Proteomics International Laboratories (ASX:PIQ) has updated investors on its clinical studies for PromarkerD, its test for the prediction of diabetic kidney disease.
The results have been presented at the International Conference on Functional and Interaction Proteomics: Application in Food and Health, in New Delhi, India, which is being hosted by the Proteomics Society of India.
According to the company, there are currently 415 million adults worldwide with diabetes, and approximately one-third have chronic kidney disease that can lead to dialysis or kidney transplant.
It said further analysis of the original four-year clinical study data has confirmed 10 of patients experienced a rapid decline in their kidney function when measured according to a variety of definitions of kidney function decline.
"Refinement of the PromarkerD algorithm has enabled 61-97% (84% on average) of these people to be predicted up to 4 years in advance," it said.
"PromarkerD uses a fingerprint of three proteins found in the blood in combination with simple clinical data to predict which patients will experience a decline in kidney function in the future. There is currently no available test for predicting the onset of diabetic kidney disease."
PromarkerD was developed in a $2 million clinical study in collaboration with the University of Western Australia Medical School, which followed 576 patients with diabetes for four years).
Proteomics has subsequently embarked on a follow-up study using an independent patient group with data collected between 2010 and 2016 in Western Australia. The current validation study brings the total number of patients studied to more than 1,000.
As part of the validation study a small subset of samples were provided to the Mass Spectrometry Core Facility at the University of Sydney to undertake an inter-laboratory comparison.
"Using a related but different technology platform the new data showed excellent reproducibility (between the two laboratories the assay average coefficient of variation was 11.9%, against a target of 15%)," said the company.
Proteomics International managing director Dr Richard Lipscombe said the company could not have hoped for much more from these analyses. “The improved sensitivity in our preferred definition of kidney decline and the broad applicability across other definitions indicates PromarkerD is a robust test, whilst the inter-laboratory study is an important step in proving the effectiveness of PromarkerD as a future LDT.”