Quest Diagnostics (DGX) FDA Approvals $194.17 +1.01 (+0.52%) Closing price 03:58 PM EasternExtended Trading$194.05 -0.12 (-0.06%) As of 06:32 PM Eastern Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Massive. Learn more. Add Compare Share Share FDA Events Stock AnalysisAnalyst ForecastsChartCompetitorsDividendEarningsFDA EventsFinancialsHeadlinesInsider TradesOptions ChainOwnershipSEC FilingsShort InterestTrendsBuy This Stock Quest Diagnostics' Drug in the FDA Approval ProcessThis section highlights FDA-related milestones and regulatory updates for drugs developed by Quest Diagnostics (DGX). Over the past two years, Quest Diagnostics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as AD-Detect. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. AD-Detect FDA Regulatory Events AD-Detect is a drug developed by Quest Diagnostics for the following indication: Tests for Alzheimer's Disease Diagnosis. This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy. Provided Update - October 27,2025Provided Update Drug: AD-DetectAnnounced Date: October 27, 2025Indication: Tests for Alzheimer's Disease DiagnosisAnnouncementQuest Diagnostics announced that Two blood tests, each involving multiple biomarkers, are highly accurate at identifying Alzheimer's disease pathology in symptomatic patients, supporting diagnosis, according to a new study in Neurology® Clinical Practice, a publication of the American Academy of Neurology.AI SummaryQuest Diagnostics scientists and University of Florida researchers studied two blood tests that each measure multiple biomarkers to detect Alzheimer’s pathology in symptomatic patients. Published in Neurology Clinical Practice, the study showed both panels achieved 91% sensitivity and 91% specificity, matching recommended standards for confirmatory testing without follow-up PET scans or cerebrospinal fluid analysis. One panel combines amyloid beta 42/40, phosphorylated tau 217, and ApoE4 proteotype, yielding a positive predictive value of 88% and a negative predictive value of 91%. A second panel without ApoE4 scored 87% PPV and 91% NPV. Indeterminate rates were as low as 10% with all three markers and 15% without ApoE4, meeting guideline limits. These scalable blood tests could reduce reliance on expensive or invasive imaging, offering physicians an accurate tool to support Alzheimer’s diagnosis in patients with mild cognitive impairment or Alzheimer’s disease symptoms.Read AnnouncementProvided Update - April 9,2025Provided Update Drug: AD-DetectAnnounced Date: April 9, 2025Indication: diagnostics for brain healthAnnouncementQuest Diagnostics announced the launch of a new laboratory blood test designed to help physicians confirm amyloid brain pathology due to Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or dementia.AI SummaryQuest Diagnostics has recently launched a new laboratory blood test, AD-Detect™ Abeta 42/40 and p-tau217 Evaluation, designed to help physicians confirm amyloid brain pathology linked to Alzheimer’s disease. This innovative tool targets patients with mild cognitive impairment or dementia by detecting key proteins, amyloid beta (AB) 42/40 and p-tau217, in the blood. The test uses Quest’s proprietary tandem mass spectrometry and immunoassay techniques to generate an AD-Detect Likelihood Score through a unique algorithm. Data presented at the 2025 American Academy of Neurology Annual Meeting indicated that the test can identify Alzheimer’s pathology with over 90% sensitivity and specificity. Incorporating the ApoE genetic marker further improved its predictive value, offering a reliable, less invasive option compared to traditional PET scans or lumbar punctures. This development could make Alzheimer’s evaluation more accessible, affordable, and faster for patients in need.Read Announcement Quest Diagnostics FDA Events - Frequently Asked Questions Has Quest Diagnostics received FDA approval? As of now, Quest Diagnostics (DGX) has not received any FDA approvals for its therapy in the last two years. What drugs has Quest Diagnostics submitted to the FDA? In the past two years, Quest Diagnostics (DGX) has reported FDA regulatory activity for AD-Detect. What is the most recent FDA event for Quest Diagnostics? The most recent FDA-related event for Quest Diagnostics occurred on October 27, 2025, involving AD-Detect. The update was categorized as "Provided Update," with the company reporting: "Quest Diagnostics announced that Two blood tests, each involving multiple biomarkers, are highly accurate at identifying Alzheimer's disease pathology in symptomatic patients, supporting diagnosis, according to a new study in Neurology® Clinical Practice, a publication of the American Academy of Neurology." What conditions do Quest Diagnostics' current drugs treat? Currently, Quest Diagnostics has one therapy (AD-Detect) targeting the following condition: Tests for Alzheimer's Disease Diagnosis. More FDA Event Resources from MarketBeat FDA Calendars