FDA approves Freenome SimpleScreen CRC blood test

The U.S. Food and Drug Administration has granted approval to Freenome's SimpleScreen CRC, marking the second blood‑based screening test for colorectal cancer. The test is intended for average‑risk adults aged 45 and older and will be exclusively commercialized in the United States by Abbott later this year. Approval was based on the PREEMPT CRC study, which enrolled more than 48,000 asymptomatic participants and demonstrated the test’s clinical validity. Health‑policy expert Mark Fendrick, MD, said the new option could increase screening uptake among the roughly 60 million Americans who are overdue for colorectal cancer screening.

In the same month, gastroenterology researchers reported phase‑2b data for the TL1A antibody duvakitug, showing strong 14‑week remission rates in ulcerative colitis and clinical response in Crohn disease, highlighting ongoing advances in inflammatory‑bowel‑disease treatment.