Personalis Receives Medicare Coverage for NeXT Personal® in Lung Cancer Surveillance
Lung cancer coverage, supported by data from the landmark TRACERx collaboration, follows recent approval in breast cancer, providing access to Medicare patients.
Personalis, Inc. (NASDAQ:PSNL), a leader in advanced genomics for precision oncology, today 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).
This coverage determination is grounded in clinical evidence generated through the company's collaboration with the TRACERx (TRAcking Cancer Evolution through therapy (Rx)) consortium. Data from this world-renowned longitudinal study, recently published in Cell, demonstrated NeXT Personal's ability to identify residual disease with high accuracy, validating the test's clinical performance in lung cancer.
Lung cancer remains the leading cause of cancer death in the United States, with an estimated ~230,000 new cases diagnosed annually. For patients with Stage I-III NSCLC, the risk of recurrence remains a primary clinical concern. To address this challenge, NeXT Personal is designed to detect trace amounts of circulating tumor DNA (ctDNA) that can indicate the presence of cancer, often before the cancer appears on standard of care imaging scans.
"Securing Medicare coverage for lung cancer surveillance is a big step forward on two fronts: it broadens patient access to NeXT Personal for one of the most common cancers in the US, and it is a catalyst for our continuing growth," said Chris Hall, Chief Executive Officer and President of Personalis. "For the first time, Medicare beneficiaries battling lung cancer will have access to ultrasensitive MRD testing, providing the deep insights needed to manage their care with greater confidence. Simultaneously, this coverage is a further testament to our execution. We are clinically validating our technology platform and expanding our commercial footprint in the indications that matter most."
NeXT Personal leverages whole-genome sequencing and advanced noise-suppression technology to achieve ultrasensitivity by tracking up to ~1800 mutations that represent a unique fingerprint of a patient's tumor. NeXT Personal provides clinicians with a reliable and consistent recurrence and residual disease monitoring tool in lung cancer, where shedding of ctDNA can be low and hard to detect.
"Lung cancer survivors often live with enormous uncertainty, with worry about recurrence," said Dr. Richard Chen, M.D., M.S., Chief Medical Officer and Executive Vice President of R&D at Personalis. "This coverage decision helps cancer patients and physicians get access to the NeXT Personal test, which can help them navigate the uncertainty in their cancer journey."
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. Forward-looking statements include all statements that are not historical facts, including statements relating to: the attributes, advantages, sensitivity, and clinical relevance of the NeXT Personal test, the duration of Medicare coverage in the surveillance setting, our ability to achieve continued growth and expand our commercial footprint, our ability to drive a new paradigm for cancer management, and the design of Personalis' products. 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 Personalis' ability to demonstrate attributes, advantages or clinical validity of the NeXT Personal test, including the NeXT Personal MRD assay remaining unique in its ability to detect traces of cancer in the ultrasensitive range; future clinical data differing from the clinical data previously presented or expected results; the rate of adoption and use of the NeXT Personal test; changes in health care policy, which could increase Personalis' costs, decrease Personalis' revenue, and impact sales of and reimbursement for Personalis' tests; the impact of competition and macroeconomic factors on Personalis' business; having a limited number of suppliers; and customer concentration. 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' Annual Report on Form 10-K for the year ended December 31, 2024, filed with the Securities and Exchange Commission (SEC) on February 27, 2025, as updated by Personalis' Quarterly Report on Form 10-Q for the quarter ended September 30, 2025, filed with the SEC on November 4, 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. Undue reliance should not be placed on the forward-looking statements in this press release, which are based on information available to us on the date hereof. Personalis undertakes no duty to update this information unless required by law.
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