The USFDA has approved the first blood-based in vitro diagnostic test for detecting Alzheimer’s disease in symptomatic patients aged 55 years and older. The test uses an automated immunoassay instrument to measure plasma concentrations of pTau 217 and β-amyloid 1-42, aiding in the detection of β-amyloid plaque accumulation in the brain. Clinical evidence In a clinical trial involving 499 patients, the test detected amyloid plaques in 91.7% of individuals, compared to 97.3% with PET scans or cerebrospinal fluid tests. Diagnostic test Reduces the need for a PET scan.
Indicated for patients with signs and symptoms of cognitive decline The results must be interpreted in conjunction with other clinical information. May produce false-positive and false-negative test results Received Breakthrough Device designation Did you find this FDA Alert interesting? Source : FDA ##Disclaimer## The…
