Avantect Multi-Cancer and Ovarian Cancer Detection Tests Achieve UKCA Marking

The Avantect multi-cancer detection test and Avantect ovarian cancer test have received a marking from the United Kingdom Conformity Assessed (UKCA), according to ClearNote Health.1 The UKCA designation, the United Kingdom’s independent product safety framework separate from the European Union, is consistent with UK medical device regulations and is required before products can be marketed in the region.

The Avantect multi-cancer detection test is a blood-based assay designed to simultaneously screen for multiple cancers in asymptomatic, generally healthy individuals. The test targets several high-mortality malignancies by evaluating both the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) and genomic features in circulating cell-free DNA. The 5hmC-based method captures changes in active biology, and produces a highly specific signal of early cancer development, identifies the most likely tissue of origin.

Additionally, the Avantect ovarian cancer test was developed to support earlier diagnosis in women at elevated genetic or familial risk for ovarian cancer. This includes carriers of BRCA1 or BRCA2 mutations, individuals with Lynch syndrome, those with a strong family history of ovarian, breast, uterine, or colorectal cancer, and women with other significant predisposing factors. Leveraging ClearNote Health’s Virtuoso epigenomics platform, the test analyzes cell-free DNA for abnormal signals associated with ovarian cancer.

“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,” Dave Mullarkey, chief executive officer of ClearNote Health, stated in a news release. “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.”

What Was the Rationale for Authorization?

The Avantect multi-cancer detection test was one of only two assays selected for the National Cancer Institute’s (NCI) Vanguard Study, a large-scale, National Institutes of Health–funded initiative designed to evaluate the feasibility of incorporating targeted multi-cancer detection assays into randomized controlled trials (RCTs) to determine the clinical benefit of noninvasive blood-based testing for early cancer detection.

The Vanguard Study utilized a multi-stage evaluation framework to review 23 potential platforms, prioritizing sensitivity, specificity, tissue-of-origin prediction accuracy, and assay failure rates. Tests were required to demonstrate strong early-stage detection performance across at least three cancer types. The study is being conducted across 9 geographically diverse trial hubs, with plans to enroll up to 24,000 participants.2

“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,” Mullarkey noted in another news release. “The Vanguard Study will showcase the many benefits of early cancer detection, which will help drive widespread adoption of our Avantect technology and ultimately save lives.”

What is the Testing Process?

For the Avantect multi-cancer detection test, after a sample is collected and shipped to the lab for analysis, the test evaluates both the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) and genomic alterations in circulating cell-free DNA.1 Unlike traditional detection methods, the 5hmC-based approach captures changes in active biology, providing a highly specific signal of early cancer development and indicating the most likely tissue of origin.

The Avantect ovarian cancer test evaluates cell-free DNA for the presence or absence of an abnormal signal associated with ovarian cancer. Once the sample is obtained, results are reported qualitatively as either “abnormal signal detected” or “abnormal signal not detected.”3 In cases where an abnormal signal is identified, further evaluation is recommended, including routine oncologic assessment and additional imaging measures such as transvaginal ultrasound (TVUS) or MRI.

References

1. Clearnote Health receives in vitro diagnostic approval in United Kingdom for Avantect® multi-cancer detection test and Avantect® ovarian cancer test. News Release. Clearnote Health. September 25, 2025. Accessed September 25, 2025. https://www.clearnotehealth.com/press-release/clearnote-health-receives-in-vitro-diagnostic-approval-in-united-kingdom-for-avantect-multi-cancer-detection-test-and-avantect-ovarian-cancer-test/
2. Clearnote Health’s Avantect® multi-cancer detection test selected as one of two noninvasive blood-based technologies for National Cancer Institute’s Vanguard study. News Release. Clearnote Health. January 7, 2025. Accessed September 25, 2025. https://www.clearnotehealth.com/press-release/clearnote-healths-avantect-multi-cancer-detection-test-selected-for-national-cancer-institutes-vanguard-study/
3. Avantect Ovarian Cancer Test. ClearNote Health. https://www.avantect.com/avantect-ovarian-cancer-test/