The first FDA-cleared blood test to assess Alzheimer’s disease in primary care is now available for patients age 55 and older with symptoms of cognitive decline.
The test aims to help clinicians rule out Alzheimer’s by identifying individuals unlikely to have amyloid pathology, a protein buildup linked to the disease, according to a Feb. 11 news release from Labcorp, which partners with test developer Roche Diagnostics. It offers a 97.9% negative predictive value and is designed to support early evaluation in primary care settings without the need for brain scans or lumbar punctures.
The test, cleared by the FDA in 2025, can be performed via blood draw in a physician’s office or at one of more than 2,200 patient service centers across the U.S. Patients with negative results can be assessed for other causes of cognitive decline, while those with positive results may be referred for further testing.
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