The approval allows for the clinical use of the minimal residual disease detection technology across England, Wales, and Scotland.
Personalis Inc has achieved United Kingdom Conformity Assessed (UKCA) marking for its NeXT Personal Dx test. The regulatory milestone enables the clinical use of the company’s ultrasensitive minimal residual disease detection technology across Great Britain.
The UKCA marking confirms that the test meets safety, health, and performance standards in the United Kingdom. This achievement allows pharmaceutical companies conducting multi-national clinical trials to use the platform across both US and UK sites, which may standardize detection and accelerate drug development timelines, according to Personalis.
“Achieving the UKCA mark demonstrates our ability to rapidly scale our regulatory footprint into key international markets,” says Chris Hall, CEO of Personalis, in a release. “This milestone does double duty for our business. First, it allows us to make our ultrasensitive 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.”
The test is designed to detect small traces of circulating tumor DNA. This sensitivity allows for the tracking of cancer treatment response, the detection of residual cancer, and the early detection of recurrence, according to the company. Biopharma sponsors may also use the tool to measure early treatment response and evaluate trial endpoints.
The company also notes that the regulatory approval is a step toward a mission to “transform the management of cancer through advanced, personalized diagnostic solutions.”
Personalis has partnered with Link Medical Solutions to commercialize the test in Great Britain. The partner will work to expand access to the testing for clinicians and patients across the country.
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