The U.S. Food and Drug Administration (FDA) has cleared for marketing a blood test for the early diagnosis of Alzheimer's disease, with underlying technology invented at Washington University School of Medicine in St. Louis. The test, known as the PrecivityAD test, measures specific biomarkers in the blood that are associated with Alzheimer's pathology.
According to the FDA announcement, the test is intended for use in adults aged 55 and older who are experiencing cognitive impairment and are being evaluated for Alzheimer's disease. It is not a standalone diagnostic tool but should be used in conjunction with other clinical assessments.
The clearance was based on clinical data demonstrating the test's accuracy in detecting amyloid plaques in the brain, a hallmark of Alzheimer's. The test has been available as a laboratory-developed test (LDT) since 2020, but this FDA clearance provides a higher level of regulatory oversight and may expand its use in clinical settings.
Experts note that early detection of Alzheimer's could enable earlier intervention and better management of the disease. However, they caution that the test is not a cure and should be used as part of a comprehensive diagnostic process.
