Biomerica Inc BMRA has announced topline results from its InFoods IBS diagnostic-guided therapy (DGT) endpoint clinical trial.
- The trial showed statistically significant improvements in multiple endpoints in the Intent-to-Treat population.
- The InFoods DGT uses a simple blood test to identify patient-specific foods that may alleviate Irritable Bowel Syndrome (IBS) symptoms such as pain, bloating, diarrhea, and constipation when removed from the diet.
- Related: Biomerica's Shares Gain As Its Colon Disease Screening Test Goes For Sale At Walmart Online.
- The InFoods IBS DGT works by identifying above normal immunoreactivity to specific foods in patients. Food identified as positive is removed from the diet for the patient to feel better.
- Biomerica plans to meet and work with the FDA to design a final pivotal trial focused on the endpoint(s) that show the greatest improvement.
- The pivotal trial protocol is expected to be substantially similar to the completed endpoint trial, with more patients participating.
- Biomerica is also discussing opportunities to commercialize the InFoods IBS DGT before FDA clearance as a Laboratory Developed Test service offered through a CLIA laboratory and a CE Marked product in Europe or other countries.
- Price Action: BMRA shares are down 4.57% at $4.07 during the market session on the last check Tuesday.
© 2023 Benzinga.com. Benzinga does not provide investment advice. All rights reserved.