Advancements in Noninvasive Colorectal Cancer Screening, with Fola May, MD, PhD

With rates of colorectal cancer on the rise in younger adults and screening adherence rates lagging, the push for more accessible, less invasive options is at an all-time high. Today, patients have more choices than ever—from traditional colonoscopy to at-home stool tests and, most recently, blood-based screening.

“One of the biggest benefits we have in colorectal cancer screening is that we have multiple screening options,” Fola May, MD, PhD, an associate professor at the David Geffen School of Medicine and associate director of the UCLA Kaiser Permanente Center for Health Equity, explained to HCPLive, describing the different noninvasive tests currently available to patients who are unable or unwilling to undergo colonoscopy.

In 2024, the FDA approved Exact Sciences’ Cologuard Plus test, the company’s next-generation multitarget stool DNA test, and Geneoscopy’s ColoSense, a noninvasive multi-target stool RNA colorectal cancer screening test, for adults ≥ 45 years of age at average risk of developing colorectal cancer.1,2

The latest development in noninvasive colorectal cancer screening is the emergence of blood-based tests. In July 2024, the FDA approved Guardant Health’s Shield blood test for primary colorectal cancer screening in average risk adults ≥ 45 years of age.3

“There’s only one of these that’s currently FDA approved, but there’s many of them that will be coming on the market soon,” May said.

Even with the availability of several noninvasive tests, colonoscopy continues to be viewed as the “gold standard” because it allows for real-time visualization of the colon and enables immediate removal of polyps during the procedure, offering both diagnostic and therapeutic benefits.

May notes that this process is slightly different for NITs, which involve a 2-step process: a positive result means the patient must then undergo a colonoscopy, something she says clinicians must communicate to their patients to ensure they know they are signing up for a colonoscopy if their noninvasive test comes back abnormal.

“I think many of us are very curious to see where [blood-based tests] fall,” May said. “Right now, I would say that the majority of physicians are still recommending that patients go ahead and pursue either a colonoscopy or one of these noninvasive test options I mentioned, either an FIT test, an FIT DNA test, or a CT colonography.”

However, she says blood-based tests are increasingly being used in patients who have historically been nonadherent to other screening options, as this provides them with an option they may view as easier or more convenient. As more data emerge and guidelines evolve, May notes the role of blood-based testing in colorectal cancer screening could expand.

Editors’ note: May has relevant disclosures with Kimberly-Clark, Medtronic, Takeda, Freenome, Geneoscopy, and Exact Sciences.

References

1. Brooks A. FDA Approves Exact Sciences’ Cologuard Plus Test for Colorectal Cancer Screening. HCPLive. October 4, 2024. Accessed April 21, 2025. https://www.hcplive.com/view/fda-approves-exact-sciences-cologuard-plus-test-for-colorectal-cancer-screening

2. Campbell P. FDA Approves ColoSense, a Noninvasive mt-sRNA Test, for Adults 45 or Older. HCPLive. May 7, 2024. Accessed April 21, 2025. https://www.hcplive.com/view/fda-approves-colosense-a-noninvasive-mt-srna-test-for-adults-45-or-older

3. Brooks A. FDA Approves First Blood Test for Primary Colorectal Cancer Screening. HCPLive. July 29, 2024. Accessed April 21, 2025. https://www.hcplive.com/view/fda-approves-first-blood-test-primary-colorectal-cancer-screening