ClearNote Health鈥檚 Avantect Pancreatic Cancer Test has secured the UK Conformity Assessed (UKCA) marking, signifying compliance with medical device regulations in the UK.
This approval marks a step towards the commercial availability of the test in the country.
This blood test aims to identify pancreatic cancer early and at the stages when it is most treatable. It is intended to be used as part of a diagnostic evaluation, in conjunction with other clinical findings, to diagnose this cancer.
It is claimed to analyse epigenomic and genomic data from circulating, cell-free DNA obtained from a simple blood draw.
According to the company, the epigenomic changes are found in this cancer鈥檚 earliest stages, and chemical modification of DNA, 5-hydroxymethylcytosine (5hmC), could be utilised as a targeted biomarker to detect these changes.
By combining 5hmC profiling and whole-genome sequencing in one assay, the Avantect test offers a comprehensive insight into cancer biology.
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By GlobalDataValidated in high-risk patients, including those over 50 years old with newly diagnosed type 2 diabetes (T2D) and individuals with a genetic predisposition or family history of pancreatic cancer, the Avantect test has demonstrated an overall sensitivity and specificity of 66.7% and 96.9%, respectively.
As part of the SAFE-D study, approximately 15,000 UK subjects recently accessed the test.
This trial, sponsored by the University Hospital Southampton NHS Foundation Trust, is being carried out by researchers at the Southampton Clinical Trials Unit at the University of Southampton.
Last month, the company began enrolling subjects in the SAFE-D study to improve early detection among individuals newly diagnosed with T2D.
With the UKCA marking, the company and its distributors can now provide the Avantect test to the country鈥檚 patients outside the SAFE-D study.
ClearNote Health CEO Dave Mullarkey said: 鈥淎chieving UKCA marking for the Avantect Pancreatic Cancer Test is a significant milestone as the first in vitro diagnostic approval for ClearNote Health.
鈥淚t represents the company鈥檚 transition from laboratory-developed tests to formally regulated commercial diagnostics, reinforcing our commitment to quality, clinical rigour, and global regulatory standards. This approval lays the foundation for additional international expansion and broader patient access.鈥�
