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

Freenome/SimpleScreen CRC

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.

• 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.