Australia-based Proteomics International Laboratories has reported positive results from the validation clinical study of its PromarkerD blood test to predict diabetic kidney disease.
Designed as a predictive diagnostic test, PromarkerD uses a protein fingerprint for measuring kidney disease in diabetic patients. The blood test has the capacity to predict as well as diagnose the disease.
The results from the study showed that the PromarkerD blood test can anticipate the onset of the disease better than the existing measures.
Conducted in collaboration with the University of Western Australia, the prospective clinical study examined the clinical utility of PromarkerD in 792 patients.
The three protein marker (biomarker) blood test is reported to have accurately predicted 86% of the previously kidney disease-free diabetic patients who went on to develop chronic kidney disease within four years.
University of Western Australia Medical School professor Tim Davis said: “The data supports the use of the protein biomarker panel in conjunction with estimated glomerular filtration rate (eGFR) in patients with type 2 diabetes to monitor and predict their decline in kidney function.”
When compared to the results from the original development study of the test, the predictive ability was found to be slightly low, but a 10% improvement was observed in levels of false positives.
Proteomics International managing director Dr Richard Lipscombe said: “This large clinical study validates the important role of the PromarkerD test to effectively monitor patients with diabetes.
“Although patients may appear to be adequately controlled for the complications of diabetes, current tests do not reveal early symptoms of kidney disease, which can result in the need for dialysis or kidney transplant.”