Personalis Announces New Data from a Landmark Lung Cancer Trial Utilizing Ultrasensitive MRD Testing

FREMONT, Calif.--(BUSINESS WIRE)--Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, announced new data from an AstraZeneca phase 3 clinical trial in lung cancer (LAURA). The findings demonstrate that Personalis’ highly sensitive molecular residual disease (MRD) test, NeXT Personal®, is a useful tool in assessing the maintenance treatment response post-CRT in patients with unresectable stage III, EGFR-mutated (EGFRm) non-small cell lung cancer (NSCLC).

The new LAURA analysis will be presented at the ESMO 2025 Conference in Berlin, Germany, demonstrating key findings for NeXT Personal:

• Treatment monitoring: Osimertinib treatment led to MRD clearance in most patients with post-chemoradiotherapy (post-CRT) MRD, demonstrating the utility of ctDNA for monitoring the maintenance therapy response
• Lead time to progression: NeXT Personal detected MRD progression with a median lead time of 5 months ahead of Blinded Independent Central Review (BICR) assessed disease progression

“This study from AstraZeneca shows how ultrasensitive ctDNA detection enabled by NeXT Personal enables precise tracking of the maintenance treatment response post-CRT during clinical trials. It is a good example of how AstraZeneca and our other biopharma partners are taking advantage of our ultrasensitive assay to gain new insights into their clinical studies,” said Richard Chen, Chief Medical Officer and EVP of R&D at Personalis.

The LAURA trial (NCT03521154) is a global, randomized, placebo-controlled, double-blind, multi-center study of osimertinib following chemoradiation for patients with unresectable EGFRm NSCLC.

This collaboration also builds on previous work with AstraZeneca, showing the importance of highly sensitive ctDNA analysis for tracking treatment response and predicting cancer recurrence. This includes a recent publication of Phase 3 CALLA cervical cancer study results showing that NeXT Personal detected traces of cancer DNA in patients with locally advanced cervical cancer up to ~16 months ahead of standard of care imaging, and a recent presentation at the IASLC 2025 World Conference on Lung Cancer on the NeoADAURA study demonstrating that NeXT Personal can be a more sensitive and accurate measure of MRD in the neoadjuvant setting.

About Personalis, Inc.

At Personalis, we are transforming the active management of cancer through breakthrough personalized testing. We aim to drive a new paradigm for cancer management, guiding care throughout the patient journey. Our highly sensitive assays combine tumor-and-normal profiling with proprietary algorithms to deliver advanced insights even as cancer evolves over time. Our products are designed to detect minimal residual disease (MRD) and recurrence at the earliest timepoints, enable selection of targeted therapies based on ultracomprehensive genomic profiling, and enhance biomarker strategy for drug development. Personalis is based in Fremont, California. To learn more, visit www.personalis.com and connect with us on LinkedIn and X (Twitter).

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements in this press release that are not historical are “forward-looking statements” within the meaning of U.S. securities laws, including statements relating to the attributes, advantages, sensitivity or clinical relevance of the NeXT Personal test or to the potential impact or expected benefits of the LAURA study. Such forward-looking statements involve known and unknown risks and uncertainties and other factors that may cause actual results to differ materially from any anticipated results or expectations expressed or implied by such statements, including the risks, uncertainties and other factors that relate to the ability of NeXT Personal to detect small traces of ctDNA, detect residual or recurrent cancer early, or impact cancer care or management (including for escalation or de-escalation of treatment). These and other potential risks and uncertainties that could cause actual results to differ materially from the results predicted in these forward-looking statements are described under the captions “Risk Factors” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Personalis’ Quarterly Report on Form 10-Q for the quarter ended June 30, 2025, filed with the Securities and Exchange Commission on August 5, 2025. All information provided in this release is as of the date of this press release, and any forward-looking statements contained herein are based on assumptions that we believe to be reasonable as of this date. Personalis undertakes no duty to update this information unless required by law.