ClearNote Health’s Avantect® Pancreatic Cancer Test Approved in New York
ClearNote Health has received approval from the New York State Department of Health’s Clinical Laboratory Evaluation Program (CLEP) for its Avantect® Pancreatic Cancer Test. This approval allows New York clinicians to order the advanced blood test, which detects early biological signals of pancreatic cancer in patients with known risk factors. ClearNote Health focuses on improving early detection for high-risk, deadly cancers.
ClearNote Health has received approval from the New York State Department of Health (NYSDOH) Clinical Laboratory Evaluation Program (CLEP) for its Avantect® Pancreatic Cancer Test. This milestone allows clinicians in New York to order the advanced blood test, which is designed to detect early biological signals of pancreatic cancer in high-risk patients.
“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 of 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.”
Addressing the Challenge of Pancreatic Cancer Detection
Pancreatic cancer remains one of the deadliest cancers due to its late-stage diagnosis. While early detection has significantly improved outcomes for other cancers, pancreatic cancer is often diagnosed at an advanced metastatic stage, where the five-year survival rate is as low as 3%. The Avantect® Pancreatic Cancer Test aims to change that by enabling early detection in patients with known risk factors.
The test is designed for individuals at high risk of pancreatic cancer, including:
- Patients aged 50 and older who have recently been diagnosed with type 2 diabetes
- Those with a family history of pancreatic cancer
- Individuals with a genetic predisposition to the disease
Innovative Technology Behind the Avantect® Test
ClearNote Health’s Avantect® Pancreatic Cancer Test uses a cutting-edge approach to detect cancer at its earliest stages. The test profiles the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA and integrates this data with other genomic information. This combination provides a comprehensive view of cancer biology.
Unlike traditional diagnostic methods, the Avantect® test leverages the latest advancements in machine learning and bioinformatics. This approach enhances the test’s sensitivity and accuracy, allowing clinicians to detect subtle biological changes associated with cancer development. By providing deeper insights, the test helps guide the next steps in a patient’s care pathway.
Regulatory Approval and Laboratory Accreditation
The NYSDOH CLEP oversees and regulates clinical laboratories that accept specimens originating in New York State. The program ensures the accuracy and reliability of test results through stringent evaluation processes. With this approval, the ClearNote Health Laboratory holds a NYSDOH permit, in addition to its CLIA certification and CAP accreditation. These accreditations affirm the laboratory’s commitment to maintaining the highest standards of quality and patient care.
About ClearNote Health
ClearNote Health is a privately held company focused on improving early detection and monitoring for some of the deadliest cancers. The company’s proprietary Virtuoso® epigenomics platform was developed by scientists in the Stephen Quake laboratory at Stanford University. This platform integrates cutting-edge artificial intelligence and bioinformatics to measure active biological differences between cancer and healthy cells in a blood sample.
ClearNote Health offers noninvasive and highly sensitive diagnostic tests, including the Avantect® Pancreatic and Ovarian tests. These tests are designed to detect cancers in high-risk patient populations far earlier than conventional methods, improving the chances of successful treatment.
The company is headquartered in San Diego, where its CLIA-certified and CAP-accredited laboratory is located. With a mission to transform cancer detection, ClearNote Health continues to push the boundaries of innovation to provide life-saving diagnostics.
