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FDA
Food and Drug Administration
- Biomerica's real-world study of 69 IBS patients demonstrated that 59.4% achieved clinically meaningful abdominal pain reduction and 68.1% experienced significant bloating relief using FDA-recognized responder endpoints. - The Centers for Medicare & Medicaid Services established a $300 national Medicare payment rate for the inFoods IBS test, effective January 1, 2026, providing reimbursement clarity for the diagnostic. - Real-world results closely mirror the company's peer-reviewed randomized controlled trial published in Gastroenterology, which showed 59.6% pain response rates across five major academic centers. - The personalized diagnostic approach targets an estimated 30-45 million IBS patients in the United States through food sensitivity testing and targeted dietary interventions.