Study Validating ClearNote Health’s Avantect Pancreatic Cancer Detection Test Published in the Journal Clinical Gastroenterology and Hepatology

SAN DIEGO--(BUSINESS WIRE)-- ClearNote Health™, a cancer detection company focused on enabling people at risk for high-mortality cancers to live longer, healthier lives, today announced the publication of its analytical validation study for the Avantect™ Pancreatic Cancer Test in Clinical Gastroenterology and Hepatology. Data from the study, “Epigenomic Blood-based Early Detection of Pancreatic Cancer Employing cell-free DNA,” showed robust performance of the Avantect test in the detection of pancreatic cancer in high-risk patients, such as those recently diagnosed with Type 2 diabetes. These new data support the use of ClearNote Health’s epigenomic platform in effectively identifying cancer presence in individuals at higher risk for pancreatic cancer, thereby facilitating timely disease detection and intervention.

Early detection of pancreatic cancer has been shown to drastically improve survival rates. With pancreatic cancer projected to become the second leading cause of cancer deaths by 2030, early detection and diagnosis can offer an improved chance for successful treatment and long-term survival.^[1] The study describes the development and validation of the Avantect Pancreatic Cancer Test, a simple DNA-based blood test primarily measuring changes in 5-hydroxymethylcytosine (5hmC) signals in cell-free DNA from plasma. The case-control validation study results, based on 2,150 patient samples, demonstrated high specificity (96.9%) and early-stage (Stage I/II) sensitivity (68.3%).

“We continue to build the evidence base supporting the use of the Avantect Pancreatic Cancer Test as a way to identify patients at earlier stages of pancreatic cancer from among high-risk populations, such as those with new-onset Type 2 diabetes,” said Samuel Levy, Ph.D., chief scientific officer, ClearNote Health. “Our unique approach to early detection combines epigenomics with genomic alterations and fragmentomics as input to sophisticated machine learning algorithms. This enables us to offer clinicians an early detection test that can be used to guide patient management recommendations, and identify pancreatic cancers at early, treatable stages when longer-term patient survival is still possible.”

The Avantect Pancreatic Cancer Test is powered by ClearNote Health’s epigenomic platform, which measures active biological events that occur in tumors at the earliest stages of cancer formation. This proprietary, automated, 5hmC-based epigenomic platform enriches DNA fragments through 5hmC labeling, targeting a subset of dynamically demethylated bases. This process enables efficient and highly accurate assessments of biological events associated with gene expression and regulation that are key to the development of cancer. The Avantect early cancer detection portfolio includes the recently launched test for pancreatic cancer, available now for physician ordering in patients over 50 with Type 2 diabetes diagnosed in the past three years.

For more information on the full study results, visit: link to paper on this page.

About ClearNote Health

ClearNote Health is a cancer detection company focused on enabling people at risk for high-mortality cancers to live longer healthier lives. Utilizing a standard blood draw, the company applies its proprietary epigenomic platform, combining biology and artificial intelligence, to identify DNA-based changes in biology as cancer develops. With lead programs in non-invasive early detection of pancreatic and ovarian cancers in patients at the highest risk for these diseases, ClearNote Health identifies cancers before they progress and when patients are most likely to benefit from treatment. ClearNote Health is headquartered in San Diego, with additional presence in the San Francisco Bay area and internationally. The company’s CLIA- and CAP-accredited laboratory is located in San Diego, Calif. For more information, visit www.clearnotehealth.com or follow the company on Twitter or LinkedIn.

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