FDA approves another blood-based colorectal cancer test

Clinical takeaway: For average-risk patients who won't screen any other way, a blood test is better than no screening. Counsel them that it catches most cancers but few precancers, and that a positive result still requires colonoscopy.

Colorectal cancer is one of the most preventable cancers, yet up to 60 million Americans are overdue for screening. Much of that gap is behavioral due to people who won't do a colonoscopy prep or mail back a stool sample. A blood draw at a routine visit helps to address those barriers, which supports the case for adding a second blood-based screening option. But the question remains: what level of accuracy are clinicians giving up in exchange?

This disease will claim more than 55,000 US lives this year, most of them preventable through timely screening. Incidence is also rising in younger adults, which is part of why the eligible age recently dropped to 45. Yet a large share of that expanded population remains unscreened, and reaching them is the gap any new test has to close.

The test, SimpleScreen CRC, detected 81.1% of colorectal cancers in PREEMPT CRC, the largest prospective validation trial of a blood-based CRC test. It produced negative results for 90.4% of people without cancer or advanced precancer. But sensitivity for advanced precancerous lesions was only 13.7%, rising to 30.7% for the highest-risk lesions with high-grade dysplasia. In plain terms, the test catches about eight of 10 cancers but misses most of the precancer that colonoscopy is designed to remove.

PREEMPT CRC enrolled more than 48,000 asymptomatic, average-risk adults ages 45 to 85 across over 200 US sites, all scheduled for screening colonoscopy, which served as the comparator. Performance was reported from a prespecified analysis adjusted to match the US Census. The test detects colorectal cancer signals from cell-free DNA in the blood.

For a generalist, the decision is about sequencing, not just availability. Offer colonoscopy or a stool-based test first, since both do more to prevent cancer, and reserve the blood test for patients who decline them. The weak precancer detection also reframes the negative result: a normal blood test is more reassuring about existing cancer than about the polyps that become cancer later, which argues against stretching the re-screen interval.

"The most effective screening test is the one a person will actually complete," said Aasma Shaukat, MD, MPH, professor of medicine at NYU Grossman School of Medicine and a co-lead principal investigator on the PREEMPT CRC study. "Many people who should be screened for colorectal cancer simply aren't. A blood-based test provides another way to reach unscreened patients."

Source: Freenome. 2026 Jul 27. FDA Approves Freenome's SimpleScreen CRC Blood-Based Screening Test; Abbott to Commercialize in the U.S.