FDA Events for Personalis (PSNL)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Personalis (PSNL).
Over the past two years, Personalis has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TRACERx. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TRACERx - FDA Regulatory Timeline and Events
TRACERx is a drug developed by Personalis for the following indication: For the Treatment of Lung Cancer.
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:
- TRACERx
- Announced Date:
- January 13, 2025
- Indication:
- For the Treatment of Lung Cancer
Announcement
Personalis, Inc published new results from their TRACERx lung cancer study in Nature Medicine. I
AI Summary
Personalis, Inc recently published new results in Nature Medicine from their TRACERx lung cancer study. The study highlights the importance of using ultra-sensitive tests to detect circulating tumor DNA (ctDNA) in the blood of lung cancer patients. The research focused on early-stage non-small cell lung cancer (NSCLC), analyzing pre-operative blood samples from 171 patients using the NeXT Personal® test. This test showed high sensitivity by detecting ctDNA in 100% of non-adenocarcinomas and 81% of lung adenocarcinomas, a subtype that is typically hard to detect because it releases very low levels of ctDNA.
The study also found that patients with no detectable ctDNA before surgery had a 100% 5-year overall survival rate, while those with positive ctDNA tests experienced a higher risk of relapse. These findings underscore the value of ultra-sensitive ctDNA detection in guiding personalized treatment for lung cancer patients.
Read Announcement
Personalis FDA Events - Frequently Asked Questions
As of now, Personalis (PSNL) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Personalis (PSNL) has reported FDA regulatory activity for TRACERx.
The most recent FDA-related event for Personalis occurred on January 13, 2025, involving TRACERx. The update was categorized as "Results," with the company reporting: "Personalis, Inc published new results from their TRACERx lung cancer study in Nature Medicine. I"
Currently, Personalis has one therapy (TRACERx) targeting the following condition: For the Treatment of Lung Cancer.
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 (NASDAQ:PSNL) was last updated on 7/13/2025 by MarketBeat.com Staff
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