Quest Diagnostics' Drug in the FDA Approval Process
This 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.
- Drug:
- AD-Detect
- Announced Date:
- October 27, 2025
- Indication:
- Tests for Alzheimer's Disease Diagnosis
Announcement
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.
AI Summary
Quest 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- Drug:
- AD-Detect
- Announced Date:
- April 9, 2025
- Indication:
- diagnostics for brain health
Announcement
Quest 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 Summary
Quest 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
As of now, Quest Diagnostics (DGX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Quest Diagnostics (DGX) has reported FDA regulatory activity for AD-Detect.
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."
Currently, Quest Diagnostics has one therapy (AD-Detect) targeting the following condition: Tests for Alzheimer's Disease Diagnosis.
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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
FDA progress for NYSE:DGX last updated on 10/27/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
