ClearNote Health, a company dedicated to enhancing early cancer detection, has announced a new partnership with researchers at the University of Southampton’s Clinical Trials Unit in the UK. The team will utilize ClearNote’s Avantect® Pancreatic Cancer Test in a groundbreaking study sponsored by University Hospital Southampton NHS Foundation Trust. This prospective, multicenter study, which builds on the known link between pancreatic cancer and type 2 diabetes, will be the largest of its kind, involving up to 15,000 patients newly diagnosed with type 2 diabetes.
While early detection has significantly improved survival rates for many cancers, pancreatic cancer is often diagnosed at an advanced stage, leading to a low five-year survival rate of just 3%. The Avantect test is a blood-based assay designed to detect early signs of pancreatic cancer using key epigenomic and genomic signals. It targets populations at high risk, such as individuals with newly diagnosed type 2 diabetes, who are nearly eight times more likely to develop pancreatic cancer than the general population.
The exact connection between diabetes and pancreatic cancer is not fully understood, but in some cases, newly diagnosed type 2 diabetes may be a symptom of an underlying pancreatic tumor affecting insulin production. Many pancreatic cancer patients either have newly diagnosed type 2 diabetes or long-standing diabetes.
ClearNote Health’s Avantect test will be featured in the Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study, a groundbreaking study led by consultant surgeon Zaed Hamady at the University Hospital Southampton. This large-scale, randomized controlled study will explore whether pancreatic cancer signals are present in patients with newly diagnosed type 2 diabetes. The study will help integrate early pancreatic cancer detection with ongoing surveillance in diabetes care, advancing the clinical validity of the Avantect test in high-risk groups. A pilot phase is set to begin in the first quarter of 2025.
“Most pancreatic cancer cases are detected too late, leaving few treatment options. We hope this study will demonstrate the Avantect test’s ability to detect cancer early, allowing for better outcomes and potential curative treatments,” said Mr. Hamady.
Dr. Victoria Goss, Head of Early Diagnosis and Translational Research at the Southampton Clinical Trials Unit, added, “Our unit specializes in large studies for early disease detection, and we’re thrilled to collaborate with ClearNote Health to improve diagnosis and treatment for pancreatic cancer patients.”
Dr. Mikayala King, Research and Development Governance Manager at University Hospital Southampton, also expressed excitement about sponsoring the study, emphasizing its potential to benefit patients with pancreatic cancer.
The Avantect test is designed to detect pancreatic cancer in its earliest stages using a simple blood test. It profiles the epigenomic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA, providing insights into cancer development with unprecedented clarity. This approach is particularly effective for individuals over 50 who are newly diagnosed with type 2 diabetes, have a family history of pancreatic cancer, or possess a genetic predisposition.
“Early cancer detection is critical,” said Samuel Levy, PhD, Chief Scientific Officer at ClearNote Health. “Our epigenomics-based approach enables clinicians to detect cancer earlier, offering patients a better chance of treatment and improving their chances of living longer, healthier lives.”
About ClearNote Health
ClearNote Health is a privately held company focused on advancing early cancer detection. Leveraging the Virtuoso™ epigenomics platform, developed at Stanford University’s Stephen Quake laboratory, ClearNote’s noninvasive tests aim to identify cancers like pancreatic and ovarian cancers earlier than conventional methods, providing critical opportunities for treatment. The company’s laboratory is located in San Diego, and it is CLIA-certified and CAP-accredited.
