Quest announced Wednesday it plans to offer the first FDA-cleared blood-based test for Alzheimer’s disease later this summer.
The Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio test, developed by Fujirebio, is designed to aid in identifying patients with amyloid pathology associated with Alzheimer’s disease. The test is intended for adults aged 50 and older with signs of cognitive decline in specialized care settings.
According to a press release statement, the test demonstrated a positive predictive value of 92% and a negative predictive value of 97% in a clinical study of 499 patients, though 20% of results were uncertain and required additional testing.
"Blood-based testing can be less invasive and more convenient than traditional test methods," said Kathleen Valentine, Vice President and General Manager of Neurology at Quest Diagnostics.
The Fujirebio test will join Quest’s existing AD-Detectâ„¢ portfolio of laboratory-developed blood tests for assessing cognitive impairment. Testing will be conducted at Quest’s laboratory in San Juan Capistrano, California, with blood draws available at approximately 8,000 patient access points nationwide.
Traditional Alzheimer’s diagnostic methods like amyloid PET imaging and cerebrospinal fluid testing are more expensive and invasive than blood tests.
Nearly 7 million Americans have Alzheimer’s disease, with projections reaching 14 million by 2060. Between 12-18% of adults over age 60 live with mild cognitive impairment, a potential early sign of the disease.
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