The University of Liverpool has worked with the Australian diagnostics company BARD1 Life Sciences Ltd. signed a two-year option agreement for a blood test for type 3c diabetes (T3cDM). The test uses a patented technology developed by researchers at the Institute of Systems, Molecular and Integrative Biology at the University of Liverpool.
Around 22.9 million new cases of emerging diabetes are diagnosed worldwide. T3cDM diabetes occurs in approximately 10 percent of all new cases of diabetes. There is currently no test to identify T3cDM, and it is most commonly misdiagnosed and / or improperly treated as type 2 diabetes (T2DM). About 10 in 100 people with T3cDM have underlying pancreatic cancer, with diabetes acting as an early warning sign of the presence of cancer.
Research by the university has shown that the combination of adiponectin and interleukin-1 receptor antagonist (IL-1Ra) has a high diagnostic potential for differentiating 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 new protein biomarkers that have shown in preliminary tests that they can accurately differentiate T3cDM from T2DM in people with newly diagnosed diabetes.
The agreement gives BARD1 the option to license the intellectual property to develop and commercialize a Type 3c test on commercial terms. BARD1 pays a non-essential option fee upfront and bears the patent costs incurred by the University of Liverpool.
Professor of Molecular Oncology, Eithne Costello, heads the project at the university. She is a senior researcher at the UK-Early Detection Initiative (UK-EDI), which collects relevant samples that enable validation of T3cDM markers in larger sample sizes.
There is currently widespread interest in the pancreatic cancer field in finding ways to detect pancreatic cancer in people over the age of 50 who have been newly diagnosed with diabetes. The UK-EDI study will collect predictive samples and data from people who are later diagnosed with pancreatic cancer. This is a significant step forward in the field of early detection and diagnosis of pancreatic cancer. “
Eithne Costello, Professor of Molecular Oncology, University of Liverpool
These results have important implications for future pancreatic cancer screening because certain people with T3cDM are at increased risk of developing pancreatic cancer. Known risk factors for pancreatic cancer are smoking, obesity, diabetes, and chronic pancreatitis (the predominant cause of T3cDM).
An accurate and reliable T3cDM test could be used to identify a population at risk for a routine pancreatic cancer screening program. In particular, screening tests for pancreatic cancer are currently unavailable and BARD1 is exploring two new approaches to pancreatic cancer screening with its SubB2M and EXO-NET technologies with the aim of introducing a world’s first screening test for this deadly disease, which is a major one unmet need.
Dr. Peter French, Chief Scientific Officer of BARD1, said, “A test for T3cDM in itself could be a potential blockbuster diagnostic assay as there are strong clinical grounds for using it to screen anyone diagnosed with newly developed diabetes has been.
Those who test positive for type 3c diabetes could then be placed on an expanded surveillance program and screened annually for pancreatic cancer using the company’s specific pancreatic cancer tests that are currently under development. Clearly, this approach could significantly improve 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 will be supported by Cancer Research UK (CRUK).
