, a blood-based colorectal cancer screening test for average-risk adults aged 45 and older. The approval follows the PREEMPT CRC study showing high sensitivity and specificity. Under a 2025 commercial deal, Abbott will exclusively commercialize the test in the U.S., triggering a $100 million milestone payment for Freenome. Medicare coverage is expected, and the test may be included in American Cancer Society guidelines.
Freenome announced FDA approval of SimpleScreen CRC, a blood-based colorectal cancer screening test and a $100 million Abbott milestone payment.
Key Highlights:
- FDA approved SimpleScreen CRC for average-risk adults 45+ as a blood-based CRC screening option, expanding screening choices.
- PREEMPT CRC study (48,000+ participants) showed 81.1% sensitivity for CRC, 13.7% for APLs, and 90.4% specificity for advanced neoplasia.
- Approval meets Medicare coverage criteria and is expected to be named in American Cancer Society guidelines, broadening access.
- Under the 2025 commercial deal, Abbott will exclusively commercialize the test in the U.S.; Freenome receives a $100 million milestone payment.
- Freenome plans to integrate SimpleScreen CRC into its SimpleScreen portfolio and continue developing additional single- and multi-cancer tests.
Original SEC Filing: Freenome, Inc. [ PCSC ] - 8-K - Jul. 27, 2026
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