Physicians in New York can now order the highly sensitive blood test designed to detect pancreatic cancer far earlier than conventional approaches
SAN DIEGO — Feb. 18, 2025 — ClearNote Health, a company focused on improving early detection for some of the deadliest cancers, today announced that the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) has approved its Avantect® Pancreatic Cancer Test. With this approval, clinicians in New York State can now order this highly sensitive blood test, which is designed to detect the biological signals of pancreatic cancer in its earliest stages for patients with known risk factors.
“New York State is well known for its rigorous, patient-focused quality standards for laboratory-developed tests. This approval is another critical milestone for ClearNote Health, further validating our ongoing commitment to excellence in our tests and in our clinical laboratory services,” said Dave Mullarkey, CEO at ClearNote Health. “We are quickly transforming the patient care paradigm with a proprietary, epigenomics-based approach that allows clinicians to detect pancreatic cancer at a more treatable stage so patients can enjoy longer, healthier lives.”
While early detection has vastly improved survival rates for other types of cancer, pancreatic cancer is often diagnosed at an advanced metastatic stage when patients have a five-year survival rate as low as 3%.1 The Avantect Pancreatic Cancer Test is for patients at high risk of pancreatic cancer, including those newly diagnosed with type 2 diabetes who are at least 50 years old, as well as those with a family history and/or a genetic predisposition. The test was designed to detect pancreatic cancer in its earliest stages by profiling the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA and combining that data with other genomic information. Unlike conventional methods, ClearNote’s approach leverages the latest advances in machine learning and bioinformatics to provide a deeper understanding of the underpinnings of cancer development with unprecedented clarity to inform the next steps in a patient care pathway. For more information about the Avantect Pancreatic Cancer Test, please visit www.avantect.com.
The NYSDOH CLEP regulates and oversees laboratories that accept clinical specimens originating in New York State. It seeks to ensure the accuracy and reliability of test results in clinical laboratories located in or accepting specimens from New York State. The ClearNote Health Laboratory now has its NYSDOH permit, as well as its CLIA certification and CAP accreditation.
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. The company’s highly sensitive, noninvasive Avantect® Pancreatic and Ovarian diagnostic tests are designed to identify cancers in high-risk patient populations far earlier than conventional approaches, when patients are most 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 X or LinkedIn.
ClearNote Health, the ClearNote Health logo, Avantect, and Virtuoso are registered trademarks of ClearNote Health.
References
1. Rawla P, Sunkara T, Gaduputi V. Epidemiology of Pancreatic Cancer: Global Trends, Etiology and Risk Factors. World J Oncol. 2019 Feb;10(1):10-27. doi: 10.14740/wjon1166.