Personalis Receives Medicare Coverage for NeXT Personal® for Immunotherapy Monitoring Across Late-stage Solid Tumors

Key Terms

minimal residual disease (mrd) medical

The presence of minimal residual disease (MRD) means a very small number of cancer cells remain in the body after treatment, too few to cause symptoms or show up on routine scans but detectable with sensitive tests. For investors it matters because MRD status is a strong early indicator of whether a patient is likely to relapse and is increasingly used as a trial endpoint and regulatory signal, affecting a therapy’s market prospects and valuation much like finding glowing embers after a fire signals risk of re-ignition.

immunotherapy medical

Treatment that uses or enhances the body’s immune system to detect and fight disease, most often cancers or chronic infections; think of it as training or arming the body’s own soldiers to find and destroy targets. It matters to investors because successful immunotherapies can lead to high-value drug approvals, recurring revenue from long-term treatments, and changes in competitive dynamics, while failures or safety issues in clinical trials can materially affect company valuations.

centers for medicare & medicaid services’ (cms) regulatory

Centers for Medicare & Medicaid Services (CMS) is the U.S. federal agency that administers major government health programs and sets rules for which medical services, drugs and devices are paid for and how much providers are reimbursed. Think of CMS as both a large customer and a rulebook for the healthcare market: its coverage decisions and payment policies can materially change revenue and profitability for hospitals, insurers, drugmakers and medical-device companies, so investors watch its guidance closely.

molecular diagnostic services program (moldx) regulatory

A molecular diagnostic services program (moldx) is a clinical testing service that uses DNA/RNA-based techniques to identify diseases, infection agents, or biological markers that guide diagnosis and treatment decisions. Think of it as a high-precision detective that reads biological clues to tell doctors which therapy is likely to work. Investors care because such programs can create recurring lab revenue, strengthen product offerings, and increase the commercial or regulatory value of related therapies and devices.

minimal residual disease medical

Minimal residual disease (MRD) is the tiny number of cancer cells that remain in the body after treatment, often too few to show up on standard scans but detectable with very sensitive tests. For investors, MRD is important because it predicts the risk of relapse and can determine whether a therapy is seen as effective, influences regulatory and reimbursement decisions, and affects the size and timing of a drug’s market opportunity—like spotting the last weeds that can make a garden regrow if not removed.

whole-genome sequencing technical

Whole-genome sequencing is the process of reading an organism’s entire DNA instruction manual to capture all genetic information rather than just selected parts. For investors, it matters because having the full genetic picture can reveal new diagnostics, drug targets, or personalized treatments that drive product value, regulatory approvals, and long-term revenue potential, while improvements in speed and cost can expand market reach like making a complex map easier and cheaper to produce.

pseudoprogression medical

Pseudoprogression is a temporary increase in tumor size or new lesions on imaging that looks like disease worsening but actually reflects treatment-related inflammation or healing, especially with immune-based cancer therapies. For investors it matters because it can complicate clinical trial readouts, regulatory assessments, and short-term stock moves if apparent setbacks are later shown to be false alarms — like a bruise swelling before it starts to heal, making progress harder to judge at first.

Expanded coverage, supported by published data from the Vall d’Hebron Institute of Oncology (VHIO), enables Medicare beneficiaries receiving immunotherapy to access ultrasensitive MRD testing to monitor treatment response and predict clinical outcomes.

FREMONT, Calif.--(BUSINESS WIRE)-- Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that the Centers for Medicare & Medicaid Services’ (CMS) Molecular Diagnostic Services Program (MolDX) has expanded coverage for the company’s NeXT Personal minimal residual disease (MRD) test to include immunotherapy monitoring for patients with late-stage solid tumors.

This coverage determination is underpinned by landmark clinical evidence generated in collaboration with the Vall d’Hebron Institute of Oncology (VHIO). The recently published study demonstrated that NeXT Personal’s ultrasensitivity allows for ongoing evaluation of treatment response and the prediction of clinical outcomes in patients undergoing immunotherapy. By tracking tumor dynamics, the test can identify molecular responders and non-responders ahead of traditional radiologic imaging.

Immunotherapy has revolutionized cancer care, with several hundred thousand patients in the US receiving immunotherapy per year, yet treatment response remains variable. Identifying which patients are responding and which are not is critical for optimizing therapeutic pathways, minimizing unnecessary toxicity, and managing the high costs associated with these advanced therapies.

"Securing Medicare coverage for immunotherapy monitoring across solid tumors is a win for the patients we serve and the fight against cancer," said Chris Hall, Chief Executive Officer of Personalis. "This decision validates our strategy of moving NeXT Personal into the heart of active treatment management. For the first time, Medicare patients on immunotherapy will have an ultrasensitive MRD test to help their doctors see if a treatment is working in real-time."

NeXT Personal leverages whole-genome sequencing and advanced noise-suppression technology to achieve sensitivity down to 1 part per million (PPM). By tracking up to ~1,800 patient-specific mutations, the assay provides a high-resolution view of a patient’s unique tumor profile. In the immunotherapy setting, where inflammatory responses can often complicate the interpretation of traditional scans (a phenomenon known as pseudoprogression), NeXT Personal provides a clear, molecular signal of true disease burden.

“The VHIO data shows that immunotherapy monitoring with a highly sensitive, quantitative test like NeXT Personal can help physicians and patients understand treatment response with more precision, including situations where imaging results can be ambiguous,” said Dr. Richard Chen, M.D., M.S., President and Chief Medical Officer at Personalis. “This coverage gives physicians another tool for proactively managing immunotherapy.”

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 immunotherapy monitoring 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 ultrasensitive range, and the ability of the NeXT Personal test to evaluate treatment response and predict outcomes in patients undergoing immunotherapy; 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; Personalis’ ability to obtain Medicare coverage and reimbursement in additional indications and the timing thereof; the impact of competition and macroeconomic factors on Personalis’ business; the partnering and/or collaboration arrangements that Personalis has entered into or may enter into in the future may not be successful, or may terminate, which could adversely impact Personalis’ business or affect its ability to develop and commercialize its services and products; 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, 2025, filed with the Securities and Exchange Commission (SEC) on February 26, 2026, and Quarterly Report on Form 10-Q for the quarter ended March 31, 2026, filed with the SEC on May 7, 2026. 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.

View source version on businesswire.com: https://www.businesswire.com/news/home/20260513278817/en/

Investor Relations:
Caroline Corner
investors@personalis.com
415-202-5678

Media Contact
pr@personalis.com

Source: Personalis, Inc.