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) reported real-world responder results for inFoods® IBS: 59.4% of 69 patients had ≥30% abdominal pain reduction and 68.1% had ≥30% bloating reduction using the FDA-recognized responder endpoint.
Mean pain scores fell 34.6% and bloating 41.7% at 8 weeks. Commercial milestones include a $300 national Medicare rate (effective Jan 1, 2026), a dedicated CPT PLA code (effective Oct 1, 2025), and a Henry Schein marketing services agreement.
Biomerica (Nasdaq: BMRA) announced that Vietnam’s Hanoi Department of Health approved EZ Detect™ for nationwide sales and distribution on Feb 18, 2026. The FDA-cleared, two-minute at-home colorectal screening test will be sold via a major distributor across pharmacies, hospitals, clinics, and online channels.
The approval targets Vietnam’s high unmet need: 16,835 new colorectal cancer cases in 2022 and a reported 45% five-year survival rate, versus 91% when detected early in the US.
Biomerica (Nasdaq: BMRA) reported Q2 fiscal 2026 results for the period ended November 30, 2025. Q2 revenue was $1.21M versus $1.64M year-ago and six-month revenue was $2.59M versus $3.44M prior year. Management highlighted a strategic pivot to higher-margin diagnostic-guided therapy products and cost discipline. Working capital improved 14.7% (about $457k) and cash increased to $2.5M. CMS later established a $300 Medicare payment rate for inFoods IBS effective January 1, 2026. Operating expenses declined year-to-date and R&D spending was reduced by 27% as the company reallocates resources to commercialization.
Biomerica (Nasdaq: BMRA) announced that CMS set a national Medicare payment rate of $300 for the inFoods® IBS test under the CLFS, effective for services paid with dates of service on or after January 1, 2026. The test secured a dedicated CPT® PLA code effective October 1, 2025. Medicare represents roughly 21% of US healthcare spending and Medicare-age adults are a meaningful share of IBS patients, supporting potential access expansion.
Clinical data from a randomized, multicenter trial showed 59.6% response for trigger-food elimination versus 42.2% control; subgroup results included 67.1% (IBS-C) and 66% (IBS-M) meeting FDA pain-reduction targets.
Biomerica (Nasdaq: BMRA) announced on Dec 11, 2025 that the Egyptian Drug Authority authorized its complete portfolio of rapid screening tests for marketing and distribution in Egypt.
The authorization covers at‑home and point‑of‑care tests for colorectal disease, breast self exam, prostate (PSA), kidney (microalbumin) and H. pylori, offering results in minutes without lab processing to support mass screening and individual use across Egypt and the MENA region.
Biomerica (NASDAQ: BMRA) announced that its inFoods® IBS diagnostic-guided dietary therapy is featured in the Fall 2025 issue of Biotherapeutics Quarterly, highlighting results from a randomized, multicenter, double-blind, placebo-controlled trial.
The study enrolled 223 IBS patients across 8 U.S. academic centers and found 59.6% of treated patients met the FDA abdominal pain reduction target versus 42.1% for control. Subgroup results: IBS-C 67.1% vs 35.8%; IBS-M 66.0% vs 29.5%. The assay tests IgG responses to 18 IBS-specific foods and typically identifies elimination of 2–4 foods per patient, positioned as a more targeted alternative to broad diets like low-FODMAP.
Biomerica (Nasdaq: BMRA) announced an expansion of its Contract Development and Manufacturing Organization (CDMO) services on Nov 6, 2025 to meet rising demand from diagnostic and biotechnology companies.
The company highlighted end-to-end capabilities across LFA, point-of-care, ELISA, multiplex ELISA, antibody/reagent services, recombinant antibody development, manufacturing/assembly, and global supply chain & technology transfer. Biomerica cited ISO 13485, CE-mark expertise, and an FDA-registered cGMP facility and said CDMO work is a growing contributor to revenue.
Biomerica (NASDAQ: BMRA) announced on October 16, 2025 a marketing services agreement with Henry Schein (NASDAQ: HSIC) to market the inFoods® Irritable Bowel Syndrome (IBS) test across the U.S., excluding New York State. Henry Schein will leverage its nationwide network of >400 medical field sales and telesales representatives to promote the non‑drug, precision diagnostic therapy to primary care and gastroenterology practices.
A multicenter, double‑blinded study published in Gastroenterology (June 2025) showed statistically significant outcomes: 59.6% treatment vs 42.2% control for abdominal pain reduction overall; 67.1% vs 35.8% in IBS‑C; 66% vs 29.5% in IBS‑M. IBS affects an estimated 10–15% of U.S. adults.
Biomerica (Nasdaq: BMRA) reported first quarter fiscal 2026 results for the period ended August 31, 2025. Net sales were $1.4M versus $1.8M a year earlier, while gross margin rose to 31% from 16% driven by a higher‑margin product mix and contract manufacturing contribution. Operating expenses fell to $1.5M from $1.7M, producing an improved operating loss of $1.1M versus $1.4M. A non‑recurring tax credit produced a small net profit of about $2,000 versus a $1.3M loss prior year. Key commercial and regulatory updates include a PLA code for inFoods® IBS and UAE approvals for Fortel® Ulcer and Fortel® Kidney home tests, plus launch of an AI inFoods® IBS Trigger Food Navigator.
Biomerica (NASDAQ: BMRA) announced that Gary Huff was appointed to its Board of Directors as an independent director effective October 8, 2025. Mr. Huff brings decades of leadership in laboratory testing, clinical diagnostics, payor strategy, commercial launches, and sales growth, including prior service as Chief Executive Officer of LabCorp Diagnostics.
The company said Huff operates an advisory firm, sits on the boards of Lighthouse Labs and Tribal Diagnostics, and has advised health systems and firms such as McKinsey and Cerberus. Biomerica highlighted his experience as relevant to advancing its diagnostic portfolio, including the inFoods® IBS product.