Biomerica Inc【BMRA】株式ニュース

United Arab Emirates Ministry of Health and Prevention Approves Biomerica’s Fortel® PSA Screening Test to Detect an Early Sign of Prostate Cancer
- 10-Minute PSA Test for Early Detection of Prostate Specific Antigen (PSA), an Early Warning Sign of Prostate Cancer

- Prostate Cancer: The Second Most Common Cancer in Men Globally

IRVINE, Calif., Jan. 16, 2025 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA), a global provider of innovative diagnostic solutions, is proud to announce that its Fortel® Prostate Specific Antigen (PSA) Screening Test has received approval from the United Arab Emirates Ministry of Health and Prevention (MOHAP).

The Fortel® PSA Screening Test is a user-friendly diagnostic tool that provides accurate results in just 10 minutes using a simple finger-prick blood sample. By measuring elevated PSA levels, a recognized early marker of prostate disease, the test can enable early detection of prostate cancer and other prostate-related conditions. This rapid and accessible approach aims to enhance proactive health management, reduce the burden on healthcare systems, and improve patient outcomes.

Strategic Expansion in the Middle East

This milestone approval is part of Biomerica’s strategic initiative to expand its footprint in the Middle East, where prostate cancer is increasingly recognized as a critical public health concern. Building on its success in the region with the EZ Detect Colon Disease At-Home Screening Test, which received government insurance reimbursement in Dubai, Biomerica is working to replicating this achievement with the Fortel® PSA test. The Company has established partnerships with leading distributors and secured key regulatory approvals to make early cancer detection more accessible to patients in the region.

Proven Performance

The Fortel® PSA test has demonstrated outstanding performance in rigorous evaluations:

A study reported 100% sensitivity, 95% specificity, and 97.5% accuracy, aligning with laboratory reference methods.
Research conducted at the Faculty of Medicine, Ain Shams University in Egypt, further validated the test’s effectiveness, achieving 97.2% sensitivity, 96.2% specificity, and 96.7% accuracy.
These results highlight the Fortel® PSA test as a reliable and efficient tool for early detection.

The Growing Global and Regional Impact of Prostate Cancer

Prostate cancer is the second most common cancer among men worldwide, with 1.4 million new cases diagnosed and 375,000 deaths reported globally in 20201. Alarmingly, one new case is diagnosed every two minutes2. While extensive research and advancements in early detection have been made in Europe and North America, prostate cancer has become increasingly recognized as a significant public health challenge in the Middle East. The disease varies in prevalence and severity across different regions, age groups, ethnicities, and races and there remains a gap in comprehensive studies within the Middle East3.

Looking Ahead: Expanding Access to Life-Saving Diagnostics

Biomerica is reinforcing its commitment to expanding access to innovative diagnostic solutions in the Middle East. The company’s vision remains focused on providing affordable, accurate, and accessible tools to aid in the early detection and treatment of critical diseases like prostate cancer.

https://uroweb.org/guidelines/prostate-cancer/chapter/epidemiology-and-aetiology%E2%80%8B
https://zerocancer.org/about-prostate-cancer/facts-statistics
Mutlay Sayan et al. Prostate Cancer Awareness in the Middle East: A Cross-Sectional International Study. JCO Glob Oncol 10, e2400171(2024).
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, FDA and/or international regulatory authorization for the Company’s products to be marketed and sold, including the Fortel PSA product, 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, 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 impo