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
NeXT and TRACERx. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
NeXT Personal FDA Regulatory Timeline and Events
NeXT Personal is a drug developed by Personalis for the following indication: in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).
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:
- NeXT Personal
- Announced Date:
- April 13, 2026
- Indication:
- in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Announcement
Personalis, Inc announced today that an oral podium presentation featuring colorectal cancer data for the company's NeXT Personal ultrasensitive ctDNA assay and three posters will be presented at the American Association for Cancer Research (AACR) Annual Meeting April 17-22, 2026, in San Diego, California.
AI Summary
Personalis, Inc announced today that an oral podium presentation featuring colorectal cancer data for the company’s NeXT Personal ultrasensitive ctDNA assay, plus three posters, will be presented at the American Association for Cancer Research (AACR) Annual Meeting April 17–22, 2026, in San Diego, California. The presentations will report new clinical data and methods using the company’s MRD testing platform.
A focus of this year’s data is a new NeXT Personal MRD test option called Real‑Time Variant Tracker. This first‑of‑its‑kind feature in tumor‑informed clinical MRD testing is designed to longitudinally track therapy resistance mutations over time, helping clinicians see emerging resistance as patients receive treatment.
The planned oral presentation and posters aim to highlight the use and clinical impact of the ultrasensitive NeXT Personal MRD test—its ability to detect minimal residual disease, monitor patient response, and potentially inform treatment decisions based on evolving tumor mutations.Read Announcement
- Drug:
- NeXT Personal
- Announced Date:
- February 2, 2026
- Indication:
- in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Announcement
Personalis, Inc. announced the publication of a new study in npj Precision Oncology highlighting the power of its ultrasensitive molecular residual disease (MRD) assay, NeXT Personal®, in monitoring immunotherapy response across a broad range of advanced cancers.
AI Summary
Personalis, Inc. announced a new study in npj Precision Oncology showing its ultrasensitive molecular residual disease (MRD) assay, NeXT Personal®, can monitor immunotherapy response across many advanced cancers. The study, led by researchers at UC San Diego Moores Cancer Center, looked at 39 patients with advanced solid tumors spanning nine cancer types who were treated with immune checkpoint inhibitors alone or with other therapies. The report notes that only about 10–40% of patients get lasting benefit from immunotherapy, so better tools to track response are needed.
The interim analysis found that ctDNA-based MRD monitoring with NeXT Personal revealed early predictors of who was responding to treatment. By detecting molecular signs of response or resistance sooner, the assay could help clinicians make timelier treatment decisions for patients with advanced cancer. The findings come from an ongoing study and suggest broad utility for ultrasensitive ctDNA monitoring in immunotherapy care.
Read Announcement- Drug:
- NeXT Personal
- Announced Date:
- October 16, 2025
- Indication:
- in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).
Announcement
Personalis, Inc. announced new data from an AstraZeneca phase 3 clinical trial in lung cancer (LAURA).
Read Announcement
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:
- February 10, 2026
- Indication:
- For the Treatment of Lung Cancer
Announcement
Personalis, Inc announced Medicare coverage for the company's NeXT Personal molecular residual disease (MRD) test for surveillance of patients with Stage I to III non-small cell lung cancer (NSCLC).
AI Summary
Personalis, Inc. announced that Medicare will cover its NeXT Personal molecular residual disease (MRD) test for surveillance of patients with Stage I to III non-small cell lung cancer (NSCLC). The coverage is supported by data from the landmark TRACERx collaboration and expands access for Medicare patients who need ongoing monitoring after initial treatment. This decision aims to make the test more available to clinicians and survivors concerned about cancer returning.
NeXT Personal uses whole-genome sequencing and advanced noise-suppression to reach ultrasensitive detection. It can track roughly 1,800 mutations that create a unique tumor fingerprint, which helps find tiny amounts of circulating tumor DNA (ctDNA) even when shedding is low. Personalis says the test gives clinicians a more consistent tool for tracking recurrence and residual disease, helping patients and doctors manage uncertainty during follow-up care.
Read Announcement- Drug:
- TRACERx
- Announced Date:
- December 11, 2025
- Indication:
- For the Treatment of Lung Cancer
Announcement
Personalis, Inc. announced the publication of one of the largest and most comprehensive patient cohorts to date from the landmark TRACERx study, in the journal Cell.
AI Summary
Personalis announced that a major TRACERx study was published in Cell, titled “Longitudinal ultrasensitive ctDNA monitoring for high-resolution lung cancer risk prediction.” Led by Professor Charles Swanton with collaborators at the Francis Crick Institute, UCL and Personalis, the analysis tracked 431 non-small cell lung cancer patients for a median of more than five years using the NeXT Personal® test. The test uses whole-genome sequencing and noise suppression to detect circulating tumor DNA (ctDNA) at extremely low levels (around 1 part per million).
The study found NeXT Personal detected cancer from diagnosis through long-term surveillance, with roughly 36–43% of detections in an ultrasensitive range that other tests can miss. ctDNA appeared a median of about 5–9 months — and up to 57 months — before imaging. Detectable ctDNA before or after treatment was linked to higher relapse risk and worse survival; patients who didn’t clear ctDNA during adjuvant chemo were over five times more likely to relapse. The results support ultrasensitive, tumor-informed MRD testing to guide follow-up and treatment decisions.
Read Announcement- 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
