Freenome won FDA approval for its blood-based SimpleScreen colorectal cancer test, the company said Monday, marking a new commercial milestone for cfDNA methylation analytics. The test is cleared for adults 45 and older at average risk and uses a blood draw to detect colorectal cancer-associated signals. Freenome also disclosed an Abbott commercialization agreement: Abbott will exclusively market the test starting this fall under terms that include a $100 million milestone payment to Freenome. The company said SimpleScreen is designed to address gaps in CRC screening participation, citing that tens of millions of eligible Americans remain overdue. With Medicare coverage criteria met, Freenome is positioning SimpleScreen as a complementary option alongside Abbott’s Cologuard, targeting unscreened patients who may be more willing to complete blood-based screening than stool-based collection. Independent of adoption questions, the clearance creates immediate regulatory and payer exposure for a new AI-enhanced screening pathway in CRC and sets up a near-term competitive test for next-generation liquid-biopsy-style diagnostics.