Summary:
ClearNote Health has received UKCA marking for its Avantect Pancreatic Cancer Test, enabling commercial availability in the UK and marking a key regulatory milestone for the company.

Takeaways:

  • Early detection focus: The Avantect test uses epigenomic and genomic analysis of blood samples to detect pancreatic cancer at its earliest stages.
  • SAFE-D study deployment: The test is already being used in the UK’s SAFE-D clinical trial involving up to 15,000 patients with recent diabetes diagnoses.
  • Regulatory advancement: UKCA approval is ClearNote’s first formal in vitro diagnostic clearance, supporting international expansion beyond lab-developed tests.

ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that it has received UK Conformity Assessed (UKCA) marking for its Avantect Pancreatic Cancer Test. The UKCA mark, established as part of the United Kingdom’s independent product safety regulatory framework following its departure from the European Union, signifies compliance with UK medical device regulations and paves the way for commercial availability in the UK market.

Avantect Pancreatic Cancer Test Is Innovative Blood Test

The Avantect Pancreatic Cancer Test is an innovative blood test designed to detect pancreatic cancer at its earliest and most treatable stages. The test analyzes epigenomic and genomic data generated by sequencing circulating, cell-free DNA collected from a simple blood draw. It is designed to be part of a diagnostic evaluation, interpreted in the context of other clinical findings for the diagnosis of this cancer type.

SAFE-D Study Used Avantect

As many as 15,000 patients in the UK recently gained access to the Avantect Pancreatic Cancer Test through the Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study. This landmark clinical trial is sponsored by the University Hospital Southampton, NHS Foundation Trust, and is being conducted by researchers at the Southampton Clinical Trials Unit at the University of Southampton. The UKCA mark paves the way for ClearNote Health and its distributors to offer the Avantect Pancreatic Cancer Test to UK patients who are not participating in the SAFE-D study.

“Achieving UKCA marking for the Avantect Pancreatic Cancer Test is a significant milestone as the first in vitro diagnostic approval for ClearNote Health,” says Dave Mullarkey, CEO at ClearNote Health. “It represents the company’s transition from laboratory-developed tests to formally regulated commercial diagnostics, reinforcing our commitment to quality, clinical rigor, and global regulatory standards. This approval lays the foundation for additional international expansion and broader patient access.”

For more information on the Avantect Pancreatic Cancer Test, please visit www.avantect.com.

Featured Image: Pakawadee Wongjinda | Dreamstime.com