The Elecsys pTau-217 test identifies amyloid pathology in patients aged 55 and older with cognitive decline symptoms.
Labcorp announced it will offer the Elecsys pTau-217 test following clearance by the Food and Drug Administration (FDA). Developed by Roche Diagnostics, the blood test aids in identifying amyloid pathology associated with Alzheimer disease in individuals 55 and older with signs, symptoms, or complaints of cognitive decline.
The Elecsys pTau-217 is the first and only FDA-cleared single-biomarker blood test to both rule in and rule out amyloid pathology across specialty and primary care settings, according to a Labcorp press release. For many individuals experiencing cognitive decline, evaluation for Alzheimer disease often involves multiple tests, care settings, and healthcare providers.
As blood-based biomarkers for neurological conditions continue to advance, pTau-217 has emerged as a leading biomarker to help clinicians rule in or rule out amyloid pathology in people presenting with symptoms or concerns of cognitive decline. While several pTau-217 assays are commercially available, standardization across care settings remains a consideration for clinicians, according to a release from Roche. The Elecsys pTau-217 test provides a single, standardized assay with the same clinically validated cutoffs across primary and specialty care settings, supporting a consistent approach to patient assessment, according to the release.
“The best advances in Alzheimer’s disease testing should make the diagnostic process simpler, more accessible and more consistent for both patients and clinicians,” says Brian Caveney, chief medical and scientific officer at Labcorp, in a release. “By making the Elecsys pTau-217 test available nationwide, Labcorp is expanding access to innovative blood-based testing and helping clinicians provide more timely assessments and informed next steps for patients.”
Expanding Alzheimer Disease Testing Options
The addition of Elecsys pTau-217 expands the Alzheimer disease testing portfolio at Labcorp. The test joins existing offerings, including the FDA-cleared Elecsys pTau-181 test and the Lumipulse pTau-217/Beta-Amyloid 42 Ratio, according to the company.
Labcorp plans to make the test available nationwide in the coming months.
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