Quest Diagnostics , a leading provider of diagnostic information services, has announced plans to offer laboratory testing based on Fujirebio’s Lumipulse® G pTau 217/β-Amyloid 1-42 Plasma Ratio, the first FDA-cleared blood-based in-vitro diagnostic (IVD) test to aid in identifying amyloid pathology associated with Alzheimer’s disease.
Set to become available later this summer, the test will support physicians and biopharmaceutical partners by enhancing clinical evaluation in adults aged 50 and older who exhibit signs of cognitive decline in specialized care settings.
This new offering complements Quest’s AD-Detect™ portfolio, which includes a suite of advanced, CLIA-regulated lab-developed blood tests for Alzheimer’s disease. By adding Fujirebio’s FDA-approved test, Quest is expanding access to validated, minimally invasive diagnostics for early-stage Alzheimer’s evaluation.
“Our mission is to improve access to innovative, blood-based diagnostics for Alzheimer's disease,” said Kathleen Valentine, Vice President and General Manager of Neurology at Quest Diagnostics. “By integrating the Fujirebio test into our broad service network, we empower physicians with more options and help at-risk patients gain earlier, actionable insights.”
In a U.S.-representative clinical study of 499 patients, the test demonstrated a positive predictive value (PPV) of 92% and a negative predictive value (NPV) of 97% when using a dual cut-point approach. Approximately 20% of cases remained inconclusive, warranting additional confirmatory testing.
Quest will feature its full portfolio of neurological diagnostics, including this new test, at the Alzheimer’s Association International Conference (AAIC) in Toronto from July 27–31.
“Diagnosing Alzheimer’s earlier—when treatment is more likely to be effective—is critical,” said Dr. Michael Racke, board-certified neurologist and Medical Director of Neurology at Quest. “Our expanded testing options help physicians make more informed decisions in a cost-effective and patient-friendly way.”
Unlike amyloid PET scans or cerebrospinal fluid (CSF) tests, blood-based diagnostics are significantly less invasive, more affordable, and accessible. Patients can visit any of Quest’s 2,000+ service centers or use mobile/office-based phlebotomy services to provide blood samples. All testing will be performed at Quest’s state-of-the-art facility in San Juan Capistrano, California.
Currently, nearly 7 million Americans are living with Alzheimer’s—a number projected to double by 2060. Between 12–18% of adults over 60 experience mild cognitive impairment, which can be an early sign of Alzheimer’s disease. According to a Quest report, 94% of physicians believe blood tests will reduce costs and 77% expect new treatments to transform Alzheimer’s into a chronic, manageable condition.