Freenome, Inc. 8K

Freenome received FDA approval for its SimpleScreen™ CRC blood-based colorectal cancer screening test, activating a $100 million milestone from Abbott, which will exclusively commercialize the test in the U.S. with expected Medicare coverage and ACS guideline inclusion.

On July 27, 2026, Freenome, Inc. announced that the U.S. Food and Drug Administration approved its SimpleScreen™ CRC blood-based colorectal cancer screening test for average-risk adults aged 45 and older, triggering a $100 million milestone payment from Abbott under their August 2025 commercial agreement and granting Abbott exclusive U.S. commercialization rights. The approval, supported by data from the large PREEMPT CRC® validation study, positions SimpleScreen CRC for Medicare coverage and anticipated inclusion by name in American Cancer Society guidelines, broadening access to minimally invasive CRC screening and expanding Freenome’s SimpleScreen portfolio and Abbott’s colorectal cancer screening offerings alongside Cologuard®.

Filing Facts

CIK

2017526

Ticker

-

Form

8K

Source Type

sec

Accession

0001140361-26-029689

Alert Tier

7