ClearNote Health Receives First In Vitro Diagnostic Approval for its Avantect® Pancreatic Cancer Test

SAN DIEGO--(BUSINESS WIRE)--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.

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 pancreatic cancer.

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,” said 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.

About ClearNote Health

ClearNote Health is a privately held company dedicated to improving early detection and monitoring for some of the deadliest forms of cancer. Developed by scientists in the Stephen Quake laboratory at Stanford University, the company’s patented core Virtuoso™ epigenomics platform builds on the latest advances in artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample. The company’s highly sensitive, noninvasive Avantect^® Pancreatic and Ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most likely to benefit from treatment. ClearNote Health’s headquarters and CLIA-certified, CAP-accredited, and New York State Department of Health-permitted laboratory are located in San Diego. For more information, visit www.clearnotehealth.com or follow the company on Bluesky or LinkedIn.