Freenome, Inc. Common stock

Abbott announced the U.S. commercial launch of SimpleScreen CRC, an FDA-approved blood-based colorectal cancer screening test for adults age 45 and older at average risk for the disease. Developed and manufactured by Freenome and exclusively commercialized by Abbott, SimpleScreen CRC joins the Cologuard Plus test in Abbott's colorectal cancer screening portfolio, giving healthcare providers both stool- and blood-based options. The test was evaluated in PREEMPT CRC, the largest prospective clinical validation study for a blood-based colorectal cancer screening test, which enrolled more than 48,000 asymptomatic, average-risk adults ages 45 to 85. In a prespecified analysis adjusted to match the U.S. Census, SimpleScreen CRC demonstrated 81.1% overall sensitivity for colorectal cancer, including 63.5% sensitivity for Stage I CRC, 13.7% sensitivity for advanced precancerous lesions, and 90.4% specificity for advanced colorectal neoplasia. SimpleScreen CRC is covered by Medicare, with no out-of-pocket costs for eligible patients with Medicare Part B, while Medicare Advantage patients may have out-of-pocket costs.

The U.S. Food and Drug Administration has approved Freenome's SimpleScreen CRC, a blood-based screening test for colorectal cancer in adults 45 and older at average risk, with Abbott set to exclusively commercialize the test in the U.S. this fall. The approval triggers a $100 million milestone payment from Abbott to Freenome under their August 2025 commercial agreement. In the PREEMPT CRC study, the largest prospective validation study for a blood-based colorectal cancer screening test, SimpleScreen CRC demonstrated 81.1% sensitivity for colorectal cancer and 90.4% specificity for advanced colorectal neoplasia. The test meets Medicare coverage criteria and is expected to be incorporated into American Cancer Society guidelines by name, expanding access for up to 60 million Americans who are overdue for screening. Freenome plans to include SimpleScreen CRC in its broader SimpleScreen portfolio while advancing additional single- and multi-cancer tests on the same multiomics platform.