Biomerica has secured approval from the UAE Ministry of Health and Prevention (MOHAP) for its Fortel prostate-specific antigen (PSA) screening test, designed for the early detection of prostate cancer. This approval marks a significant step in enhancing diagnostic capabilities in the region.
The Fortel PSA test employs a simple finger-prick blood sample to rapidly assess elevated PSA levels, a key indicator of early-stage prostate cancer. The test provides results within ten minutes, offering a convenient and quick screening method.
Clinical Performance
Biomerica reports that the Fortel test has demonstrated promising results in clinical evaluations. One study showed a sensitivity of 100%, a specificity of 95%, and an accuracy of 97.5%. Further validation at Ain Shams University's Faculty of Medicine in Egypt revealed a sensitivity of 97.2%, a specificity of 96.2%, and an accuracy of 96.7%.
Impact and Accessibility
The introduction of the Fortel test aims to alleviate pressure on healthcare systems by enabling early identification of prostate cancer, potentially leading to improved patient outcomes. Biomerica is also pursuing government insurance reimbursement for the Fortel test, following the precedent set by its EZ Detect colon disease at-home screening test in Dubai.
Biomerica is actively establishing partnerships with distributors and securing necessary regulatory approvals to facilitate the widespread adoption of the Fortel test in the region. The company continues to focus on developing accessible, accurate, and affordable diagnostic tools for early disease detection and treatment.
