ClearNote Health’s Avantect test selected for world’s largest study of pancreatic cancer detection in high-risk patient population

Dec. 18, 2024
UK NHS project will support the clinical validity and utility of early pancreatic cancer detection and surveillance testing in up to 15,000 patients with newly diagnosed type 2 diabetes.

ClearNote Health announced a new collaboration with research teams in Southampton in the United Kingdom.

Researchers at the Southampton Clinical Trials Unit, based at the University of Southampton, will use the ClearNote Health Avantect Pancreatic Cancer Test in a landmark study, sponsored by University Hospital Southampton NHS Foundation Trust, that builds on the well-established relationship between pancreatic cancer and type 2 diabetes. The prospective, multicenter study will be the largest of its kind, including up to 15,000 patient participants recently diagnosed with type 2 diabetes.

The Avantect test is a blood-based assay designed to use key epigenomic and genomic signals to detect the earliest indicators of pancreatic cancer. It is targeted for use in populations at high risk of developing this type of cancer.

One of those populations includes patients with newly diagnosed type 2 diabetes. While the exact relationship between these diseases is not yet fully understood, it is thought that in a small percentage of people newly diagnosed with type 2 diabetes, the symptoms may actually be caused by cancer affecting the function of the pancreas, which is responsible for insulin production.

The new Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study aims to determine whether pancreatic cancer signals are present in patients who were recently diagnosed with type 2 diabetes. Led by Zaed Hamady, a consultant surgeon specializing in pancreatic cancer at the University Hospital Southampton, the single-blinded, interventional, randomized, controlled study will provide valuable information about the integration of early pancreatic cancer detection and ongoing surveillance in new-onset type 2 diabetes care. It will also expand the clinical validity and utility of the Avantect test in a high-risk patient population. The study is scheduled to begin with a pilot phase in the first quarter of 2025.

The Avantect Pancreatic Cancer Test is a simple blood test 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. It 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.

ClearNote Health release