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Biomerica announces the Launch of InFoods IBS as a Laboratory Developed Test (LDT); First patient samples have been processed
InFoods® IBS LDT validation testing at the CLIA Lab is completed and the product is now being offered commerciallyClinical trial data shows InFoods® IBS
About this update from Biomerica, Inc.
[{"type":"text","content":"InFoods® IBS LDT validation testing at the CLIA Lab is completed and the product is now being offered commerciallyClinical trial data shows InFoods® IBS treatment diet significantly improved several key IBS symptoms including Abdominal Pain Intensity (API)The improvement in API for patients in the treatment arm versus the placebo arm was similar to, and in some cases better than, the current IBS drugs in the market. IRVINE, Calif., March 08, 2023 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA) (the “Company”) today announced the launch of its InFoods® IBS test. The test is being performed in a CLIA-certified, and CAP accredited high-complexity laboratory facility and offered as a laboratory developed test (LDT). The Company further announced all validation testing necessary for the InFoods IBS product to be offered as an LDT has been completed. The first patient samples have been processed. Following the successful completion and positive results from the Company’s InFoods IBS clinical trial (run at several prominent centers including Mayo Clinic, Beth Israel Deaconess Medical Center Inc. - a Harvard Medical School Teaching Hospital, Houston Methodist Hospital, and the University of Michigan), Biomerica has received significant interest from Gastroenterology (GI) physicians who would like to order the InFoods IBS test for their patients immediately. In the data presented at the ACG annual meeting for the Abdominal Pain Intensity (API) responder endpoint of >30% improvement in pain, patients with IBS Constipation and IBS Mixed in the treatment diet arm had a statistically significant improvement over patients in the placebo diet arm (p-value of 0.0246). The improvement for patients in the treatment arm versus the placebo arm is considered clinically significant and is similar and, in some cases, better than the current drugs in the market. Rather than simply treating the symptoms of IBS, the InFoods® IBS platform is designed to identify the unique foods that trigger or worsen IBS symptoms in individual patients, paving the way for more effective treatment. It is estimated that over 40 million Americans suffer from IBS, with symptoms often triggered by consumption of specific foods (which are unique in each sufferer). The total direct and indirect cost of IBS has been estimated at $30 billion annually in the United States alone...