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- Proteomics International Laboratories (PIQ) reports its PromarkerD test for diabetic kidney disease has been validated in a major clinical study
- The successful trial is another positive step towards Food and Drug Administration (FDA) approval in the U.S.
- Statistically significant results indicate the test can predict diabetic kidney disease up to four years in advance — allowing for potentially critical early intervention which may reduce the need for dialysis and transplants
- The annual cost of diabetic kidney disease is estimated at US$50 billion per year in the U.S. alone
- If the test does gain FDA approval, it could provide a much-needed — and lucrative — clinical intervention in the treatment of diabetic kidney disease
- Proteomics International Laboratories is down 1.8 per cent today, with shares trading for 55 cents each
Proteomics International Laboratories (PIQ) reports its PromarkerD predictive test for diabetic kidney disease has been validated in a major clinical study.
The successful trial is another positive step towards Food and Drug Administration (FDA) approval in the U.S.
Successful trial
The study incorporated results from 3000 patients across a multi-centre clinical trial.
The data have confirmed previous findings that the PromarkerD test can correctly predict a clinically significant decline in kidney function up to four years in advance.
Results of the phase three trial confirmed patients who were predicted to be at high risk of developing kidney disease by the PromarkerD test were 13.5 times more likely than the low-risk group to develop the disease.
The statistically significant result, along with the long-term predictive capability of the test, has the potential to be a game-changer in the prognostics and treatment of diabetic kidney disease.
Of the approximately 463 million people living with diabetes worldwide, around one-third suffer diabetic kidney disease.
Next steps
Proteomics will be pursuing further studies on the pathway to FDA approval in the U.S.
The early diagnosis of potential kidney disease could be hugely significant as it may enable doctors and patients to take early action to prevent the eventual need for costly dialysis and kidney transplants.
The annual cost of diabetic kidney disease is estimated at US$50 billion per year in the U.S. alone.
Proteomics International Managing Director Dr Richard Lipscombe says the positive results give the company huge impetus for the eventual commercial rollout of the PromarkerD test.
“PromarkerD works, it’s safe, and it can be run by accredited laboratories now as a laboratory developed test (LDT),” Richard said.
“If patients know that they’re on the path to diabetic kidney disease, they can intervene sooner to treat the condition.”
Managing Director, Dr Richard Lipscombe
“This is really a green light for using this simple blood test globally. This technology has the ability to improve the lives of the 31 million Americans living with diabetes,” he added.
The next phase of the process will involve the analysis of a large clinical data set to see if patients have a better prognosis after intervention. If patients display a lower PromarkerD risk score after treatment, it would indicate the early intervention flagged by the test has been a success.
The company also plans to evaluate the performance of PromarkerD in the prediction of cardiovascular disease.
If the test does gain FDA approval, it could provide a much-needed — and lucrative — clinical intervention in the treatment of diabetic kidney disease.
Proteomics International Laboratories is down 1.8 per cent today, with shares trading for 55 cents each as at 11:40 am AEST.
