NEW YORK – ClearNote Health said Wednesday that it has teamed up with researchers at the University of Southampton for a large-scale study of pancreatic cancer in patients with type 2 diabetes.
The Surveillance of pAncreatic health aFter diabEtes Diagnosis (SAFE-D) study will assess whether patients who were recently diagnosed with type 2 diabetes show evidence of pancreatic cancer using ClearNote Health's Avantect Pancreatic Cancer Test.
The multicenter, single-blinded, interventional, randomized, controlled study is sponsored by the University Hospital Southampton NHS Foundation Trust and will start with a pilot phase in the first quarter of 2025. It aims to recruit up to 15,000 participants and will generate data on the integration of early pancreatic cancer detection and ongoing surveillance in new-onset type 2 diabetes care.
Financial details of the collaboration were not disclosed.
The Avantect Pancreatic Cancer Test profiles the epigenetic biomarker 5-hydroxymethylcytosine (5hmC) in cell-free DNA, combining that information with other genomic data via the company's Virtuoso Epigenomics Platform to better detect pancreatic cancer in its earliest stages.
"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 CSO Samuel Levy said in a statement. "Today, pancreatic cancer is a devastating diagnosis, but early detection could make a world of difference for these patients."
San Diego-based ClearNote Health is not alone in seeking to combine 5hmC and genomic sequencing data. UK-based firm Biomodal recently launched its new Duet Multiomics Solution evoC kit, which enables sequencing of the four standard DNA bases, plus 5hmC and 5-methylcytosine (5mC) from the same DNA molecule and in the same workflow.
Earlier this year, ClearNote Health showed that its platform could also be applied to the prediction and monitoring of immunotherapy response for non-small cell lung cancer patients.