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.
Biomerica, a global provider of advanced medical diagnostic and therapeutic products, 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.
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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.”
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