The Saudi Food and Drug Authority (SFDA) Approves Biomerica's At Home PSA Screening Test to Detect Early Signs of Prostate Cancer

Core Insights - Biomerica, Inc. has received approval from the Saudi Food and Drug Authority for its Fortel® Prostate (PSA) Screening Test, enabling at-home early detection of prostate cancer [1][3] - The Fortel® PSA test is a rapid diagnostic tool that provides results within 10 minutes using a simple finger-prick blood sample, making it accessible for men [2] - The company is strategically expanding into the Middle East, addressing the growing public health concern of prostate cancer in the region [3] Product Performance - The Fortel® PSA test has shown exceptional performance with 100% sensitivity, 95% specificity, and 97.5% accuracy compared to laboratory methods [4] - A study from Ain Shams University in Egypt confirmed the test's robust performance with 97.2% sensitivity, 96.2% specificity, and 96.7% accuracy [4] Market Context - Globally, approximately 1.4 million new cases of prostate cancer were diagnosed in 2020, leading to 375,000 deaths, making it the second most common cancer among men [5] - Prostate cancer is increasingly recognized as a significant public health challenge in the Middle East, with a noted gap in comprehensive studies compared to Europe and North America [5] Future Outlook - Biomerica has shipped its first order of the Fortel® PSA Screening Tests to distributors in Saudi Arabia and is committed to expanding its presence in the region [6]