The Type 2 Diabetes diagnostic research and development project is in late stage development.
This diagnostic employs antibody-based detection of a protein or proteins in urine that can indicate presence of Type 2 Diabetes. It will be a more suitable diagnostic for screening the population than the current gold standard, the oral glucose tolerance test (OGTT), as it will be non-invasive and can be sold over the counter rather than involving the collection of blood and pathology testing.
Currently 15% of 55-65 year olds have Type 2 Diabetes but approximately 50% are undiagnosed due to the reluctance of people to undergo an OGTT. This test requires, fasting, a blood sample, ingestion of a syrupy glucose slug and a further blood sample 2 hours later. A biological fluid sample would be quick to obtain and analyse for the presence of markers of Type 2 Diabetes and greatly increase rates of diagnosis. Our test will have strong competitive advantages to the current glucose level test because of its ease of sample collection and potential for home/surgery use allowing wider acceptance of screening. This will mean more Type 2 Diabetics will be identified at an earlier stage in their disease process thus enabling a better health outcome.
The Type 2 Diabetes diagnostic test will be superior to the existing test that depends on arbitrary levels of blood glucose. Our test will detect specific biomarker proteins present in urine of diabetics (and potentially prediabetes) regardless of fasting state.
The novel diagnostic test could ultimately be used in place of the OGTT or for the identification of high-risk individuals who should undergo testing for diabetes and pre-diabetes using the OGTT. Focused use of the OGTT in appropriately selected individuals would reduce costs, limit burden, and improve the yield of diagnostic testing for diabetes and pre-diabetes. |
