Biomerica Receives MHRA Registration for hp+detect™, Allowing Commercial Sales in Great Britain
Registration marks the Company’s entry into the UK market, where H. pylori affects an estimated 45% of the population across Europe’s five largest countries
- UK Market Entry:MHRA registration authorizes hp+detect™ for commercial sale in Great Britain
- Active Commercialization:Biomerica is in active discussions with UK partners to access the diagnostic laboratory market and expects to provide further updates as agreements are finalized.
- Disease Burden:The WHO designates H. pylori as a Class 1 carcinogen and lists it among the 16 antibiotic-resistant bacteria posing the greatest global health threat — underscoring the clinical need for accurate diagnostics.
IRVINE, Calif., March 05, 2026 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced medical diagnostic and therapeutic products, today 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 (H. pylori) bacteria. This product will now be marketed to labs throughout the UK for the detection of H. pylori infection in patients.
The Biomerica hp+detect™ product detects H. pylori bacteria, which is estimated to infect 35% of the U.S. population and 45% of the population in Europe’s five largest countries. H. pylori infection is the strongest known risk factor for gastric cancer, which is the third most common cause of cancer-related death worldwide. The WHO has designated H. pylori as a Class 1 carcinogen and lists it among the 16 antibiotic-resistant bacteria that pose the greatest threat to human health. Physicians and medical centers will be able to use hp+detect™ to diagnose H. pylori infection and monitor efficacy of treatments used to eradicate the infection.
H. pylori is one of the most prevalent bacterial infections worldwide, affecting an estimated 44% of the global population. It is the leading cause of peptic ulcer disease and a primary driver of gastric cancer — the third most common cause of cancer-related death globally. In the United Kingdom, H. pylori infection remains a significant public health burden, and the availability of accurate, non-invasive diagnostic tools is critical to enabling timely clinical intervention and appropriate antibiotic therapy in an era of increasing antimicrobial resistance.
“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.”
About Biomerica (Nasdaq: BMRA)
Biomerica, Inc. (www.biomerica.com) is a global biomedical technology company that develops, patents, manufactures and markets advanced diagnostic and therapeutic products used at the point-of-care (in home and in physicians’ offices) and in hospital/clinical laboratories for detection and/or treatment of medical conditions and diseases. The Company’s products are designed to enhance the health and well-being of people, while reducing total healthcare costs. Biomerica primarily focuses on gastrointestinal and inflammatory diseases where the Company has multiple diagnostic and therapeutic products in development.
Forward-Looking Statements
The Private Securities Litigation Reform Act of 1995 provides a “safe harbor” for forward-looking statements. Certain information included in this press release contains statements that are forward-looking, such as statements relating to the Company’s estimated future financial results, demand for the Company’s products, the Company’s ability to fulfill orders, regulatory clearance of the Company’s tests and products, and the possible success of our products once introduced into the market. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results in the future, including, without limitation: results of studies testing the safety and efficacy of the Company’s hp+detect™ test and actual safety and efficacy in patients; acceptance, adoption and sales of the hp+detect™ product within the medical community in the UK; regulatory approvals necessary prior to commercialization in additional countries, including FDA clearance; availability of the Company’s test kits and other products; capacity, resource and constraints on our suppliers; competition from other similar products and from competitors that have significantly more financial and other resources available to them; the Company’s ability to comply with current and future regulations in the countries where our products are made and sold; and the Company’s ability to obtain patent protection and freedom to operate on any aspects of its diagnostic technologies. Accordingly, such future financial results may differ materially from those expressed in any forward-looking statements made by or on behalf of Biomerica. Additionally, potential risks and uncertainties include, among others, fluctuations in the Company’s operating results due to its business model and expansion plans, downturns in international and or national economies, the Company’s ability to raise additional capital, the competitive environment in which the Company will be competing, and the Company’s dependence on strategic relationships. The Company is under no obligation to update any forward-looking statements after the date of this release.
Investor Contact: Zack Irani | +1 949-645-2111 | investors@biomerica.com
Source: Biomerica, Inc.
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