FDA Approves First Blood Test for Alzheimer’s Diagnosis From Age 40

The U.S. Food and Drug Administration (FDA) has approved PrecivityAD2, a blood test designed to aid in diagnosing Alzheimer’s disease in adults aged 40 and older who exhibit symptoms such as memory decline or cognitive impairment. Developed by C2N Diagnostics, the test uses mass spectrometry technology to measure proteins in the blood linked to Alzheimer’s, including various forms of beta-amyloid and tau proteins. These measurements are analyzed by an algorithm that estimates the likelihood of amyloid deposits in the brain.

The test demonstrated high accuracy in a study involving 1,142 individuals with cognitive decline, showing a 97.6% positive predictive value and 93.1% negative predictive value, maintaining reliability even among patients with common comorbidities. Dr. Talia Natan, a senior physician in the cognitive neurology unit at Ichilov Medical Center, highlighted the test as a significant advancement that could revolutionize the diagnosis and management of neurodegenerative brain diseases. She emphasized that using biological markers instead of invasive procedures like lumbar punctures dramatically shortens the critical diagnostic process, which is essential in the era of disease-modifying treatments.

The PrecivityAD2 test is not intended for screening asymptomatic individuals and does not replace comprehensive medical evaluation. It is expected to become available in the United States later this year, with no set date for its introduction in Israel. Researchers at the University of Washington noted that lowering the age threshold for testing could also benefit clinical trials, as brain changes may occur decades before symptoms appear.