Quest Diagnostics to Offer FDA-Cleared Roche pTau217 Blood Test to Assess Alzheimer's Disease Pathology

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  "company": {
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    "url": "https://www.prnewswire.com/news-releases/quest-diagnostics-to-offer-fda-cleared-roche-ptau217-blood-test-to-assess-alzheimers-disease-pathology-302858247.html",
    "title": "Quest Diagnostics to Offer FDA-Cleared Roche pTau217 Blood Test to Assess Alzheimer's Disease Pathology",
    "excerpt": "Test to join the company's expansive portfolio of Quest AD-Detect® blood tests for assessing symptomatic patients Quest also launching a new multi-biomarker AD-Detect® lab-developed blood test with low 10% indeterminate rate, so more patients can receive an actionable insight SECAUCUS, N.J. , Aug. 24, 2026 /PRNewswire/ -- Quest Diagnostics (NYSE: DGX ), a leader in diagnostic information services, today announced two new developments for its Quest AD-Detect® portfolio of blood-based biomarker tests for Alzheimer's disease, with the goal of broadening access to quality blood tests for evaluating symptomatic patients for Alzheimer's disease. Adding the FDA-cleared Elecsys pTau217 test to the AD-Detect™ portfolio Earlier today, Roche announced that the U.S. Food and Drug Administration (FDA) has cleared the Elecsys® Phospho-Tau (217P) Plasma (pTau217) blood test, making it the first and only FDA-cleared single-assay, single-biomarker blood biomarker test that supports both rule-in and rule-out assessment of amyloid pathology using the same validated clinical cutoffs across primary and specialty care settings. Quest provides a comprehensive menu of blood-based Alzheimer's biomarker tests under the AD-Detect™ brand name. Quest plans to introduce an AD-Detect-branded laboratory test service based on the FDA-cleared Elecsys® pTau217 assay to physicians and clinical trials...",
    "product": "AD-Detect-branded laboratory test service",
    "summary": "Quest Diagnostics plans to launch a laboratory test service based on Roche's FDA-cleared Elecsys pTau217 assay in the fourth quarter of 2026.",
    "location": "United States",
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    "published_at": "2026-08-24T11:24:00Z",
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    "related_company_name": "Roche",
    "related_company_domain": "roche.com"
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