Blood-based diagnostic test for Alzheimer’s disease

The U.S. Food and Drug Administration has cleared a blood test capable of diagnosing Alzheimer’s disease.

The decision followed positive results from a clinical study that demonstrated the diagnostic’s high concordance with reference standards among 499 plasma samples, according to the FDA.

The novel blood-based in vitro diagnostic device — which works by detecting amyloid plaques in plasma — is indicated for use among adult patients aged 55 years and older with cognitive symptoms. Though the diagnostic is meant to supplement clinical examination, the test may help reduce the use of unnecessary amyloid positron emission tomography imaging and cerebrospinal fluid testing.

However, the FDA noted that several risks of the novel test include false-positive and -negative results, which may contribute to misdiagnoses and inappropriate treatment.

Read more: FDA

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