Recent FDA Drug Approval Calendar Upcoming FDA Events & PDUFA Dates Calendar Companies With Recent FDA Events argenex FDA EventsAxsome Therapeutics FDA EventsBiogen FDA EventsCabaletta Bio FDA EventsDyne Therapeutics FDA EventsFibroBiologics FDA EventsIDEAYA Biosciences FDA EventsLexicon Pharmaceuticals FDA EventsMannKind FDA EventsInsulet FDA EventsTG Therapeutics FDA EventsTenaya Therapeutics FDA EventsJohnson & Johnson FDA EventsCandel Therapeutics FDA EventsCelcuity FDA Events FDA Event Stage Terminology & Abbreviation Guide NDA: New Drug Application ANDA: Abbreviated New Drug Application sNDA: Supplemental New Drug Application BLA: Biologics License Application sBLA: Supplemental Biologics License Application FDA Approved: Approved by the FDA EMA: European Medicines Agency CE Mark: European Union Certification NMPA: China National Medical Products Administration MHLW: Japanese Ministry of Health FDA Meeting: Consultation with FDA Pre-IND: Pre-Investigational New Drug Meeting Breakthrough Therapy: Special FDA designation for promising therapies Fast Track: Accelerated FDA approval pathway Orphan Drug: Designation for rare disease treatments RPD: Rare Pediatric Disease Designation RMAT: Regenerative Medicine Advanced Therapy DSMB Review: Data Safety Monitoring Board Review IDMC Review: Independent Data Monitoring Committee MAA: MHRA Marketing Authorization Application RTF: Refusal to File (Rejected Application) 510(k): FDA Clearance for Medical Devices Rolling Submission: Staggered regulatory review process Related Companies Labcorp FDA Events Elanco Animal Health FDA Events Atai Beckley FDA Events Boston Scientific FDA Events Regeneron Pharmaceuticals FDA Events argenex FDA Events Takeda Pharmaceutical FDA Events Cardinal Health FDA Events Teva Pharmaceutical Industries FDA Events Becton, Dickinson and Company FDA Events Stock Lists Biotechnology StocksCompare Biotech StocksCompare Healthcare StocksCompare Pharmaceutical StocksHealthcare and Medical Stocks FDA progress for NYSE:DGX last updated on 10/27/2025 by MarketBeat.com Staff. 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Provided Update - October 27,2025Provided Update Drug: AD-DetectAnnounced Date: October 27, 2025Indication: Tests for Alzheimer's Disease DiagnosisAnnouncementQuest Diagnostics announced that Two blood tests, each involving multiple biomarkers, are highly accurate at identifying Alzheimer's disease pathology in symptomatic patients, supporting diagnosis, according to a new study in Neurology® Clinical Practice, a publication of the American Academy of Neurology.AI SummaryQuest Diagnostics scientists and University of Florida researchers studied two blood tests that each measure multiple biomarkers to detect Alzheimer’s pathology in symptomatic patients. Published in Neurology Clinical Practice, the study showed both panels achieved 91% sensitivity and 91% specificity, matching recommended standards for confirmatory testing without follow-up PET scans or cerebrospinal fluid analysis. One panel combines amyloid beta 42/40, phosphorylated tau 217, and ApoE4 proteotype, yielding a positive predictive value of 88% and a negative predictive value of 91%. A second panel without ApoE4 scored 87% PPV and 91% NPV. Indeterminate rates were as low as 10% with all three markers and 15% without ApoE4, meeting guideline limits. These scalable blood tests could reduce reliance on expensive or invasive imaging, offering physicians an accurate tool to support Alzheimer’s diagnosis in patients with mild cognitive impairment or Alzheimer’s disease symptoms.Read Announcement
Provided Update - April 9,2025Provided Update Drug: AD-DetectAnnounced Date: April 9, 2025Indication: diagnostics for brain healthAnnouncementQuest Diagnostics announced the launch of a new laboratory blood test designed to help physicians confirm amyloid brain pathology due to Alzheimer's disease (AD) in patients with mild cognitive impairment (MCI) or dementia.AI SummaryQuest Diagnostics has recently launched a new laboratory blood test, AD-Detect™ Abeta 42/40 and p-tau217 Evaluation, designed to help physicians confirm amyloid brain pathology linked to Alzheimer’s disease. This innovative tool targets patients with mild cognitive impairment or dementia by detecting key proteins, amyloid beta (AB) 42/40 and p-tau217, in the blood. The test uses Quest’s proprietary tandem mass spectrometry and immunoassay techniques to generate an AD-Detect Likelihood Score through a unique algorithm. Data presented at the 2025 American Academy of Neurology Annual Meeting indicated that the test can identify Alzheimer’s pathology with over 90% sensitivity and specificity. Incorporating the ApoE genetic marker further improved its predictive value, offering a reliable, less invasive option compared to traditional PET scans or lumbar punctures. This development could make Alzheimer’s evaluation more accessible, affordable, and faster for patients in need.Read Announcement
