- 10-Minute At-Home PSA Test for Early Detection of Prostate Cancer
- First order already shipped to Saudi Arabia
- Prostate Cancer is the Second Most Common Cancer in Men Globally
IRVINE, Calif., Sept. 04, 2024 (GLOBE NEWSWIRE) -- Biomerica, Inc. (Nasdaq: BMRA) is pleased to announce that the Saudi Food and Drug Authority (SFDA) has approved the Company's Fortel Prostate (PSA) Screening Test to be sold and used in the country. This at-home test is designed to empower men with the ability to detect early warning signs of prostate cancer from the comfort of their own homes.
The Fortel Prostate (PSA) At-Home Screening Test is a user-friendly, rapid diagnostic tool that measures elevated PSA, an early indicator of prostate disease, including cancer. Utilizing a simple finger-prick blood sample, the test delivers highly accurate results within just 10 minutes, making it an accessible and essential tool in the fight against prostate cancer.
Strategic Expansion in the Middle East
This approval marks a milestone in Biomerica's strategic expansion into the Middle East, a region where prostate cancer is increasingly recognized as a public health concern. Biomerica is dedicated to making early detection more accessible and has established partnerships with leading distributors, secured key regulatory approvals, and achieved insurance reimbursement from the Dubai government for its EZ Detect Colon Disease at-home Screening Test. The company is now working to replicate this success with the Fortel PSA test across the region.
Proven Performance
The Fortel PSA test has demonstrated exceptional performance. A study reported 100% sensitivity, 95% specificity, and 97.5% accuracy compared to laboratory reference methods. Additionally, a study conducted at the Faculty of Medicine in Ain Shams University, Egypt, confirmed the test's robust performance with 97.2% sensitivity, 96.2% specificity, and 96.7% accuracy.
Global and Regional Impact
Globally, approximately 1.4 million new cases of prostate cancer were diagnosed in 2020, resulting in 375,000 deaths1. Prostate cancer is the second most common cancer among men worldwide, with one new case every two minutes2. Over the past decade, 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. While extensive research on prostate cancer has been conducted in Europe and North America, there remains a gap in comprehensive studies within the Middle East.3
Looking Ahead
Biomerica has shipped the first order of the Fortel PSA Screening Tests to its distributors in Saudi Arabia. The company remains committed to expanding its footprint in the region, offering innovative, accessible diagnostic solutions that address the urgent need for early cancer detection.
(accessed 05 Aug 2024)
(accessed 05 Aug 2024)
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. 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.
Source: Biomerica
