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