US laboratory services company Labcorp Holdings, Inc. (NYSE: LH) announced on Monday that, following US Food and Drug Administration clearance, it will offer the Elecsys pTau-217 test nationwide.
Developed by Roche Diagnostics, the blood test measures phosphorylated Tau 217, an indicator of amyloid pathology associated with Alzheimer's disease in people aged 55 and older presenting with cognitive decline.
Elecsys pTau-217 is a single-biomarker blood test able to both rule in and rule out amyloid pathology across primary and specialty care settings. It is designed to provide a single, standardised assay with clinically validated cut-offs, addressing variability across commercially available pTau-217 tests.
The test offers positive, intermediate and negative result categories and delivers performance comparable to cerebrospinal fluid testing and positron emission tomography imaging. Once ordered, blood samples can be drawn in a clinician's office or at one of Labcorp's 2,200+ patient service centres, with results interpreted alongside clinical information as part of a broader evaluation.
The test will join the company's existing Alzheimer's portfolio, including the FDA-cleared Elecsys pTau-181 test and the Lumipulse pTau-217/Beta-Amyloid 42 Ratio.
Labcorp plans to make Elecsys pTau-217 available across the United States in the coming months.
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