Proteomics International Laboratories Ltd (ASX: PIQ) has confirmed a new study has demonstrated that the PromarkerD test for diabetic kidney disease outperforms current standard of care tests in predicting kidney function decline in type 2 diabetes.
The research, presented at Kidney Week 2021, the annual meeting of the American Society of Nephrology (ASN), compared the PromarkerD test to current standard of care tests, the estimated glomerular filtration rate (eGFR) and urinary albumin:creatinineratio (ACR). The study updates and extends previous analysis and constitutes a core body of evidence underpinning the performance of PromarkerD for submissions to global regulators.
The results showed PromarkerD outperformed the current tests in predicting the onset of diabetic kidney disease during the four-year follow-up period. The study involved retrospective analysis of more than 850 community-based patients with type 2 diabetes from the Fremantle Diabetes Study Phase II.
In the study, PromarkerD correctly identified 84% of patients with normal kidney function who went on to experience kidney function decline in the next four years. Critically, all of these patients would have been missed by the eGFR and ACR tests which constitute the current gold standard of care under the global KDIGO (Kidney Disease Improving Clinical Outcomes) guidelines for risk classification. PromarkerD also identified 89% of patients with abnormal kidney function who declined further over the course of the study.
The PromarkerD test measures the level of three plasma biomarkers in the blood. These are combined with clinical data in a validated algorithm to provide a PromarkerD score categorised as low, moderate or high risk.
The study found patients classified by PromarkerD as high risk were 21 times more likely to develop diabetic kidney disease (DKD) within four years than those classified as low risk. Patients classified as moderate risk by PromarkerD were 8 times more likely than low-risk patients to develop the disease.
PromarkerD also had significantly higher (P <0.001) predictive performance (AUC = 0.88) compared to eGFR (0.82), ACR (0.63), and eGFR and ACR combined (0.82).
Across all KDIGO categories of diabetes and kidney disease PromarkerD exhibited an excellent “rule-out” rate (Negative Predictive Value [NPV] >96%), for categorising patients at low risk of developing DKD, and demonstrated considerably less false positives compared to standard of care testing.
Proteomics International managing director Dr Richard Lipscombe said PromarkerD testing can help improve the management of diabetes for both patients and the healthcare system.
PromarkerD gives doctors the data they need to support early introduction of preventive medications to slow the progression of DKD in high-risk patients, closer monitoring of risk factors in moderate-risk patients, and rationalised treatment options in low-risk patients,” he said