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Quest Diagnostics Expands Alzheimer’s Testing with Roche pTau217 Assay

Secaucus-based Quest Diagnostics is integrating the newly FDA-cleared Roche Elecsys pTau217 blood test into its AD-Detect portfolio. The move aims to broaden access to diagnostic tools for symptomatic patients, allowing physicians nationwide to assess amyloid pathology using validated clinical cutoffs previously restricted to specialty care settings.

Quest Diagnostics Expands Alzheimer’s Testing with Roche pTau217 Assay

Quest plans to roll out the Roche-based service in the fourth quarter of 2026, with full integration into broader AD-Detect panels scheduled for 2027. This single-biomarker test supports both rule-in and rule-out assessments, providing a streamlined alternative to traditional diagnostic methods like PET-CT scans and cerebrospinal fluid analysis, which often present significant barriers to patient access.

Beyond the Roche collaboration, Quest is launching a proprietary multi-biomarker laboratory-developed test later this month. Combining ABeta 42/40, pTau217, and ApoE evaluation, the panel is designed to increase diagnostic precision. Research published in Neurology Clinical Practice indicates this approach achieves a 10% indeterminate rate, outperforming the 15% to 20% threshold suggested by the Global CEO Initiative on Alzheimer’s Disease. By leveraging its network of 2,000 patient service centers, Quest intends to transition these diagnostics from specialized research environments into standard primary care workflows.

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