United Arab Emirates Ministry of Health and Prevention Approves Biomerica’s Fortel® Ulcer Test for Detection of H. pylori Infection
Biomerica (Nasdaq: BMRA) has received approval from the UAE Ministry of Health and Prevention for its Fortel® Ulcer Test, a rapid diagnostic tool for detecting H. pylori infection. The test delivers results in 10 minutes and identifies the bacterium responsible for peptic ulcers, dyspepsia, and gastric cancer.
H. pylori affects approximately 35% of the U.S. population, 45% in major European countries, and over 50% in the UAE. The WHO has classified it as a Class 1 carcinogen, with 15-20% of infected individuals developing complications. Notably, about 80% of gastric cancer cases, the third most common cause of cancer-related death globally, are linked to H. pylori infection.
This approval strengthens Biomerica's presence in the Middle East, following previous launches of other diagnostic products. The company is working with UAE-based distributors to make the test available throughout the country.
Biomerica (Nasdaq: BMRA) ha ottenuto l'approvazione dal Ministero della Salute e della Prevenzione degli Emirati Arabi Uniti per il suo Fortel® Ulcer Test, uno strumento diagnostico rapido per rilevare l'infezione da H. pylori. Il test fornisce risultati in 10 minuti e identifica il batterio responsabile di ulcere peptiche, dispepsia e cancro gastrico.
H. pylori colpisce circa il 35% della popolazione negli Stati Uniti, il 45% nei principali paesi europei e oltre il 50% negli Emirati Arabi Uniti. L'OMS lo ha classificato come cancerogeno di Classe 1, con il 15-20% degli individui infetti che sviluppano complicazioni. In particolare, circa l'80% dei casi di cancro gastrico, la terza causa più comune di morte per cancro a livello mondiale, è associato all'infezione da H. pylori.
Questa approvazione rafforza la presenza di Biomerica in Medio Oriente, a seguito del lancio di altri prodotti diagnostici. L'azienda sta collaborando con distributori locali per rendere il test disponibile in tutto il paese.
Biomerica (Nasdaq: BMRA) ha recibido la aprobación del Ministerio de Salud y Prevención de los Emiratos Árabes Unidos para su Fortel® Ulcer Test, una herramienta diagnóstica rápida para detectar la infección por H. pylori. La prueba ofrece resultados en 10 minutos e identifica la bacteria responsable de úlceras pépticas, dispepsia y cáncer gástrico.
H. pylori afecta aproximadamente al 35% de la población de EE. UU., al 45% en los principales países europeos y a más del 50% en los Emiratos Árabes Unidos. La OMS la ha clasificado como carcinógeno de Clase 1, con un 15-20% de los infectados que desarrollan complicaciones. Cabe destacar que alrededor del 80% de los casos de cáncer gástrico, la tercera causa más común de muerte por cáncer a nivel mundial, están relacionados con la infección por H. pylori.
Esta aprobación fortalece la presencia de Biomerica en Oriente Medio, tras el lanzamiento previo de otros productos diagnósticos. La empresa está trabajando con distribuidores locales para que la prueba esté disponible en todo el país.
Biomerica (나스닥: BMRA)는 UAE 보건예방부로부터 Fortel® Ulcer Test에 대한 승인을 받았습니다. 이 신속 진단 도구는 H. pylori 감염을 10분 내에 검출하며, 소화성 궤양, 소화불량, 위암을 일으키는 박테리아를 식별합니다.
H. pylori는 미국 인구의 약 35%, 주요 유럽 국가의 45%, UAE 인구의 50% 이상에 영향을 미칩니다. WHO는 이를 1급 발암물질로 분류했으며, 감염자의 15-20%는 합병증을 겪습니다. 특히 전 세계적으로 암 사망 원인 중 세 번째로 흔한 위암 환자의 약 80%가 H. pylori 감염과 관련되어 있습니다.
이번 승인은 Biomerica가 중동 지역에서의 입지를 강화하는 계기가 되었으며, 이전에 출시한 다른 진단 제품들에 이어 UAE 내 유통업체와 협력하여 전국적으로 테스트를 제공할 계획입니다.
Biomerica (Nasdaq : BMRA) a obtenu l'approbation du Ministère de la Santé et de la Prévention des Émirats arabes unis pour son Fortel® Ulcer Test, un outil de diagnostic rapide permettant de détecter l'infection à H. pylori. Le test fournit des résultats en 10 minutes et identifie la bactérie responsable des ulcères gastriques, de la dyspepsie et du cancer de l'estomac.
H. pylori touche environ 35 % de la population américaine, 45 % dans les principaux pays européens et plus de 50 % aux Émirats arabes unis. L'OMS l'a classée comme cancérogène de classe 1, avec 15 à 20 % des personnes infectées développant des complications. Notamment, environ 80 % des cas de cancer gastrique, la troisième cause la plus fréquente de décès par cancer dans le monde, sont liés à l'infection par H. pylori.
Cette approbation renforce la présence de Biomerica au Moyen-Orient, après le lancement précédent d'autres produits diagnostiques. L'entreprise collabore avec des distributeurs basés aux Émirats pour rendre le test disponible dans tout le pays.
Biomerica (Nasdaq: BMRA) hat die Zulassung des Gesundheitsministeriums der Vereinigten Arabischen Emirate für seinen Fortel® Ulcer Test erhalten, ein schnelles Diagnosewerkzeug zur Erkennung einer H.-pylori-Infektion. Der Test liefert Ergebnisse in 10 Minuten und identifiziert das Bakterium, das für Magengeschwüre, Dyspepsie und Magenkrebs verantwortlich ist.
