Personalis Announces New Data from a Landmark Neoadjuvant Lung Cancer Trial Showing Superiority of Ultra-Sensitive, Tumor-Informed 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 (NeoADAURA). The findings demonstrate that Personalis’ highly sensitive molecular residual disease (MRD) test, NeXT Personal®, is a strong predictor of outcomes in patients with stage II-IIIb, EGFR-mutated non-small cell lung cancer (NSCLC) receiving neoadjuvant therapy.

The findings, which will be presented at the IASLC 2025 World Conference on Lung Cancer hosted by the International Association for the Study of Lung Cancer in Barcelona, Spain on September 7 (abstract OA02.02), demonstrate that NeXT Personal can be a more sensitive and accurate measure of MRD in the neoadjuvant setting. This supports findings in other cancer types that NeXT Personal can help doctors understand how patients are responding to neoadjuvant therapy, with the potential to guide future treatment decisions.

Key findings about NeXT Personal from the new NeoADAURA analysis:

• More sensitive: NeXT Personal demonstrated significantly higher baseline sensitivity for ctDNA detection compared to another gene-mutation based test, providing a more accurate assessment of disease burden.
• Prognostic: Baseline MRD status, as determined by NeXT Personal, was a strong prognosticator of clinical outcomes across all treatment arms.
• Associates with pathological response: Pre-surgical MRD negativity and clearance on the NeXT Personal test were shown to be associated with major pathological response (MPR).
• Useful for monitoring treatment: Osimertinib-containing regimens improved pre-surgical MRD clearance vs pbo+CT, showing the utility of ctDNA for monitoring neoadjuvant therapy response.

“The NeoADAURA results are a significant step forward for patients with early-stage lung cancer,” said Richard Chen, Chief Medical Officer and EVP of R&D at Personalis. “This study from AstraZeneca shows that ultra-sensitive ctDNA detection enabled by NeXT Personal is critical for accurately assessing neoadjuvant treatment response. It also highlights how more-sensitive detection of ctDNA can unlock crucial insights in the neoadjuvant setting. We are proud to continue our productive relationship with AstraZeneca as we work to advance the frontier of cancer care.”

The NeoADAURA trial (NCT04351555) is a global, randomized, placebo-controlled, double-blind, multi-center study of neoadjuvant osimertinib with or without chemotherapy versus placebo plus chemotherapy for patients with resectable 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.

The NeoADAURA data presentation follows Personalis’ recent submission for Medicare coverage for its NeXT Personal liquid biopsy test for use in patients with lung cancer. This marks the third indication for which the company is seeking coverage for its ultra-sensitive, whole-genome-based, tumor-informed molecular residual disease (MRD) and recurrence test.

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 ultra-comprehensive 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 NeoADAURA study or Personalis’ submissions for Medicare coverage. 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), or to Personalis’ ability to establish the medical necessity of its tests for coverage or reimbursement rates that cover its costs on the timelines expected or at all. 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.

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Source: Personalis, Inc.