United Arab Emirates Ministry of Health and Prevention Approves Biomerica’s Fortel® Ulcer Test for Home Use

Rhea-AI Summary

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.

Positive

• 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

Negative

• Faces competition in a market with existing H. pylori testing solutions
• Success dependent on consumer adoption of home testing concept

Insights

Medical Diagnostics Expert

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 41% of the UAE population

The clinical significance here is substantial. H. pylori is classified as a Class 1 carcinogen by the WHO and is linked to roughly 80% of gastric cancer cases globally. With gastric cancer ranking as the fifth most common cancer worldwide and fourth leading cause of cancer-related deaths, early detection could significantly impact patient outcomes.

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 20% of infected individuals may develop serious complications without treatment.

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 41% of the UAE population, with higher prevalence among certain age and ethnic groups. If left untreated, up to 20% of infected individuals may develop serious complications such as peptic ulcers, chronic digestive pain, or gastric malignancies. Up to 80% of gastric cancer cases are linked to H. pylori infection, making it one of the most concerning infectious cancer risk factors. In recognition of its global impact, the World Health Organization (WHO) has classified H. pylori as a Class 1 carcinogen and listed it among the top antibiotic-resistant bacterial threats to human health.

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: 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

What is the significance of Biomerica's (BMRA) Fortel® Ulcer Test approval in UAE?

The approval allows home use of the 10-minute diagnostic test that detects H. pylori antibodies, a bacterium affecting 41% of UAE population and linked to serious gastric conditions including cancer.

How prevalent is H. pylori infection in the UAE market for BMRA's test?

H. pylori affects approximately 41% of the UAE population, with up to 20% of infected individuals at risk of developing serious complications if left untreated.

What are the potential complications of H. pylori that BMRA's test can help detect?

If untreated, H. pylori can cause peptic ulcers, chronic digestive pain, and gastric malignancies, with up to 80% of gastric cancer cases linked to H. pylori infection.

How will Biomerica distribute the Fortel® Ulcer Test in the UAE?

Biomerica is partnering with UAE-based distributors to make the test available through pharmacies, clinics, and online platforms.

What is the WHO classification of H. pylori that BMRA's test detects?

The World Health Organization has classified H. pylori as a Class 1 carcinogen and listed it among the top antibiotic-resistant bacterial threats to human health.