Saudi Arabia’s Food and Drug Administration (SFDA) approves Biomerica’s home PSA screening test to detect early signs of prostate cancer Page 1

– 10-Minute 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 worldwide

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 for sale and use in the country. This at-home test is designed to enable men to detect early warning signs of prostate cancer from the comfort of their own home.

The Fortel Prostate (PSA) At-Home Screening Test is an easy-to-use, rapid diagnostic tool that measures elevated PSA, an early indicator of prostate disease, including cancer. The test uses a simple fingerstick blood sample and delivers highly accurate results in 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. Committed to making early detection more accessible, Biomerica has established partnerships with leading distributors, secured key regulatory approvals and received insurance reimbursements from the Government of Dubai for its EZ Detect Colon Disease 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. One study reported 100% sensitivity, 95% specificity, and 97.5% accuracy compared to laboratory reference methods. In addition, a study conducted at the Faculty of Medicine, Ain Shams University in Egypt confirmed the robust performance of the test with 97.2% sensitivity, 96.2% specificity, and 96.7% accuracy.

Global and regional impact

Approximately 1.4 million new cases of prostate cancer were diagnosed worldwide in 2020, resulting in 375,000 deaths¹Prostate cancer is the second most common cancer in men worldwide, with one new case diagnosed every two minutes.². In the past decade, prostate cancer has been increasingly recognized as a major public health challenge in the Middle East. The disease varies in prevalence and severity across regions, age groups, ethnicities, and races. Although extensive research on prostate cancer has been conducted in Europe and North America, there is still a gap in comprehensive studies in the Middle East.³