The blood-based test identifies early indicators of pancreatic cancer by analysing epigenomic and genomic signals. Credit: angellodeco / Shutterstock.

ClearNote Health has announced a partnership with the University of Southampton’s Clinical Trials Unit researchers to use the Avantect pancreatic cancer test in a study.

Sponsored by the University Hospital Southampton NHS Foundation Trust in the UK, the study is set to explore the link between type 2 diabetes (T2D) and pancreatic cancer, involving up to 15,000 subjects recently diagnosed with this metabolic disorder.

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The test identifies early indicators of pancreatic cancer by analysing epigenomic and genomic signals. It is particularly aimed at high-risk groups, such as those with newly diagnosed T2D, who have a significantly increased risk of developing pancreatic cancer.

The single-blinded, randomised ‘Surveillance of Pancreatic Health After Diabetes Diagnosis (SAFE-D)’ study, led by University Hospital Southampton’s consultant surgeon Zaed Hamady, will assess whether pancreatic cancer signals are present in these patients.

Hamady said: “We hope that this large study will confirm the Avantect test’s ability to detect the cancer at an early stage, so treatment can begin quickly, which should lead to much better outcomes and possibly curative treatment for patients.”

The interventional, controlled study will begin with a pilot phase in the first quarter of next year to yield significant insights into the incorporation of early pancreatic cancer detection and continuous monitoring into the care of patients with new-onset T2D.

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Designed for individuals aged at least 50 years with T2D, a family history, or a genetic predisposition to pancreatic cancer, the test profiles the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA, combined with other genomic information, to identify this malignancy type at its earliest stages.

ClearNote Health chief scientific officer Samuel Levy said: “Early cancer detection can be the difference between life and death, but clinicians are too often constrained by the limitations of existing diagnostic technologies.

“ClearNote Health is focused on transforming the patient care paradigm with a new epigenomics-based approach that allows clinicians to detect and monitor cancers at a more treatable stage so patients can live longer, healthier lives.”

In May 2023, the company reported that the Avantect test had detected pancreatic cancer in high-risk patients in a study.