Freenome, Inc. (FRNM), an early cancer detection company, and Abbott Laboratories (ABT) announced Monday that U.S. FDA has approved SimpleScreen CRC, a blood-based screening option for patients with Colorectal Cancer aged 45 and older who are at average risk for the disease.
According to the company, colorectal cancer is a second-leading cause of cancer-related deaths in the United States, with up to 60 million Americans remaining overdue for recommended screening.
SimpleScreen CRC is a blood-based screening test designed to detect cancer signals associated with colorectal cancer from cell-free DNA.
The approval was substantiated with positive results from the PREEMPT CRC study. In the pre-specified U.S. Census-adjusted analysis, the test demonstrated 81.1% sensitivity for detecting colorectal cancer and 90.4% specificity for advanced colorectal neoplasia. The test also detected 13.7% of advanced precancerous lesions or APLs, including 30.7% of APLs with high-grade dysplasia.
According to Freenome, the test correctly identified about 8 in 10 colorectal cancers while correctly returning negative results for 9 in 10 individuals without the indication.
Under a commercial agreement signed with Abbott in August 2025, Freenome expects to receive a $100 million as milestone payment, following the FDA approval.
Meanwhile, Abbott will exclusively commercialise SimpleScreen CRC in the U.S., leveraging its established provider network, reimbursement capabilities, and patient support infrastructure built through its Cologuard colorectal cancer screening business.
The company said with FDA approval enables SimpleScreen CRC to meet Medicare coverage criteria and is expected to lead to its inclusion in the American Cancer Society's colorectal cancer screening guidelines, expanding access to blood-based screening for eligible adults.
Additionally, Freenome plans to incorporate SimpleScreen CRC into its broader portfolio, while continuing to advance the test into multiomics platform.
FRNM is trading down 0.53% at $11.18.
ABT is trading at $105.30, up 2.17%.
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September 11, 2026 16:26 ET Consumer prices data was the main news on the economic front in the U.S. this week. In Europe, the latest interest rate decision from the European Central Bank was the focus along with the revised second quarter economic growth data for the euro area. In Asia, the monthly foreign trade data from China drew attention.