Personalis wins UKCA mark for cancer detection test in Great Britain

Personalis, Inc. (Nasdaq: PSNL) has received UKCA (United Kingdom Conformity Assessed) marking for its NeXT Personal Dx test, a cancer minimal residual disease (MRD) detection product, allowing its clinical use across England, Wales, and Scotland.

The UKCA marking confirms the test meets the United Kingdom's safety, health, and performance standards. The clearance allows pharmaceutical companies conducting multinational clinical trials to use the NeXT Personal Dx platform across both U.S. and U.K. sites for MRD detection.

"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. "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 detect circulating tumor DNA (ctDNA) to track cancer treatment response, identify residual cancer, and detect recurrence. The test is also intended for use by biopharma sponsors to measure early treatment response and evaluate trial endpoints.

Link Medical Solutions Ltd., based in London, England, will serve as Personalis's commercial partner for the NeXT Personal Dx test in Great Britain, supporting its commercialization and access for patients and clinicians.

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