Biomerica, Inc. (NASDAQ: BMRA) received full authorization from the Egyptian Drug Authority on December 11 2025 for its complete portfolio of rapid, at‑home screening tests, covering colorectal disease, breast self‑exam, prostate disease, kidney disease and Helicobacter pylori infection. The approval allows the company to market and distribute these tests throughout Egypt, opening a new geographic market for its point‑of‑care diagnostics.
The authorization is a significant milestone in Biomerica’s Middle East and North Africa expansion strategy. Egypt has a high prevalence of the target diseases—colorectal cancer is the seventh most common cancer, breast cancer is the most common among women, chronic kidney disease affects roughly 13 % of adults, and H. pylori infection rates range from 50 % to 70 %. The approval therefore positions Biomerica to participate in national screening initiatives and private retail channels, potentially generating new revenue streams in a country with substantial disease burden.
While the regulatory win opens a promising market, Biomerica remains unprofitable, reporting a negative EBITDA of $4.8 million over the last twelve months. The company’s cash position is strong, but the new market entry will require investment in distribution and local partnerships. The approval nonetheless validates the product portfolio and could serve as a launchpad for future introductions in neighboring MENA markets.
CEO Zack Irani said, “Authorization of our full screening portfolio by the Egyptian Drug Authority represents a milestone in expanding access to early detection in a region with growing chronic disease and cancer burdens. This authorization provides scalable tools for both individual testing and screening initiatives.” The statement underscores the company’s focus on expanding access to rapid diagnostics in high‑need regions.
Investors reacted positively to the announcement, with market sentiment reflecting confidence in the regulatory approval’s potential to unlock new revenue opportunities. The approval is viewed as a key driver of the company’s growth prospects in the MENA region.
Biomerica has previously secured approvals in the UAE and Saudi Arabia for select products, and the Egyptian authorization extends its presence across the entire rapid screening line. The portfolio includes the EZ Detect™ Colon Disease Test, Aware® Breast Self‑Exam, Fortel Prostate PSA Screening Test, Fortel Kidney Disease Microalbumin Test, and Fortel Ulcer H. pylori Screening Test, all designed for rapid, at‑home or point‑of‑care use.
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