Noninvasive Testing and the Colorectal Cancer Screening Gap, With Mark Fendrick, MD

On July 27, 2026, the US Food and Drug Administration approved a new blood-based screening test for colorectal cancer (CRC), Freenome’s SimpleScreen CRC, adding another noninvasive option to the testing armamentarium.

In an interview with Patient Care Online, A. Mark Fendrick, MD, director of the University of Michigan Center for Value-Based Insurance Design and professor of internal medicine at the University of Michigan, discussed what the addition means for practice, particularly for primary care clinicians managing large panels of overdue patients.

Blood-Based Testing Gives Primary Care Another Entry Point

Fendrick said primary care clinicians are overwhelmed for many reasons beyond CRC screening, and any tool making a quality metric easier to hit is welcome. A pair of pressures are converging: guidelines lowering the age of screening initiation from 50 to 45 have added roughly 20 million average-risk adults to the eligible population, and practices are still working through a colonoscopy backlog dating back to the COVID-19 pandemic.

"The good news is we could do initial screening on a lot more people, particularly if we weren't continuing to push colonoscopy as the only preferred method," Fendrick said.

Fendrick was direct about what happens after a positive result on any noninvasive test: "It's unbelievably imperative for primary care clinicians to talk about the patients who do test positive on these non-colonoscopic initial tests," he said. "Colonoscopy is mandatory."

He said he would rather see an unscreened patient than a patient who screened positive and could not, or would not, get a follow-up colonoscopy. Fendrick called this concept "pre-commitment," urging clinicians to tell patients upfront, before they choose a noninvasive test, there is a small but real chance a positive result will still lead to colonoscopy.

Closing the Colorectal Cancer Screening-Eligible Gap

Fendrick has published on the gap between the screening-eligible population and the patients who actually get screened. The real challenge, he explained, is screening the estimated 60 million Americans currently due for CRC screening while making sure patients who test positive on a noninvasive test actually complete the screening cascade.

Fendrick said his modeling work points to one answer: shifting significantly more initial screening to noninvasive tests and reserving colonoscopy slots previously used for routine screening for patients who test positive. He likened this to an airport pre-check line, prioritizing high-risk individuals so they move through colonoscopy quickly once they screen positive on a noninvasive test.

According to Fendrick, expanding noninvasive options, blood-based or stool-based, only closes the screening gap if positive results reliably lead to colonoscopy. Without it, he suggested, a new test simply reshuffles who gets screened rather than reaching the millions still missing from the screening rolls.

Editors’ note: Fendrick reports relevant disclosures with AbbVie, Exact Sciences, Johnson & Johnson, Medtronic, Merck and Company, Phathom Pharmaceuticals, and others.

References

1. Brooks A. FDA Approves SimpleScreen CRC Blood Test for Colorectal Cancer Screening. July 27, 2026. Accessed July 27, 2026. https://www.patientcareonline.com/view/fda-approves-simplescreen-crc-blood-test-for-colorectal-cancer-screening

2. Fendrick AM, Kurlander JE, Vahdat V, et al. Optimizing Colonoscopy Capacity to Maximize Colorectal Cancer Outcomes. Gastro Hep Adv. 2026;5(5):100930. Published 2026 Mar 19. doi:10.1016/j.gastha.2026.100930