The last 12 months saw major regulatory changes for the field of gastroenterology, from new FDA approvals to sweeping statewide and national legislation.
Here is what to know about a handful of recent regulatory changes.
FDA approvals
In July, the FDA approved a new screening test for colorectal cancer that only requires a sample of blood. While met with mixed reviews from physicians and GI groups, the blood test, created by Palo Alto, Calif.-based Guardant Health, was able to detect 83% of colorectal cancers in studies, but only 13% of dangerous polyps.
In October, the FDA also approved the Cologuard Plus test, a next-generation, multitarget stool DNA test approved for patients at an average risk for colorectal cancer. The FDA's approval was based on findings from the Blue-C study, one of the largest prospective, head-to-head studies ever conducted in colorectal cancer screening. Among the 19,000 study participants, the Cologuard Plus test demonstrated 95% overall cancer sensitivity and 43% sensitivity for advanced precancerous lesions at 94% specificity.
State legislation
On Jan. 1, legislation went into effect in four states providing patients full insurance coverage for their colonoscopy procedures. Nebraska, Illinois, Vermont and Kentucky have expanded access for patients.
"This is great legislative advocacy for patients and I applaud the efforts and initiative of the Illinois General Assembly," Omar Khokhar, MD, partner at Illinois GastroHealth in Bloomington, told Becker's. "Colon cancer is preventable with early detection and anything that increases access will improve CRC-related morbidity, mortality and associated costs."
Drug approvals
In 2024, the FDA approved 50 new drugs. One of those drugs, Vyloy, approved on Oct. 18, falls under the umbrella of gastroenterology.
Vyloy is used to treat gastric or gastroesophageal junction adenocarcinoma. It is used in combination with fluoropyrimidine- and platinum-containing chemotherapy.