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Personalis Announces Medicare Coverage for Ultrasensitive MRD Test in Breast Cancer

via Business Wire

Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced Medicare coverage of its ultrasensitive NeXT Personal® test for surveillance of cancer recurrence in breast cancer patients. This milestone marks an important step forward in cancer surveillance, offering a powerful tool for doctors and breast cancer patients.

Medicare beneficiaries with stage II and III breast cancer, including the three major subtypes HR+/HER2-, HER2+ and triple-negative breast cancer (TNBC), will now have coverage for recurrence monitoring with NeXT Personal for up to six years in the surveillance setting.

“This coverage allows us to expand access to the NeXT Personal test, supporting breast cancer patients who often live with the constant worry of cancer recurrence after treatment,” said Richard Chen, CMO and EVP of R&D at Personalis. “Our NeXT Personal test has the potential to help patients by detecting breast cancer recurrence earlier and giving them additional reassurance with negative test results.”

A study published in the Annals of Oncology this year involving patients with TNBC, HER2+, and HR+ breast cancers showed that NeXT Personal can detect very small traces of recurrent breast cancer from a blood test. In this study, NeXT Personal detected 100% of the patients who had breast cancer recurrence a median of ~15 months, and up to ~5 years, ahead of standard-of-care radiographic imaging. 100% of patients who tested negative with NeXT Personal throughout the study period remained disease-free.

“This is a major achievement for Personalis and, more importantly, it allows us to better serve the breast cancer community,” said Chris Hall, CEO of Personalis. “We have pioneered the ultrasensitive MRD testing market to address a critical unmet need in oncology. This Medicare coverage is a powerful validation of our technology and an important step forward for patients, giving them and their doctors a new tool for detecting cancer in their ongoing fight against breast cancer. Personalis remains committed to driving a new paradigm for cancer management through breakthrough personalized testing that guides care from diagnosis through the entire patient 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 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 ultra-sensitive 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 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; and having a limited number of suppliers. 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 and subsequent Quarterly Reports on Form 10-Q, including the 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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