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SFDA Approves Breakthrough Biotech Diagnostic Test for Early Alzheimer’s Detection
The Saudi Food and Drug Authority (SFDA) has approved a groundbreaking biotechnology-based in vitro diagnostic test that enables the early detection of Alzheimer’s disease by measuring a specific biomarker in blood plasma.
According to an official statement released today, the newly authorized test delivers results in under 20 minutes by detecting the concentration of the pTau181 protein in a patient’s blood plasma. This marks a major advancement over traditional diagnostic methods, which often require invasive cerebrospinal fluid (CSF) analysis or costly positron emission tomography (PET) scans.
The SFDA confirmed that marketing authorization followed a rigorous scientific evaluation conducted by its experts. The review included a thorough analysis of the device’s technical and clinical documentation, along with clinical trial data, to validate its safety, efficacy, reliability, and diagnostic accuracy.
This approval supports the SFDA’s commitment to advancing the National Biotechnology Strategy and the Health Sector Transformation Program—two pillars of Saudi Vision 2030.
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