ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that it has received a United Kingdom Conformity Assessed (UKCA) marking for its Avantect® Multi-Cancer Detection Test and Avantect® Ovarian Cancer Test. Part of the UK's independent product safety framework following its departure from the European Union, this designation confirms compliance with UK medical device regulations and is a prerequisite for selling products in the UK. The company's Avantect Pancreatic Cancer Test received the same certification in July 2025.
The Avantect Multi-Cancer Detection Test is a simple blood test designed to screen for several types of cancer simultaneously in asymptomatic, generally healthy persons. It targets some of the deadliest cancers by analyzing both the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) and genomic features in circulating cell-free DNA. Unlike conventional methods, ClearNote Health's 5hmC-based approach measures changes in active biology, offering a highly specific signal of early cancer development and identifying the likely tissue of tumor origin.
This test was one of only two assays recently selected for the critical Vanguard Study funded by the National Cancer Institute, part of the National Institutes of Health, following a thorough evaluation of 23 emerging multi-cancer detection technologies. The Vanguard Study implemented a stringent, multi-stage selection process to evaluate multi-cancer detection assays based on sensitivity, specificity, tissue of origin prediction accuracy, and assay failure rates. Key selection criteria included early-stage detection performance for at least three cancer types. The study includes nine geographically diverse clinical trial hubs and will enroll up to 24,000 total participants to assess the implementation of multi-cancer detection testing.
The Avantect Ovarian Cancer Test was designed to aid in earlier diagnosis of cancer in women at elevated risk, particularly those with inherited genetic mutations, such as BRCA1 and BRCA2, Lynch syndrome, or a strong family history of ovarian, breast, uterine, or colorectal cancer, as well as other significant risk factors. The test uses ClearNote Health's underlying Virtuoso epigenomics platform to measure the presence or absence of an abnormal signal associated with ovarian cancer in cell-free DNA.
"By achieving UKCA markings for all three of our Avantect cancer tests, ClearNote Health is well poised to deliver on our mission of helping to eradicate the deadliest forms of cancer through early detection," said Dave Mullarkey, CEO at ClearNote Health. "These regulatory milestones are a testament to the dedication of our cross-functional team as we expand into new international markets and bring our innovative, life-saving technology to more patients worldwide."
For more information on the Avantect cancer tests, 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. Its highly sensitive, noninvasive Avantect® pancreatic and ovarian diagnostic tests may identify cancers in high-risk patient populations earlier than conventional approaches, when patients may be more likely to benefit from treatment. ClearNote Health's headquarters and CLIA-certified, CAP-accredited laboratory are located in San Diego. For more information, visit www.clearnotehealth.com or follow the company on LinkedIn.
ClearNote Health, the ClearNote Health logo, and Avantect are registered trademarks of ClearNote Health.
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