United Arab Emirates Ministry of Health and Prevention Approves Biomerica’s Fortel® Ulcer Test for Home Use
Biomerica (Nasdaq: BMRA) has received approval from the UAE Ministry of Health and Prevention for its Fortel® Ulcer Test for home use. This 10-minute diagnostic test detects antibodies to Helicobacter pylori (H. pylori), a bacterium affecting 41% of the UAE population and linked to approximately 80% of gastric cancer cases.
The test will be distributed through UAE-based partners and made available at pharmacies, clinics, and online platforms. H. pylori, classified as a Class 1 carcinogen by WHO, can lead to serious complications in up to 20% of infected individuals if untreated, including peptic ulcers and gastric cancer. This approval strengthens Biomerica's presence in the Middle East market, following their successful launch of the EZ Detect� Colon Disease Test.
Biomerica (Nasdaq: BMRA) ha ottenuto l'approvazione dal Ministero della Salute e della Prevenzione degli Emirati Arabi Uniti per il suo Fortel® Ulcer Test per uso domiciliare. Questo test diagnostico di 10 minuti rileva gli anticorpi contro Helicobacter pylori (H. pylori), un batterio che interessa il 41% della popolazione degli EAU e collegato a circa il 80% dei casi di cancro gastrico.
Il test sarà distribuito tramite partner con sede negli EAU e sarà disponibile in farmacie, ambulatori e piattaforme online. L'H. pylori, classificato dall'OMS come carcinogeno di Classe 1, può causare complicanze gravi nel 20% degli individui infetti se non trattato, incluse ulcere peptiche e cancro gastrico. Questa approvazione rafforza la presenza di Biomerica nel mercato del Medio Oriente, dopo il lancio di successo del test EZ Detect� Colon Disease Test.
Biomerica (Nasdaq: BMRA) ha recibido la aprobación del Ministerio de Salud y Prevención de los EAU para su Fortel® Ulcer Test de uso doméstico. Esta prueba diagnóstica de 10 minutos detecta anticuerpos contra Helicobacter pylori (H. pylori), una bacteria que afecta al 41% de la población de los EAU y se relaciona con aproximadamente el 80% de los casos de cáncer gástrico.
La prueba se distribuirá a través de socios con base en los EAU y estará disponible en farmacias, clínicas y plataformas online. H. pylori, clasificada por la OMS como carcinógeno de Clase 1, puede provocar complicaciones graves en hasta el 20% de las personas infectadas si no se trata, incluidas úlceras pépticas y cáncer gástrico. Esta aprobación refuerza la presencia de Biomerica en el mercado de Oriente Medio, tras el exitoso lanzamiento del test EZ Detect� Colon Disease Test.
Biomerica (Nasdaq: BMRA)� 자사� 가정용 Fortel® Ulcer Test� 대� 아랍에미리트(UAE) 보건예방부� 승인� 받았습니�. � 10분간� 진단검사는 Helicobacter pylori(H. pylori)� 대� 항체� 검출하�, � 세균은 UAE 인구� 41%� 영향� 미치� 위암 사례� � 80%와 관련이 있습니다.
� 테스트는 UAE� 기반� � 파트너를 통해 유통되며 약국, 클리� � 온라� 플랫폼에� 제공� 예정입니�. H. pylori� WHO가 1� 발암물질� 분류했으�, 치료하지 않으� 감염자의 최대 20%에서 위궤� � 위암� 포함� 심각� 합병증을 초래� � 있습니다. 이번 승인은 EZ Detect� Colon Disease Test� 성공적인 출시� 이어 Biomerica� 중동 시장 � 입지� 강화합니�.
Biomerica (Nasdaq: BMRA) a obtenu l'autorisation du Ministère de la Santé et de la Prévention des EAU pour son Fortel® Ulcer Test à usage domestique. Ce test diagnostique de 10 minutes détecte les anticorps dirigés contre Helicobacter pylori (H. pylori), une bactérie qui touche 41% de la population des EAU et est liée à environ 80% des cas de cancer gastrique.
Le test sera distribué via des partenaires basés aux EAU et disponible en pharmacies, cliniques et sur les plateformes en ligne. H. pylori, classée par l'OMS comme cancérogène de classe 1, peut entraîner des complications graves chez jusqu'à 20% des personnes infectées si elle n'est pas traitée, notamment des ulcères peptiques et un cancer gastrique. Cette autorisation renforce la présence de Biomerica sur le marché du Moyen-Orient, après le lancement réussi du EZ Detect� Colon Disease Test.
Biomerica (Nasdaq: BMRA) hat die Zulassung des Fortel® Ulcer Test zur Anwendung zu Hause durch das Ministerium für Gesundheit und Prävention der VAE erhalten. Dieser 10-minütige Schnelltest erkennt Antikörper gegen Helicobacter pylori (H. pylori), ein Bakterium, das 41% der Bevölkerung der VAE betrifft und mit etwa 80% der Magenkrebsfälle in Verbindung gebracht wird.
Der Test wird über in den VAE ansässige Partner vertrieben und in Apotheken, Kliniken sowie über Online-Plattformen erhältlich sein. H. pylori, von der WHO als Karzinogen der Gruppe 1 eingestuft, kann unbehandelt bei bis zu 20% der Infizierten zu schweren Komplikationen führen, darunter peptische Geschwüre und Magenkrebs. Diese Zulassung stärkt Biomericas Präsenz im Markt des Nahen Ostens nach dem erfolgreichen Start des EZ Detect� Colon Disease Test.
