Saudi Gazette report

RIYADH — The Saudi Food and Drug Authority (SFDA) has approved an innovative biotechnology-based in vitro diagnostic test that detects early signs of Alzheimer’s disease through a simple blood sample.

The test measures the concentration of the pTau181 protein in plasma, a key biomarker linked to Alzheimer’s progression, and delivers results in under 20 minutes.

Regulators said the new tool marks a breakthrough in diagnostics compared with traditional methods, which often rely on invasive spinal taps or costly brain scans.

The SFDA said its authorization followed a comprehensive scientific evaluation, including a review of technical and clinical documentation and study data to confirm the test’s safety, accuracy, and compliance with global standards.

The authority said the approval aligns with Saudi Arabia’s National Biotechnology Strategy and Health Sector Transformation Program under Vision 2030, which seek to expand access to innovative healthcare solutions.

By equipping hospitals and clinics with faster and less invasive tools for diagnosis, the SFDA said the new test will enhance early detection and treatment, ultimately improving patient outcomes and reducing healthcare costs.