Labcorp plans to offer Roche’s recently FDA-cleared blood test to assess early signs of Alzheimer’s disease and other causes of cognitive decline for patients 55 years and older.
The blood test, which is minimally invasive and designed for use in primary care settings, garnered the go-ahead from the FDA in mid-October. The Elecsys pTau181 test was developed in collaboration with Eli Lilly and can help rule out Alzheimer’s-related amyloid pathology.
Currently, about 7.2 million people in the U.S. have Alzheimer’s, and that number is expected to double by 2050, Labcorp said in an Oct. 23 press release. The company will start rolling out the test nationwide early next year.
“Many patients presenting with cognitive symptoms don't have Alzheimer's disease, so helping clinicians rule it out can be just as critical as confirming it," Brian Caveney, M.D., Labcorp’s chief medical and scientific officer, said in the release. “As a leader in neurology with the broadest portfolio of Alzheimer's tests, Labcorp is proud to make the FDA-cleared Elecsys pTau181 test widely available—helping physicians identify the causes of cognitive decline and guide timely, appropriate care.”
The test measures phosphorylated Tau (pTau) 181 protein in human plasma, which is a key biomarker for Alzheimer's pathology, including amyloid plaque and tau aggregate pathology. It received CE mark certification in Europe back in July.
That same month, Quest Diagnostics announced it would offer Fujirebio’s Lumipulse G test to help diagnose Alzheimer’s. Fujirebio’s test, which the FDA cleared in May, measures the ratio between specific tau and beta amyloid proteins found in the bloodstream to identify patients likely to have plaque buildups in the brain without requiring them to undergo brain scans or spinal tap procedures.
A previous version of the Lumipulse G diagnostic received a de novo clearance for testing samples of cerebrospinal fluid.