- 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.
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).
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 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
