# FDA approves Freenome's SimpleScreen CRC blood test; Abbott to market it in the US

Canonical page: https://technooptimist.io/stories/fda-approves-freenome-s-simplescreen-crc-blood-test-abbott-to-market-it-65f898d2
Date: 27 Jul 2026
About: [Freenome](https://technooptimist.io/companies/freenome.md) · [SimpleScreen CRC](https://technooptimist.io/biotech/simplescreen-crc.md)
Original source: https://medtechdive.com/news/freenome-secures-fda-nod-for-blood-based-colorectal-cancer-test/826290

The FDA approved SimpleScreen CRC for average-risk adults aged 45 and older, making it the second blood-based colorectal screening test after Guardant Health's Shield. Abbott, which bought Exact Sciences for $21 billion, will sell it exclusively in the US from this autumn, pairing it with Cologuard. The approval triggers a $100M milestone to Freenome.

## Key facts

- Detects about 8 in 10 colorectal cancers; about 9 in 10 people without cancer or advanced lesions test negative.
- Based on PREEMPT CRC, with more than 48,000 participants.
- Freenome went public on Nasdaq earlier in July 2026.

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