H. pylori betrifft etwa 35 % der US-Bevölkerung, 45 % in den wichtigsten europäischen Ländern und über 50 % in den VAE. Die WHO hat es als Karzinogen der Klasse 1 eingestuft, wobei 15-20 % der Infizierten Komplikationen entwickeln. Bemerkenswert ist, dass etwa 80 % der Magenkrebsfälle, der dritthäufigsten krebsbedingten Todesursache weltweit, mit einer H.-pylori-Infektion in Verbindung stehen.
Diese Zulassung stärkt die Präsenz von Biomerica im Nahen Osten, nachdem bereits andere diagnostische Produkte eingeführt wurden. Das Unternehmen arbeitet mit in den VAE ansässigen Vertriebspartnern zusammen, um den Test landesweit verfügbar zu machen.
- Secured regulatory approval in UAE, expanding market presence in Middle East
- Addresses a significant market with over 50% H. pylori infection rate in UAE
- Quick 10-minute test results enable rapid diagnosis and treatment
- None.
Insights
Biomerica's rapid H. pylori test approval in UAE addresses critical need in region with 50%+ infection rates, expanding market presence.
The UAE Ministry of Health's approval of Biomerica's Fortel® Ulcer Test represents a significant clinical advancement in a region where H. pylori infection rates exceed 50% of the population. This 10-minute point-of-care diagnostic addresses a substantial public health concern, detecting a bacterium the WHO classifies as a Class 1 carcinogen.
The clinical significance cannot be overstated - H. pylori infection is directly linked to approximately 80% of gastric cancer cases, which ranks as the third most common cause of cancer-related deaths globally. The test's rapid results enable immediate clinical decision-making, a crucial advantage over laboratory-dependent diagnostics that delay treatment initiation.
From a pathophysiological perspective, early detection is vital as 15-20% of infected individuals develop serious complications including peptic ulcers and gastric cancer. The antibody detection methodology provides clinicians with actionable diagnostic information in just 10 minutes, potentially reducing disease progression through timely intervention.
The approval builds strategically upon Biomerica's existing Middle East footprint, where they've already established distribution networks through previous product launches including the EZ Detect™ Colon Disease Test, suggesting infrastructure for rapid market penetration is already in place.
Biomerica gains access to UAE's substantial H. pylori market through regulatory approval, expanding their Middle East diagnostic portfolio.
This regulatory milestone gives Biomerica access to a significant addressable market where local studies estimate H. pylori infection rates exceeding 50% of the UAE population. The approval represents meaningful market expansion in the Gulf region, where gastrointestinal diseases constitute a growing public health concern.
The diagnostic addresses a substantial clinical need – H. pylori affects approximately 35% of the U.S. population and 45% of the population in the five largest European countries, with UAE rates even higher. This creates a compelling market opportunity, particularly considering 15-20% of infected individuals develop complications requiring medical intervention.
The 10-minute result timeframe positions the Fortel® Ulcer Test competitively in the point-of-care diagnostic landscape, where speed and convenience drive clinical adoption. The company's statement about collaboration with UAE-based distributors suggests an established commercialization strategy leveraging existing relationships.
This approval strengthens Biomerica's regional diversification strategy, following earlier successful launches in the Middle East. The product complements their existing diagnostic portfolio, including the previously launched EZ Detect™ Colon Disease Test, creating potential for bundled offerings to healthcare providers in the region.
- 10-minute test enables detection of Helicobacter pylori, a leading cause of peptic ulcers, dyspepsia, and gastric cancer
- Approximately
80% of gastric cancer cases are linked to H. pylori infection; WHO classifies H. pylori as a Class 1 carcinogen - This test empowers healthcare providers with fast, accessible testing across the UAE
IRVINE, Calif., April 23, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of advanced diagnostic solutions, announced today that its Fortel® Ulcer Test has been approved for sale by the United Arab Emirates (UAE) Ministry of Health and Prevention. This regulatory approval enables Biomerica to introduce its rapid point-of-care test for Helicobacter pylori (H. pylori) infection across the UAE—a region where gastrointestinal diseases are a growing public health concern.
The Fortel® Ulcer Test is a simple, quick and user-friendly diagnostic tool that detects antibodies to H. pylori, a bacterium known to cause peptic ulcer disease, dyspepsia, and gastric cancer. The test delivers accurate results in just 10 minutes.
A Major Global and Regional Health Threat
H. pylori infects approximately
Gastric Cancer: A Deadly Consequence of H. pylori Infection
Gastric cancer is the 3rd most common cause of cancer-related death globally, and approximately
“The Fortel® Ulcer Test empowers healthcare providers to rapidly detect H. pylori infection and take timely action to prevent serious gastrointestinal diseases, including cancer,” said Zack Irani, CEO of Biomerica. “We’re proud to support the UAE’s health system with this important tool for earlier detection and better outcomes.”
Strengthening Biomerica’s Regional Impact
This approval further expands Biomerica’s growing footprint in the Middle East, following successful regional launches of the EZ Detect™ Colon Disease Test and other diagnostic products. The Company is collaborating with UAE-based distributors and healthcare providers to make the Fortel® Ulcer Test available throughout the country.
Focused on Early Detection and Better Health Outcomes
Biomerica is committed to delivering affordable, innovative diagnostic tools that improve patient outcomes through early disease detection. The Fortel® Ulcer Test represents an easy to implement solution in the fight against H. pylori-related illnesses and reflects the company’s mission to improve global health with fast, accessible diagnostics.
About Biomerica (NASDAQ: BMRA)
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
www.biomerica.com
Source: Biomerica
FAQ
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