Freenome said the FDA approved its SimpleScreen CRC, a blood-based colorectal cancer screening test built on cell-free DNA signals. The company, which launched publicly last week, will rely on Abbott for exclusive commercialization starting this fall. SimpleScreen is indicated for adults age 45 and older at average risk and uses a simple blood draw. Freenome reported that the test detects signals associated with colorectal cancer from cfDNA, aligning with the company’s PRE-EMPT CRC registrational study approach. Under the Abbott deal, Freenome expects a $100 million milestone tied to regulatory approval and expansion of screening capacity—an important competitive development as blood-based CRC testing continues to move into clinical workflows and coverage criteria.
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