The test achieved 82.6% sensitivity and 97.5% specificity in high-risk patient populations through multianalyte approach.
ClearNote Health announced the launch of its enhanced Avantect Pancreatic Cancer Test, which delivers improved detection performance for patients at elevated risk of pancreatic cancer, according to the company. The updated blood-based test achieved 82.6% sensitivity and 97.5% specificity, with early-stage (I-II) sensitivity exceeding 76%.
The enhanced test uses a multianalyte and multiomic approach that combines epigenomic 5-hydroxymethylcytosine patterns, genomic and genotyping information from cell-free DNA, and a glycan biomarker with optimized machine learning algorithms.
“The biggest challenge in pancreatic cancer care is detecting the disease early enough to meaningfully alter a patient’s outcome,” says Randall Brand, MD, director of the UPMC GI Malignancy Early Detection, Diagnosis, and Prevention Program and professor of medicine at the University of Pittsburgh School of Medicine, in a release. “The ability to discover critical information through a blood-based test has the potential to alter precision oncology care in pancreatic cancer through early detection.”
Addressing Critical Clinical Need
Pancreatic cancer has a five-year survival rate of approximately 13% and is currently the third leading cause of cancer-related deaths in the US. The disease is projected to become the second leading cause by 2030. Because pancreatic cancer often goes undiagnosed until advanced stages, many patients face limited treatment options.
Conventional noninvasive diagnostic approaches have lacked the sensitivity and specificity required to reliably identify pancreatic cancer in earlier stages, when patients have better survival prospects.
The Avantect test is intended for patients at elevated risk, including those with known genetic predispositions, family history of pancreatic cancer, or those age 50 or older who have been newly diagnosed with type 2 diabetes.
Integration into Major Research Studies
The updated test will be used in the Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study led by the NHS in the UK—one of the world’s largest projects evaluating pancreatic cancer detection in individuals with new-onset diabetes.
The test is also being incorporated into the international Pancreatic Cancer Early Detection Consortium, a global multi-center effort focused on advancing earlier diagnosis and risk-stratified screening for people with familial or genetic risk for pancreatic cancer.
“For too long, detecting more pancreatic cancer has meant creating more false positives. Our updated test is built to deliver both high detection rates and high specificity—supporting clinicians with clearer answers and greater confidence when evaluating high-risk patients,” says Dave Mullarkey, CEO at ClearNote Health, in a release.
Availability and Regulatory Status
The Avantect Pancreatic Cancer Test is currently available as a laboratory-developed test for high-risk individuals in the US through ClearNote Health’s CAP/CLIA-certified laboratory. For patients outside the US, the test is available through the company’s international laboratory partnership network spanning 70 countries.
The test has not been cleared or approved by the FDA. ClearNote Health encourages patients to review test results with their treating physician to understand their significance and determine appropriate next steps in care.
ClearNote Health will present additional details about the improved test performance data at the upcoming American Association for Cancer Research and Digestive Disease Week annual meetings.
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