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- 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.
- Biomerica announced the expansion of its Contract Development and Manufacturing Organization (CDMO) services to meet accelerating market demand from biotechnology and diagnostic companies. - The company leverages over 40 years of expertise in assay development, manufacturing, and regulatory compliance to provide end-to-end support from concept through commercial manufacturing. - Services include comprehensive capabilities spanning lateral flow assays, ELISA tests, antibody development, and manufacturing assembly, backed by ISO 13485 certification and FDA-registered cGMP facilities. - The CDMO services represent a growing revenue contributor and strategic growth opportunity as more organizations seek outsourced diagnostic development and production solutions.
- Biomerica has appointed Scott Madel as Chief Commercial Officer to accelerate commercialization of its inFoods IBS diagnostic test, bringing over 20 years of experience in laboratory testing and clinical diagnostics. - The inFoods IBS test demonstrated statistically significant efficacy in a multicenter clinical study published in Gastroenterology, with 59.6% of patients achieving FDA endpoints for abdominal pain reduction compared to 42.2% in the control group. - Madel will focus on strategic partnerships, payer strategy development, and scaling domestic and global provider engagement for the diagnostic-guided therapy that identifies patient-specific food triggers for IBS symptoms. - The test represents the only targeted therapy to demonstrate efficacy specifically in IBS-M patients, a historically underserved subgroup, according to the clinical study conducted at leading institutions including Cleveland Clinic and Mayo Clinic.
- Biomerica achieved CE-marking under the European Union's In Vitro Diagnostic Medical Devices Regulation (IVDR) for its food intolerance products designed for Crohn's Disease and Ulcerative Colitis patients. - The certification enables market access across Europe and positions the company to expand its presence in the European in vitro diagnostics market while meeting stringent safety and performance standards. - The proprietary diagnostic products use innovative technology to identify specific dietary triggers that may cause inflammation in IBD patients, offering a personalized approach to symptom management. - The global markets for these conditions are substantial, with Ulcerative Colitis expected to grow from $7.72 billion in 2024 to $12.03 billion by 2032, and Crohn's Disease therapeutics valued at $13.2 billion in 2023.
• Clinical trial results reveal inFoods IBS test achieved 59.6% success rate in reducing abdominal pain through targeted food elimination, compared to 42.2% in control group. • The test demonstrated exceptional efficacy in IBS-C and IBS-M subtypes, with 67.1% and 66% of patients respectively meeting FDA pain reduction targets. • Novel IBS-specific IgG antibody test enables precision nutrition approach by identifying individual trigger foods, requiring elimination of only 2-4 foods on average.
- Biomerica's Fortel PSA test has received approval from the UAE Ministry of Health and Prevention (MOHAP) for early prostate cancer detection. - The Fortel test utilizes a finger-prick blood sample to measure elevated PSA levels, providing results within ten minutes. - Clinical evaluations demonstrated high sensitivity (up to 100%), specificity (up to 96.2%), and accuracy (up to 97.5%) in detecting prostate cancer. - Biomerica aims to improve patient outcomes and reduce healthcare system strain through accessible and accurate early disease detection.
