Biomerica announced that the Hanoi Department of Health has granted nationwide approval for its EZ Detect colorectal disease at‑home screening test, allowing the company to sell and distribute the product across Vietnam’s pharmacies, hospitals, physician offices, and online platforms. The approval, announced on February 18, 2026, removes a key regulatory hurdle and positions Biomerica to tap into a market of more than 100 million people with a growing demand for early cancer detection.
EZ Detect is a two‑minute, at‑home test that detects blood in stool through a color change on a test pad. The product is FDA‑cleared and offers a convenient, no‑stool‑handling solution that delivers rapid results, making it well suited for widespread use in a country where colorectal cancer screening rates are low.
Vietnam’s colorectal cancer landscape underscores the importance of this approval. In 2022, the country reported 16,835 new colorectal cancer cases, ranking it fourth among all cancers, and the five‑year survival rate sits at only 45 %. Early detection through a simple at‑home test could significantly improve outcomes in a population where survival rates lag behind those in developed nations.
Biomerica plans to partner with a major Vietnamese distributor to manage nationwide sales and distribution. The approval enables the company to leverage its existing distribution network and to introduce EZ Detect through multiple channels, including pharmacies, hospitals, physician offices, and direct online sales, thereby expanding its market reach in Southeast Asia.
Financially, Biomerica’s Q2 fiscal 2026 results showed a net loss of $1.32 million, compared with a $0.95 million loss in the same quarter of the prior year, and net sales of $1.21 million versus $1.64 million year‑over‑year. Management attributed the decline in sales to the absence of large initial distributor stocking orders in the MENA region, highlighting the company’s ongoing efforts to scale its product portfolio and manage inventory levels.
CEO Zack Irani emphasized that the Vietnam approval is a milestone in Biomerica’s global expansion strategy and a meaningful opportunity to save lives in a region with high unmet need. The announcement signals the company’s commitment to expanding its footprint in emerging markets and demonstrates its ability to secure international clearances.
The approval not only opens a new revenue stream for Biomerica but also serves as a model for future market entries in the region. By addressing a critical public health need—early detection of colorectal cancer in a country with low survival rates—the company strengthens its competitive position and reinforces its regulatory expertise. The move aligns with Biomerica’s broader strategy of expanding its diagnostic portfolio and leveraging its FDA‑cleared products to capture growth in high‑potential markets.
Overall, the nationwide approval for EZ Detect in Vietnam represents a significant step forward for Biomerica, combining regulatory success with a clear path to market penetration in a high‑growth Southeast Asian country. The company’s financial performance remains a challenge, but the approval provides a tangible opportunity to improve its revenue base and to demonstrate the value of its at‑home screening technology in a new market.
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