FDA approved Freenome's SimpleScreen CRC on July 24. The PMA, P250029, covers qualitative detection of colorectal cancer signals in blood from average-risk adults aged 45 and older. A positive result sends the patient to colonoscopy. FDA received the application on August 1, 2025, so the review ran 357 days. Freenome announced the decision on July 27.
The PREEMPT CRC study enrolled more than 48,000 asymptomatic adults aged 45 to 85. Sensitivity for colorectal cancer was 81.1% and specificity was 90.4%. Sensitivity for advanced precancerous lesions was 13.7%, rising to 30.7% for high-grade dysplasia. Guardant Health's Shield, approved in 2024, is the only other blood test in the category.
The money followed the letter. Abbott signed an exclusive U.S. commercialization deal in August 2025 and owes Freenome a $100M milestone on approval, with a launch planned for fall 2026. Freenome had closed its SPAC merger with Perceptive Capital Solutions days earlier. It listed on Nasdaq as FRNM on July 21 with about $310M in gross proceeds, including a $240M PIPE. Freenome keeps the rights to multi-cancer versions of the test.
Abbott also owns Cologuard after its $21B purchase of Exact Sciences. TD Cowen analysts expect it to steer SimpleScreen toward patients who refuse or fail to complete a stool test. A blood test that is second in its category and second on its own distributor's shelf is still a PMA with a $100M check attached.