Proprietary multianalyte and multiomic assay with optimized machine learning capabilities achieve significantly higher 82% sensitivity and 97% specificity in high-risk populations

ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced the launch of its enhanced Avantect® Pancreatic Cancer Test, which delivers significantly improved detection for patients at elevated risk of this disease. With a higher overall cancer detection sensitivity of 82.6% and specificity of 97.5%, the updated test empowers clinicians to identify signals of early-stage pancreatic cancer sooner, enabling more informed and timely clinical management decisions¹.

Pancreatic cancer has a five-year survival rate of about 13%² and is currently the third leading cause of cancer-related deaths in the United States. It is projected to become the second leading cause by 2030.³ Because the disease often goes undiagnosed until it has reached an advanced stage, many patients face limited treatment options and a grim prognosis. Until now, conventional noninvasive diagnostic approaches have lacked the sensitivity and specificity required to reliably identify pancreatic cancer in its earlier stages, when patients have a better chance of survival.

The enhanced Avantect Pancreatic Cancer Test addresses this critical gap through an integrated, multianalyte and multiomic approach that relies on epigenomic 5-hydroxymethylcytosine (5hmC) patterns, genomic and genotyping information from cfDNA, and a glycan biomarker, combined with optimized machine learning algorithms. This approach has improved early-stage (I–II) sensitivity to more than 76%¹. The enhanced test performance and user-friendly patient report allow clinicians to gain earlier insight into the likelihood of pancreatic cancer, offering additional context to inform clinical judgment alongside other diagnostic tools and clinical information.

“The biggest challenge in pancreatic cancer care is detecting the disease early enough to meaningfully alter a patient’s outcome,” said Randall Brand, M.D., director of the UPMC GI Malignancy Early Detection, Diagnosis and Prevention Program and professor of medicine at the University of Pittsburgh School of Medicine. “The ability to discover critical information through a blood-based test has the potential to transform precision oncology care in pancreatic cancer through early detection.”

Designed as a simple blood-based test, the Avantect Pancreatic Cancer Test is intended for patients at elevated risk of the disease, including those with known genetic predispositions, a family history of pancreatic cancer, or those age 50 or older who have been newly diagnosed with type 2 diabetes. By evaluating multiple cancer-associated signals together, ClearNote Health’s approach provides meaningful context for care discussions. The updated test will be used for 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 being incorporated into the international Pancreatic Cancer Early Detection (PRECEDE) 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.

“People at high risk of developing pancreatic cancer deserve better than the delayed or missed diagnoses that are all too common in healthcare today. These latest enhancements to the Avantect Pancreatic Cancer Test are a direct result of our ongoing commitment to advancing earlier and more reliable cancer detection for the people who need it most,” said Dave Mullarkey, CEO at ClearNote Health. “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.”

The Avantect Pancreatic Cancer Test is currently available as a laboratory-developed test for people at high risk in the United States through ClearNote Health’s CAP/CLIA-certified laboratory, which is qualified to perform high-complexity clinical testing, and for patients outside the U.S. through ClearNote Health’s international laboratory partnership network spanning 70 countries. The test has not been cleared or approved by the U.S. Food and Drug Administration. ClearNote Health encourages patients to review their Avantect test results with their treating physician to better understand their significance and determine appropriate next steps in care.

ClearNote Health will share additional details about the improved Avantect Pancreatic Cancer Test, including the latest performance data, at the upcoming American Association for Cancer Research (AACR) and Digestive Disease Week (DDW) annual meetings.

To learn more about the Avantect Pancreatic Cancer Test, 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 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.

References

¹ Data on File

² www.cancer.org/cancer/types/pancreatic-cancer/detection-diagnosis-staging/survival-rates.html.

³ www.pancan.org/press-releases/pancreatic-cancer-deaths-continue-to-rise-five-year-survival-rate-remains-stalled-at-13-while-all-cancers-combined-reach-milestone-70/#:~:text=Pancreatic%20Cancer%20Action%20Network%20Calls,treatment%20options%2C%20and%20rese.

ClearNote Health, the ClearNote Health logo, and Avantect are registered trademarks of ClearNote Health.

The Avantect Pancreatic Cancer Test has not been cleared or approved by the U.S. Food and Drug Administration.

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"These latest enhancements to the Avantect Pancreatic Cancer Test are a direct result of our ongoing commitment to advancing earlier and more reliable cancer detection for the people who need it most,” said Dave Mullarkey, CEO at ClearNote Health.