Summary:
ClearNote Health has received approval from the New York State Department of Health for its Avantect Pancreatic Cancer Test, allowing clinicians to order this early detection blood test for high-risk patients.

Key Takeaways:

  1. The Avantect Pancreatic Cancer Test is designed for early detection in high-risk patients using advanced epigenomic biomarkers and machine learning.
  2. Pancreatic cancer is often diagnosed at a late stage, making early detection crucial for improving survival rates.
  3. ClearNote Health’s laboratory is now approved by NYSDOH, CLIA-certified, and CAP-accredited, ensuring high-quality clinical testing.

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,” says 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.”

Avantect Pancreatic Cancer Test Is Meant for High-Risk Patients

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.

NYS Department of Health Regulates Labs that Accepts Clinical Specimens

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. 

Featured Image: Douglas Olivares | Dreamstime.com

Reference

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.