- Regulatory approval in UAE expands market access for Fortel® Ulcer Test
- Large target market with 41% of UAE population affected by H. pylori
- Strategic partnerships with UAE distributors for widespread distribution
- Strengthens company's Middle East presence following previous successful product launches
- Faces competition in a market with existing H. pylori testing solutions
- Success dependent on consumer adoption of home testing concept
Insights
Biomerica's UAE approval for home H. pylori testing opens significant market opportunity in region with 41% infection prevalence.
The UAE Ministry of Health and Prevention's approval of Biomerica's Fortel® Ulcer Test represents a strategic market expansion for the company's diagnostic portfolio. This rapid test targets H. pylori, which affects approximately
The clinical significance here is substantial. H. pylori is classified as a Class 1 carcinogen by the WHO and is linked to roughly
What makes this approval particularly valuable is the home-use designation, which removes healthcare setting constraints and dramatically expands accessibility. The 10-minute test format addresses the critical need for convenient screening in a region where up to
This approval complements Biomerica's existing Middle East presence, following their EZ Detect� Colon Disease Test. The distribution partnerships mentioned will be crucial for market penetration across pharmacies, clinics, and online platforms. For a diagnostic company, securing regulatory approvals that expand addressable markets is a fundamental growth driver, especially when targeting conditions with high prevalence rates.
- 10-minute home test enables detection of Helicobacter pylori, a leading cause of peptic ulcers, dyspepsia, and gastric cancer
- H. pylori linked to approximately
80% of gastric cancer cases; classified as a Class 1 carcinogen by the World Health Organization - Gastric cancer ranks as the fifth most common cancer globally and the fourth leading cause of cancer-related deaths
IRVINE, Calif., Aug. 14, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced diagnostic solutions, today announced that the United Arab Emirates (UAE) Ministry of Health and Prevention has approved Biomerica’s Fortel® Ulcer Test for home use. This marks a milestone in expanding access to accurate, easy-to-use diagnostic tools for one of the leading causes of gastric disease in the region.
The Fortel® Ulcer Test is a 10-minute rapid diagnostic test that detects antibodies to Helicobacter pylori (H. pylori), a bacterium responsible for peptic ulcers, dyspepsia, and a significant portion of gastric cancer cases. With this new regulatory approval, individuals across the UAE can now self-administer the test in the comfort and privacy of their own homes.
A Widespread and Dangerous Infection
H. pylori affects approximately
Expanded Access and Regional Impact
With home-use approval now in place, Biomerica is partnering with UAE-based distributors and healthcare providers to make the Fortel® Ulcer Test available at pharmacies, clinics, and online platforms. This approval strengthens Biomerica’s growing presence in the Middle East, building on the successful regional launch of the EZ Detect� Colon Disease Test and other diagnostics designed for early detection and better patient outcomes.
“With this home-use approval, we’re giving people direct access to a reliable tool for early detection of a dangerous infection that could result in serious complications,� said Zack Irani, CEO of Biomerica. “This can help drive earlier and more effective medical treatment and potentially save lives.�
Committed to Early Detection and Better Health Outcomes
Biomerica remains focused on delivering affordable, innovative diagnostic tools that improve patient outcomes through early disease detection. The Fortel® Ulcer Test exemplifies an easy to implement solution in the fight against H. pylori-related illnesses and reflects the Company’s mission to improve global health with accessible and effective diagnostics.
About Biomerica (NASDAQ: )
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.
The Private Securities Litigation Reform Act of 1995 provides a "safe harbor" for forward-looking statements. Certain information included in this press release (as well as information included in oral statements or other written statements made or to be made by Biomerica) contains statements that are forward-looking, such as statements relating to the Company’s current and future sales, revenues, overhead, expenses, cost of goods, operations and earnings, efficacy of the Company’s products and tests including the Fortel® Ulcer Test, FDA and/or international regulatory authorization for the Company’s products to be marketed and sold, including the Fortel® Ulcer Test, and the Company’s other current and future products, the possible expansion in to other markets, uniqueness of the Company’s products, accuracy of the Company’s tests and products, pricing of the Company’s test kits, domestic and/or international market adoption and acceptance and demand for the Company’s products including the Fortel® Ulcer Test, future use of the Company's products by physicians to treat their patients, potential revenues from the sale of current or future products. Such forward-looking information involves important risks and uncertainties that could significantly affect anticipated results, in the future, including, without limitation: earnings and other financial results; results of studies testing the efficacy of the Company’s inFoods tests and other products; regulatory approvals necessary prior to commercialization of the Company’s products; availability of the Company’s test kits and other products; capacity, shipping logistics, resource and other constraints on our suppliers; dependence on our third party manufacturers; dependence on international shipping carriers; governmental import/export regulations; demand for our various tests and other products; competition from other similar products and from competitors that have significantly more financial and other resources available to them; governmental virus control regulations that make it difficult or impossible for the company to maintain current operations; regulatory compliance and oversite, and the Company’s ability to obtain patent protection on any aspects of its diagnostic or therapeutic technologies. Accordingly, such 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.
Corporate Contact:
Zack Irani | CEO
p. 949.645.2111
Source: Biomerica
