Biomerica announced that its hp+detect™ diagnostic test for Helicobacter pylori has received official registration from the UK Medicines & Healthcare products Regulatory Agency (MHRA). The approval allows the company to market the test to laboratories across the United Kingdom, giving it a new revenue stream in a country where H. pylori infection is common.
The United Kingdom has a high prevalence of H. pylori, with estimates ranging from 15% to 40% of the population infected. The World Health Organization classifies H. pylori as a Class 1 carcinogen and lists it among the 16 antibiotic‑resistant bacteria that pose the greatest global health threat, underscoring the clinical need for accurate diagnostics.
Biomerica’s Q2 fiscal 2026 results showed net sales of $1.21 million, down from $1.64 million in the same quarter a year earlier, and a net loss. Management noted that gross margins are expected to expand as sales of hp+detect™ scale, reflecting the company’s focus on high‑margin diagnostic products and its growing contract development and manufacturing organization (CDMO) services.
CEO Zack Irani said, "Receiving MHRA registration for hp+detect™ is a meaningful commercial milestone that expands our international reach into the United Kingdom." He added, "The UK represents an important addressable market given the high prevalence of H. pylori infection across Europe."
The hp+detect™ test is a stool antigen ELISA that received U.S. FDA 510(k) clearance on December 18 2023 and a CE mark in May 2022, allowing sale in the EU. Biomerica’s broader portfolio focuses on gastrointestinal and inflammatory diseases, and the company maintains a strong balance sheet with low debt while expanding its CDMO services.
The MHRA registration marks a significant step in Biomerica’s strategy to broaden its global footprint and capitalize on the high demand for H. pylori diagnostics, positioning the company to capture a sizable share of the UK laboratory market.
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