Biomerica reports developments in diagnostic-guided therapies and medical diagnostic products used in point-of-care, home, physician-office and clinical laboratory settings. The company focuses on gastrointestinal and inflammatory diseases, with recurring updates around inFoods® IBS, a finger-stick blood test used to identify individual food triggers for IBS dietary guidance, and Hp Detect™/hp+detect™, an H. pylori stool antigen diagnostic.
Biomerica news also covers commercialization and regulatory activity for products such as EZ Detect™, an at-home colorectal disease screening test, along with international distribution, laboratory partnerships, reimbursement and coding updates, clinical data presentations, fiscal results and the company’s CDMO services activity.
Biomerica (Nasdaq: BMRA) has launched the inFoods® IBS Trigger Food Navigator, an AI-powered digital tool designed to enhance their existing IBS diagnostic solution. The Navigator helps patients better manage their IBS symptoms by providing smart meal suggestions and ingredient substitutions based on their personalized trigger food profile.
The company's clinical studies showed significant results, with 59.6% of treatment group patients achieving FDA's endpoint for abdominal pain reduction compared to 42.2% in the control group. Even higher success rates were observed in IBS-C (67.1%) and IBS-M (66.0%) patients.
Developed with University of Michigan dietitians, the Navigator includes features like smart food identification, AI-driven meal suggestions, and an alternative food database. The tool is provided at no additional cost to existing inFoods® IBS test customers and is available through healthcare providers or online for new patients.
Biomerica (NASDAQ:BMRA) has received approval from the UAE Ministry of Health and Prevention for its Fortel® Kidney Test for home use. The 10-minute diagnostic test detects early kidney damage by identifying low albumin levels in urine, particularly targeting patients with diabetes and hypertension.
The approval addresses a significant market, as approximately 25% of UAE nationals have diabetes, while hypertension affects 31% of adults in the region. The test will be distributed through pharmacies, clinics, and hospitals throughout the UAE, expanding Biomerica's presence in the Middle East following the success of its EZ Detect™ Colon Disease Test.
Biomerica (NASDAQ: BMRA) reported its fiscal year 2025 results, showing a 19% improvement in operating loss to $5.1 million despite slight revenue decline. The company achieved $5.3 million in revenue, down from $5.4 million in the previous year, with gross profit at $498,000.
Key achievements include $1.3 million in operating expense reductions and improved cash management, with cash used in operations decreasing to $3.8 million from $5.3 million. Strategic milestones include receiving a PLA code for inFoods® IBS test, expanding in the MENA region, and launching direct-to-consumer availability of inFoods® IBS with a new patient self-collection system.
The company secured EU IVDR certification for food-intolerance diagnostic tests and obtained three new international patents for its inFoods® technology platform applications in various gastrointestinal conditions.
Biomerica (Nasdaq: BMRA) has received approval from the UAE Ministry of Health and Prevention for its Fortel® Ulcer Test for home use. This 10-minute diagnostic test detects antibodies to Helicobacter pylori (H. pylori), a bacterium affecting 41% of the UAE population and linked to approximately 80% of gastric cancer cases.
The test will be distributed through UAE-based partners and made available at pharmacies, clinics, and online platforms. H. pylori, classified as a Class 1 carcinogen by WHO, can lead to serious complications in up to 20% of infected individuals if untreated, including peptic ulcers and gastric cancer. This approval strengthens Biomerica's presence in the Middle East market, following their successful launch of the EZ Detect™ Colon Disease Test.
Biomerica (NASDAQ: BMRA) has achieved a significant milestone as its inFoods® IBS test received a CPT® Proprietary Laboratory Analysis (PLA) code from the American Medical Association CPT editorial panel. The code, effective October 1, 2025, enables insurance claims submission to Medicare and private insurers.
The inFoods® IBS test is a pioneering diagnostic tool that identifies patient-specific food triggers for IBS symptoms. Clinical trial results published in Gastroenterology demonstrated significant symptom reduction in patients following test-based dietary recommendations. The test addresses a substantial market, as IBS affects 10-15% of U.S. adults with $10 billion in direct annual medical costs.
Biomerica (NASDAQ: BMRA) has appointed Scott Madel as Chief Commercial Officer to accelerate the commercialization of inFoods® IBS. Madel brings over 20 years of experience in healthcare and diagnostics, most recently serving as President of Boston Heart Diagnostics. His track record includes leading successful organizational turnarounds and growing Genova Diagnostics to over $100 million in annual revenue.
In his new role, Madel will focus on strategic partnerships, payer strategy, achieving 3rd party reimbursement, and expanding provider engagement for inFoods® IBS. His appointment aims to drive revenue growth and market expansion for Biomerica's innovative gastroenterology solutions.
Biomerica (NASDAQ: BMRA) reported significant real-world data for its inFoods® IBS diagnostic-guided therapy, showing remarkable symptom reduction in IBS patients. Data from over 360 patients demonstrated a 48.5% reduction in gastrointestinal pain and a 49.8% reduction in bloating over an 8-week period.
The company also launched a HIPAA-compliant real-time patient feedback system that enables physicians to track symptoms and adjust treatment plans accordingly. These results complement a peer-reviewed study published in Gastroenterology, which showed that patients on an inFoods® IBS-guided diet experienced significantly more abdominal pain relief compared to placebo (59.6% vs. 42.1%, p-value=0.02).
The solution targets a substantial market, as IBS affects 10-15% of U.S. adults, offering a personalized, non-drug approach to identify and eliminate specific food triggers causing IBS symptoms.