Friday Five: Freenome's CRC Test Wins FDA Nod

Freenome's blood-based colorectal cancer screening test, SimpleScreen CRC, has been approved by the U.S. Food and Drug Administration for adults aged 45 and older at average risk, marking Freenome's first commercial product and enabling Medicare coverage and inclusion in American Cancer Society guidelines.

Abbott will exclusively market SimpleScreen CRC in the U.S. starting in fall 2026, promoting it alongside its Cologuard stool test, while Freenome will receive a $100 million milestone payment tied to FDA approval under a commercialization deal signed in 2025.

The FDA approval is based on the PREEMPT CRC study of over 48,000 adults, showing 81.1% sensitivity for detecting colorectal cancer and 13.7% sensitivity for advanced precancerous lesions, with 90.4% specificity for advanced colorectal neoplasia.

Hims & Hers is facing scrutiny from the Federal Trade Commission and several states, including California and Utah, over allegations of sharing sensitive health data with third-party advertising platforms despite claims of privacy and misleading billing and cancellation practices, with the FTC filing a lawsuit on July 29, 2026.

GSK has committed $110 million to back an AI initiative in drug discovery, leveraging machine learning to accelerate development of new treatments, reflecting a broader trend of pharma companies investing in AI to enhance R&D efficiency and pipeline innovation.