Personalis Accelerates Global Expansion with UKCA Marking for NeXT Personal®, Expanding MRD Access and Biopharma Support in Great Britain

Regulatory milestone for the NeXT Personal® Dx test enables clinical use of Personalis’ ultrasensitive MRD detection in Great Britain

FREMONT, Calif.--(BUSINESS WIRE)--Personalis, Inc. (Nasdaq: PSNL), a leader in advanced genomics for precision oncology, today announced that it has achieved UKCA (United Kingdom Conformity Assessed) marking for its NeXT Personal Dx test. This critical regulatory milestone enables the clinical use of Personalis’ ultrasensitive Minimal Residual Disease (MRD) detection technology across Great Britain, encompassing England, Wales, and Scotland.

The UKCA marking confirms that the NeXT Personal Dx test meets the United Kingdom's stringent safety, health, and performance standards. This achievement demonstrates the company's regulatory readiness and enhances Personalis’ ability to support global biopharma customers. Pharmaceutical companies running multi-national clinical trials can now leverage the clinical-grade, ultrasensitive NeXT Personal Dx platform across both US and UK sites, standardizing MRD detection and accelerating drug development timelines.

"Achieving the UKCA mark demonstrates our ability to rapidly scale our regulatory footprint into key international markets," said Chris Hall, Chief Executive Officer of Personalis. "This milestone does double duty for our business. First, it allows us to make our ultra sensitive test available to patients in Great Britain, helping oncologists detect recurrence months or even years earlier. Second, it strengthens our position as the partner of choice for global biopharma. With clinical clearance in the UK, pharmaceutical sponsors can confidently integrate NeXT Personal Dx into global trials, streamlining their pipeline development and companion diagnostic strategies."

The NeXT Personal Dx test is designed to deliver industry-leading sensitivity for detecting small traces of circulating tumor DNA (ctDNA), enabling tracking of cancer treatment response, detection of residual cancer, and early detection of recurrence. This sensitivity is also a critical tool for biopharma sponsors looking to measure early treatment response, evaluate trial endpoints with precision, and identify molecular recurrence long before it is visible on standard imaging.

This regulatory approval marks a step toward Personalis’ broader mission to transform the management of cancer through advanced, personalized diagnostic solutions.

Link Medical Solutions Ltd., London, England, will serve as Personalis’s business partner for NeXT Personal Dx in Great Britain and will support the commercialization of the test and expand access to personalized MRD testing for patients and clinicians across the country.

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 and sensitivity of the NeXT Personal test, our ability to drive a new paradigm for cancer management and support large-scale global clinical trials, the expected benefits of UKCA marking for NeXT Personal, 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 or advantages 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; our international expansion, execution of commercialization strategies through local third-party partners, and compliance with the UKCA regulatory framework; the potential that market adoption and clinical integration in Great Britain may differ from expectations due to regional healthcare dynamics; the availability of NeXT Personal to drug developers globally and its ability to help them bring new therapies to patients faster; 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; 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.