Quest Diagnostics to Offer FDA-Cleared Blood Test for Alzheimer's Disease

Quest Diagnostics, a leader in diagnostic information services, announced plans to offer laboratory testing based on the Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio in-vitro diagnostic (IVD) test from Fujirebio. The test is the first blood-based IVD test cleared by the FDA to aid in identifying patients with amyloid pathology associated with Alzheimer's disease. It is designed for adult patients aged 50 years and older with signs of cognitive decline.

Quest will make the test available for clinical and research use later this summer, expanding its AD-Detect™ product line for assessing symptomatic patients. The test demonstrated a positive predictive value of 92% and a negative predictive value of 97% in a clinical study population.

Quest aims to provide innovative blood-based tests for Alzheimer's disease. The addition of the Fujirebio test to its portfolio offers physicians another option for assessing patients. Blood-based testing is less invasive and more convenient than traditional methods, making it easier for at-risk individuals to access necessary insights sooner.

Quest will showcase its Alzheimer's and neurological test innovations at the Alzheimer's Association International Conference in Toronto. The company is committed to developing advanced diagnostics for evaluating Alzheimer's disease and other brain diseases.

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