The development of a companion diagnostic (CDx) test with the validation of several of its protein biomarkers is an important milestone completed by Protcomics International.
The research team authenticated the panel of biomarkers after taking 508 highly curated disease and control samples. Seven biomarkers were validated at high stringency using the company's proprietary mass spectrometry approach.
The mass spectrometry data was then cross-validated using immunoassays in collaboration with the KTH Royal Institute of Technology, Sweden, and Merck Millipore. A further five biomarkers were validated at high stringency and these are available for out-licensing. The validation was supported by a grant from Commercialisation Australia.
Proteomics International managing director Richard Lipscombe said there was excellent correlation between the new mass spectrometry platform and the traditional gold standard test, essential because antibody assays are more readily accepted by the FDA. "By doing it as a diagnostic and showing that the whole approach works, we set the foundations to create tests for other medical conditions," Dr Lipscombe said.
The next stage of development is to create a test that can determine whether patients will get diabetic kidney disease before they develop the condition. "The Holy Grail is to predict who's going to get sick and who isn't and that's something that will come out of our study later in 2014." Dr Lipscombe said. "But in the short term we want a diagnostic test that is going to provide doctors with a more accurate, robust test."
The International Diabetes Foundation estimates that there are 382 million people living with diabetes and expect the number to rise significantly. Based on current statistics 10 to 15 per cent of all people with diabetes will die from kidney disease.