BMRA News & Events

Biomerica announced it has received its first commercial order for Hp Detect, its Helicobacter pylori diagnostic stool antigen test, from one of the largest clinical laboratory chains operating across Europe. The initial order is for the United Kingdom market, where Hp Detect received registration from the UK Medicines and Healthcare products Regulatory Agency, or MHRA in February. This commercial order represents a significant step in Biomerica's commercialization of Hp Detect throughout Europe. The customer's position as one of the leading clinical laboratory networks in Europe provides Biomerica with a high-profile account that the Company believes will support future distribution discussions across the broader EU market. H. pylori is one of the most prevalent bacterial infections worldwide, estimated to infect 45% of the population across Europe's five largest countries. It is the strongest known risk factor for gastric cancer and is designated by the WHO as a Class 1 carcinogen. The WHO also lists H. pylori among the 16 antibiotic-resistant bacteria posing the greatest threat to human health, increasing the urgency for accurate, timely diagnostics to guide appropriate treatment.

Biomerica announced that it has received official registration from the UK Medicines & Healthcare products Regulatory Agency, MHRA, for its hp+detect diagnostic test that detects Helicobacter pylori bacteria. This product will now be marketed to labs throughout the UK for the detection of H. pylori infection in patients. "Receiving MHRA registration for hp+detect is a meaningful commercial milestone that expands our international reach into the United Kingdom," said Zack Irani, CEO of Biomerica. "The UK represents an important addressable market given the high prevalence of H. pylori infection across Europe. This registration reflects our ongoing commitment to delivering innovative diagnostic solutions to patients and clinicians worldwide."

Biomerica announced responder analysis results from its ongoing real-world study of inFoods IBS. The data demonstrates that a majority of patients achieved clinically meaningful reductions in both abdominal pain and bloating-the two most debilitating symptoms of Irritable Bowel Syndrome. The analysis was conducted on 69 patients who completed the full 8-week study protocol with both baseline and endpoint assessments. The FDA-recognized responder definition of greater than or equal to30% improvement in weekly average symptom scores was applied-the same endpoint used in the Company's peer-reviewed randomized controlled trial published in Gastroenterology: Abdominal Pain: 59.4% of patients met the responder threshold. Bloating: 68.1% of patients met the responder threshold. Among the 69 patients, 62 patients tested positive for one or more food sensitivities on the IBS-specific IgG assay: Mean abdominal pain scores decreased 34.6%, from 3.24 at baseline to 2.12 at 8 weeks Mean bloating scores declined 41.7%, from 4.35 to 2.54 at 8 weeks. These results validate the inFoods IBS test in a real-world clinical setting using the same rigorous endpoints the FDA applies to clinical trials for IBS drug therapies, demonstrating clinical utility beyond controlled trial conditions. These real-world findings build on a peer-reviewed, randomized controlled clinical trial of inFoods IBS which is published in Gastroenterology. That study was conducted across five major academic centers, including Mayo Clinic, Cleveland Clinic, Beth Israel Deaconess Medical Center, the University of Michigan, and Houston Methodist Hospital. That pivotal study demonstrated significantly greater abdominal pain relief in the treatment arm versus the sham diet arm. The 59.4% real-world pain responder rate from the use of inFoods IBS closely mirrors the 59.6% result from the controlled trial-offering an unusual degree of consistency between controlled and real-world settings that strengthens confidence in the product's clinical utility.

Biomerica announced that Vietnam's Hanoi Department of Health has officially approved the EZ Detect colorectal disease at-home screening test for sales and distribution throughout Vietnam. Biomerica is working with a major healthcare products distributor in Vietnam who will manage the sales and distribution of the product through pharmacies, hospitals, physician's offices, and direct online sales channels. "This approval is a milestone in Biomerica's global expansion and represents a meaningful opportunity to save lives in a region with high unmet need and growing commitment to improving healthcare access.," said Zack Irani, CEO of Biomerica. "We are committed to working with our distribution partner to ensure this tool reaches as many Vietnamese citizens as possible. This approval also serves as a template for expansion across additional Southeast Asian markets. Access to simple, at-home screening tests is an important step towards saving lives around the world, and we remain dedicated to our mission of providing easier access to healthcare solutions that make a real difference."