July 27, 2026- Freenome, Inc., an early cancer detection company developing blood-based screening tests, and Abbott announced that the U.S. Food and Drug Administration (FDA) has approved SimpleScreen™ CRC, a new blood-based screening option for colorectal cancer (CRC) in adults 45 and older who are at average risk for the disease. Abbott will exclusively commercialize the test in the U.S. this fall, expanding its CRC screening portfolio with a new option that requires only a simple blood draw.
Under the terms of the commercial agreement signed between Freenome and Abbott in August 2025, Freenome will receive a $100 million milestone payment from Abbott for this FDA approval. Abbott will exclusively commercialize SimpleScreen CRC in the U.S., building on the provider relationships, reimbursement expertise and patient support programs it has developed through Cologuard®. The company’s established CRC infrastructure – including its Nexus platform – will help connect more people to screening and support adoption across the healthcare system.
SimpleScreen CRC detects signals associated with colorectal cancer from cell-free DNA (cfDNA) in the blood. FDA approval reflects years of clinical research, AI/ML-driven technology development and extensive collaboration with investigators, healthcare providers and partners.
With FDA approval, SimpleScreen CRC meets the coverage criteria for Medicare and is expected to be incorporated into the American Cancer Society guidelines by name. Together, these milestones help expand access to blood-based CRC screening for eligible adults.
