The University of Liverpool has signed a two year option agreement with the Australian diagnostics company, BARD1 Life Sciences Ltd (ASX: BD1), for a type 3c diabetes (T3cDM) blood test.
The test uses patented technology developed by researchers in the University of Liverpool's Institute of Systems, Molecular and Integrative Biology.
There are around 22.9 million new cases of new-onset diabetes diagnosed around the globe. T3cDM diabetes occurs in around 10 per cent of all new-onset diabetes cases. Currently, no test exists to identify T3cDM and it is most often misdiagnosed as type 2 diabetes (T2DM) and/or inappropriately managed. Approximately 10 in 100 people with T3cDM have underlying pancreatic cancer, with diabetes acting as an early warning sign for the presence of cancer.
Research by the University has reported that the combination of adiponectin and interleukin-1 receptor antagonist (IL-1Ra) showed a high diagnostic potential for distinction of T3cDM from T2DM (AUC = 0.90), with optimal sensitivity and specificity of 83.7% and 90.0% respectively.
Under the agreement, the University and BARD1 will evaluate two novel protein biomarkers that, in preliminary testing, have shown to accurately distinguish T3cDM from T2DM in individuals who are newly diagnosed with diabetes.
The agreement provides BARD1 with the option to licence the intellectual property for the development and commercialisation of a type 3c test on commercial terms. BARD1 will pay a non-material upfront option fee and support patent costs incurred by the University of Liverpool.
Professor of Molecular Oncology, Eithne Costello, heads up the project at the University. She is lead researcher on the UK-Early Detection Initiative (UK-EDI) which is collecting relevant samples which will allow validation of the T3cDM markers in larger sample sizes.
Professor Costello said: "In the field of pancreatic cancer, there is currently widespread interest in finding ways to detect pancreatic cancer in individuals over 50 years who are newly diagnosed with diabetes. The UK-EDI study will collect pre-diagnostic samples and data from individuals who will subsequently receive a diagnosis of pancreatic cancer. This represents a significant step forward for the field of early pancreatic cancer detection and diagnosis."
These findings have key implications for future pancreatic cancer screening because certain individuals with T3cDM are at increased risk of developing pancreatic cancer. Known risk factors for pancreatic cancer include smoking, obesity, diabetes and chronic pancreatitis (the predominate cause of T3cDM).
An accurate and reliable T3cDM test could be used to identify an at-risk population for a routine screening program for pancreatic cancer. Notably, there are no current screening tests available for pancreatic cancer and BARD1 is investigating two novel approaches for screening pancreatic cancer using its SubB2M and EXO-NET technologies, with the aim of introducing a world-first screening test for this killer disease resolving an important unmet need.
BARD1's Chief Scientific Officer Dr Peter French said: "In and of itself, a test for T3cDM could be a potential blockbuster diagnostic assay, as there would be a strong clinical case for using it to screen all individuals diagnosed with new-onset diabetes. Those individuals that test positive for type 3c diabetes could then be placed in an enhanced surveillance program and screened annually for pancreatic cancer using the Company's specific pancreatic cancer tests currently in development. Clearly this approach could provide a significant improvement in outcomes for patients with both diseases."
Researchers developing this technology have been supported by grants from Pancreatic Cancer Action (PCA), Pancreatic Cancer UK (PCUK) and North West Cancer Research (NWCR). Further validation work is being supported by Cancer Research UK (CRUK).
The negotiation of the option agreement has been managed by the University of Liverpool's IP Commercialisation Team.