Quest Diagnostics to Launch FDA-Cleared Blood Test for Alzheimer Disease Assessment

Quest Diagnostics (Secaucus, NJ) announced plans to begin offering the Lumipulse G pTau 217/β-Amyloid 1-42 diagnostic test (Fujirebio Diagnostics, Malvern, PA) later in the summer of 2025 to physicians and biopharmaceutical collaborators. The Lumipulse test is the first Food and Drug Administration (FDA)-cleared blood-based diagnostic tool for Alzheimer disease (AD). This in vitro diagnostic measures the plasma ratio of phosphorylated tau217 (p-tau217) to β-amyloid 1-42 and is intended to aid in identifying amyloid pathology in adults aged >50 years who are showing signs of cognitive decline.

According to a statement from Quest Diagnostics, the ability of the Lumipulse test to evaluate amyloid pathology using a blood draw allows for easier, more scalable access to AD testing compared with other methods such as cerebrospinal fluid (CSF) and positron emission tomography (PET) tests. After a physician orders a test, patients will report for a blood draw at a site within Quest Diagnostic’s network, and test results will be processed at the company’s San Juan Capistrano laboratory.

The FDA’s decision to clear the Lumipulse test was based on data from a multicenter clinical study that included plasma samples from 499 adult participants with cognitive impairment. Investigators compared results from the Lumipulse diagnostic test to results from amyloid PET or CSF biomarker tests.

• 91.7% of individuals with a positive plasma test had amyloid pathology confirmed via PET or CSF biomarker testing.
• 97.3% of individuals with a negative plasma test had no evidence of amyloid pathology confirmed via PET or CSF biomarker testing.
• <20% of participants received indeterminate results from the plasma test.

“As brain health and Alzheimer's disease interventions continue to evolve, diagnosing patients earlier, when interventions can be most effective, is critical,” said Michael Racke, MD, a board-certified Neurologist and the Medical Director of Neurology at Quest Diagnostics. “We are constantly looking for ways to help physicians and patients make the most informed decisions, and this new addition to our test menu will aid that goal.”