San Diego-based ClearNote Health has achieved a significant regulatory milestone with the receipt of United Kingdom Conformity Assessed (UKCA) marking for its Avantect multi-cancer detection test and Avantect ovarian cancer test. This designation, part of the UK's independent product safety framework following its departure from the European Union, confirms compliance with UK medical device regulations and serves as a prerequisite for selling these diagnostic products in the UK market.
Novel Epigenomic Approach to Cancer Detection
The Avantect multi-cancer detection test represents a breakthrough in early cancer screening technology, designed as a simple blood test to screen for several types of cancer simultaneously in asymptomatic, generally healthy individuals. The test 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 detection methods, ClearNote Health's 5hmC-based approach measures changes in active biology, offering a highly specific signal of early cancer development while identifying the likely tissue of tumor origin. This innovative methodology captures biological changes that occur during early cancer development, potentially enabling detection before symptoms appear.
National Cancer Institute Recognition
The clinical significance of ClearNote Health's technology was validated through its selection for the National Cancer Institute's prestigious Vanguard Study. The Avantect multi-cancer detection test was one of only two assays chosen from 23 emerging multi-cancer detection technologies following a thorough evaluation process.
The Vanguard Study, funded by the National Institutes of Health, 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 comprehensive 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.
"Being selected for this critical study after a rigorous, objective technology benchmark evaluation by the NCI is a huge validation for our company, our proprietary technology platform, our employees, and the patients we serve," said Dave Mullarkey, CEO at ClearNote Health.
Targeted Ovarian Cancer Screening
The Avantect ovarian cancer test addresses a critical unmet need in women's health by focusing on earlier diagnosis of cancer in women at elevated risk. The test specifically targets women 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.
Leveraging ClearNote Health's underlying Virtuoso epigenomics platform, the test measures the presence or absence of an abnormal signal associated with ovarian cancer in cell-free DNA. Results are reported qualitatively as either "abnormal signal detected" or "abnormal signal not detected." When an abnormal signal is identified, further evaluation is recommended, including routine oncologic assessment and additional imaging measures such as transvaginal ultrasound or MRI.
Expanding Global Market Access
The UKCA marking represents the latest in a series of regulatory achievements for ClearNote Health. The company's Avantect pancreatic cancer test received the same certification in July 2025, demonstrating the company's systematic approach to international market expansion.
"By achieving United Kingdom Conformity Assessed 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," Mullarkey stated. "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."
