Quest to offer FDA-approved Alzheimer’s blood test

Dawn Furnas//July 11, 2025//

Secaucus-based Quest Diagnostics performs diagnostic testing.

Secaucus-based Quest Diagnostics - PROVIDED BY QUEST

Secaucus-based Quest Diagnostics performs diagnostic testing.

Secaucus-based Quest Diagnostics - PROVIDED BY QUEST

Quest to offer FDA-approved Alzheimer’s blood test

Dawn Furnas//July 11, 2025//

Listen to this article

will soon begin offering a new blood-based in-vitro diagnostic test for Alzheimer’s. The disease affects nearly 7 million Americans. 

The Lumipulse G pTau 217/β-Amyloid 1-42 Plasma Ratio IVD test from Fujirebio is the first blood-based IVD test approved by the U.S. Food and Drug Administration to aid in identifying patients with amyloid pathology associated with Alzheimer’s. 

The test will be available to physicians and biopharmaceutical collaborators later this summer, the Secaucus-based laboratory testing company announced July 9. 

It is designed to aid the clinical assessment of Alzheimer’s in adults age 50 and older presenting at a specialized care setting with signs and symptoms of cognitive decline. 

The new test builds on Quest’s portfolio of diagnostic tools for assessing patients with cognitive impairment for . Quest added that about 12% to 18% of adults over age 60 are living with mild cognitive impairment, a potential sign of Alzheimer’s.

Cutting costs

According to a May 2022 Quest report, 94% of physicians say blood tests would be a more cost-effective as well as less-invasive method of Alzheimer’s detection, compared with options such as lumbar puncture and imaging studies. 

“Our goal is to advance access to quality and innovative blood-based tests for Alzheimer’s disease. Adding the Fujirebio test to our existing blood-based tests provides the many physicians we serve with another powerful option for assessing patients for Alzheimer’s disease,” Kathleen Valentine, Quest’s vice president and general manager, Neurology, said in a statement.  

Dr. Michael Racke, Quest’s medical director of neurology, said, “As brain health and Alzheimer’s disease interventions continue to evolve, diagnosing patients earlier, when interventions can be most effective, is critical. 

“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,” Racke added.