FDA Events for Quest Diagnostics (DGX)
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 Timeline and Events
AD-Detect is a drug developed by Quest Diagnostics for the following indication: diagnostics for brain health.
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:
- 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 April 9, 2025, involving AD-Detect. The update was categorized as "Provided Update," with the company reporting: "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."
Currently, Quest Diagnostics has one therapy (AD-Detect) targeting the following condition: diagnostics for brain health.
More FDA Event Resources from MarketBeat
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
This page (NYSE:DGX) was last updated on 7/10/2025 by MarketBeat.com Staff
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