MANY MINDEDBlood test for colon cancer clears FDA, headed to market via Abbott
The FDA approved Freenome's SimpleScreen CRC, a blood-based test for colorectal cancer, which Abbott will exclusively market in the US under a 2025 deal that pays Freenome $100 million. The test is for average-risk adults aged 45 and older. Colorectal cancer is the second-leading cause of cancer death in the US.
SimpleScreen detects signals in cell-free DNA circulating in the blood. In a prespecified analysis adjusted to the US population, it showed 81.1% sensitivity for colorectal cancer and 90.4% specificity for advanced colorectal neoplasia. It was far weaker at catching precancer: 13.7% sensitivity for advanced precancerous lesions and 30.7% for lesions with high-grade dysplasia. Aasma Shaukat of NYU Grossman School of Medicine co-led the supporting study. The test competes with Guardant Health's Shield, approved in 2024, while Abbott also markets the Cologuard stool test.
A blood draw is far easier to get people to accept than a colonoscopy or a stool test. Freenome estimates up to 60 million Americans are overdue for recommended screening, so a low-friction option that catches most cancers could pull people into screening who otherwise skip it entirely, widening access to early detection.
The honest limit is in the numbers: blood tests are less sensitive than stool tests and visual exams, especially for precancerous growths that colonoscopy can remove. The American Cancer Society recommends blood-based screening only for people who decline preferred options. Watch whether Medicare coverage and guideline inclusion follow, both of which are currently Freenome's assertions.
Source: Fierce Biotech