Quanterix's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Quanterix (QTRX).
Over the past two years, Quanterix has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Simoa. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Simoa p-Tau 217 FDA Regulatory Events
Simoa p-Tau 217 is a drug developed by Quanterix for the following indication: Redefining Alzheimer's Disease Neuropathology Prevalence.
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:
- Simoa p-Tau 217
- Announced Date:
- December 22, 2025
- Indication:
- Redefining Alzheimer's Disease Neuropathology Prevalence
Announcement
Quanterix Corporation announced publication of a landmark study in the prestigious journal Nature.
AI Summary
Quanterix Corporation announced publication of a landmark study in Nature that used its ultra‑sensitive Simoa p‑Tau 217 (phosphorylated tau at threonine 217) research assay to perform the largest population‑based assessment of Alzheimer’s disease neuropathology to date. Researchers analyzed more than 11,000 Norwegian adults aged 58 and older and found AD neuropathological change (ADNC) rises sharply with age — about 10% in ages 58–69.9 and 64.9% in those over 90. Among people 70 and older, 30.4% showed ADNC: 11.4% preclinical AD, 10.8% prodromal AD, and 7.4% AD dementia. The study also estimates roughly 10% of the 70+ population meet current treatment eligibility and links AD pathology to sex, APOE genotype, and education.
The findings relied on a validated commercial p‑Tau 217 kit (ALZpath p‑Tau‑217 Advantage PLUS) run on a fully automated HD‑X analyzer. Quanterix says its Simoa platform enabled scalable, sensitive blood measurements that make population‑level screening and planning for treatments and trials more feasible.
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Quanterix FDA Events - Frequently Asked Questions
As of now, Quanterix (QTRX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Quanterix (QTRX) has reported FDA regulatory activity for Simoa p-Tau 217.
The most recent FDA-related event for Quanterix occurred on December 22, 2025, involving Simoa p-Tau 217. The update was categorized as "Publication," with the company reporting: "Quanterix Corporation announced publication of a landmark study in the prestigious journal Nature."
Currently, Quanterix has one therapy (Simoa p-Tau 217) targeting the following condition: Redefining Alzheimer's Disease Neuropathology Prevalence.
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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 NASDAQ:QTRX last updated on 12/22/2025 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
