Gastroenterology in July 2026: FDA approves Freenome's SimpleScreen CRC blood test, plus new duvakitug data in UC and Crohn disease.
July brought a milestone US Food and Drug Administration (FDA) approval in colorectal cancer (CRC) screening and fresh phase 2b data in inflammatory bowel disease (IBD), both with real implications for gastroenterology and primary care practice.
Freenome's SimpleScreen CRC became only the second FDA-approved blood-based screening test for colorectal cancer, offering a new noninvasive option for the roughly 60 million Americans who remain overdue for screening.HCPLive also spoke with health policy expert Mark Fendrick, MD, about what the approval could mean for screening uptake and access in practice.
Meanwhile, new phase 2b RELIEVE UCCD data showed the TL1A antibody duvakitug driving strong 14-week clinical remission rates in ulcerative colitis (UC) and clinical response in Crohn disease (CD), adding to a fast-growing pipeline of TL1A-targeted therapies in IBD.
Here's a closer look at the July 2026 stories shaping gastroenterology practice, a landmark screening approval, promising IBD trial results, and expert insight on what comes next.
FDA Approves Freenome Blood Test for Colorectal Cancer Screening
On July 27, 2026, the FDA approved Freenome's SimpleScreen CRC, a blood-based screening test for colorectal cancer in average-risk adults aged 45 years and older, giving clinicians a second FDA-approved blood-based screening option. The approval was supported by the PREEMPT CRC study, the largest prospective clinical validation study conducted for a blood-based CRC screening test, which enrolled more than 48,000 asymptomatic, average-risk adults. Abbott will exclusively commercialize the test in the US beginning this fall.
TL1A Antibody Duvakitug Boosts Clinical Remission in UC, Response in CD
Newly published phase 2b RELIEVE UCCD data showed strong 14-week results for the TL1A antibody duvakitug in both ulcerative colitis and Crohn disease, with meaningful rates of clinical remission in UC and clinical response in CD, reinforcing TL1A inhibition as one of the more closely watched mechanisms in the current IBD pipeline.
In this interview, Mark Fendrick, MD, discusses the FDA approval of the SimpleScreen CRC blood test and what it could mean for expanding colorectal cancer screening access. The conversation covers how a simple blood draw option could reach patients who have been unwilling or unable to complete stool-based tests or colonoscopy, and what this means for closing the screening gap among the tens of millions of Americans currently overdue.