Quest Diagnostics (NYSE: DGX) said it will integrate Roche’s FDA-cleared Elecsys pTau217 plasma test into its AD-Detect portfolio, with a commercial rollout to physicians and clinical trial collaborators scheduled for the fourth quarter of 2026.
The Elecsys Phospho-Tau (217P) Plasma test, cleared by the U.S. Food and Drug Administration on Aug. 24, 2026, is the first FDA-cleared single-assay, single-biomarker blood test for assessing amyloid pathology. Quest will initially offer the test as part of its AD-Detect ABeta 42/40, p-tau217, and ApoE Evaluation panel, which provides a predictive score for Alzheimer’s pathology based on mass spectrometry analysis.
Quest plans to launch the AD-Detect panel by the end of August 2026, with the Roche pTau217 test slated for broader adoption in 2027. The company operates approximately 2,000 patient service centers across the U.S., where patients can access the tests with a physician’s order.
The new testing approach addresses a key clinical need, offering a more efficient and cost-effective alternative to amyloid PET scans for patients with cognitive decline. A study published in the Journal of Prevention of Alzheimer’s Disease by Quest researchers found blood-based biomarker testing to be superior in efficiency and cost compared with PET imaging.
The Elecsys pTau217 test demonstrated a 10% indeterminate rate, below the 15%–20% threshold recommended by the Global CEO Initiative on Alzheimer’s Disease for typical clinical populations. Alzheimer Association guidelines suggest blood-based tests should achieve approximately 90% sensitivity and specificity to confirm Alzheimer’s diagnoses without additional testing.
Quest’s AD-Detect portfolio is designed to expand access to Alzheimer’s pathology screening, with the Roche test expected to enhance early detection capabilities as part of the company’s broader diagnostic offerings.
