SFDA Approves Innovative Biotechnology-Based Diagnostic Test for the Early Detection of Alzheimer's Disease

   Riyadh, September 01, 2025, SPA -- The Saudi Food and Drug Authority (SFDA) has approved an innovative biotechnology-based in vitro diagnostic test designed to aid in the early detection of Alzheimer's disease by measuring a specific biomarker in blood plasma.
   According to a press release issued by the SFDA today, introducing a faster and more accurate diagnostic solution, this diagnostic test measures the concentration of the pTau181 protein in a patient’s blood plasma, providing accurate results in under 20 minutes. This innovative technology marks a significant improvement over traditional diagnostic methods for Alzheimer's disease, which often involve invasive and time-consuming procedures such as cerebrospinal fluid (CSF) analysis or expensive positron emission tomography (PET) scans.
   The SFDA confirmed that the marketing authorization was granted after the device underwent a comprehensive scientific evaluation by its experts.
   The release added that this review included a detailed assessment of the device’s technical and clinical documentation, as well as clinical study data, to confirm its safety, efficacy, reliability, and diagnostic accuracy.
   The authorization aligns with the SFDA’s strategic objectives to advance the National Biotechnology Strategy and the Health Sector Transformation Program, both of which are key components of Saudi Vision 2030.
   -- SPA