C2N Diagnostics announced its PrecivityAD2 blood test has received UK Conformity Assessed (UKCA) medical device certification from the Medicines and Healthcare products Regulatory Agency (MHRA). According to the company, this certification allows the test to be marketed and used clinically in the United Kingdom.
The company said the PrecivityAD2 test measures the ratio of amyloid beta 42/40 and other biomarkers in plasma to help assess the likelihood of amyloid pathology associated with Alzheimer’s disease. C2N Diagnostics claims the test offers a minimally invasive alternative to PET imaging and cerebrospinal fluid testing.
According to the company, UKCA certification builds on its previous CE mark under the EU In Vitro Diagnostic Medical Device Regulation (IVDR), expanding potential access to clinicians and patients in the UK. C2N Diagnostics said the approval supports broader adoption of its technology to aid in the evaluation of cognitive impairment.
C2N Diagnostics claims it remains focused on working with healthcare providers, researchers, and health systems to integrate the PrecivityAD2 test into clinical practice and research settings. The company said it also plans to continue advancing additional blood-based biomarker tests aimed at improving the detection and management of neurodegenerative diseases.
