ASX-listed Proteomics International has published the findings of a major international, multi-centre clinical study involving more than 3,500 patients which provides the first-ever external support for the efficacy of its PromarkerD diagnostic test. Extraordinarily, patients identified by PromarkerD were 13.5 times more likely to develop Chronic Kidney Disease during a 4-year period.
The ability of Proteomics’ PromarkerD to effectively predict kidney disease years in advance has received its first external validation in a global study published online by the internationally recognised, peer-reviewed Journal of Clinical Medicine.
The study, which included extraordinarily complex data sets from more than 3,500 patients, concluded with a principal finding that PromarkerD could accurately predict which patients would develop Chronic Kidney Disease, or “CKD” during a four-year period.
Patients predicted by PromarkerD to be at high-risk of CKD were 13.5 times more likely than low-risk groups to develop the disease underscoring the astonishing predictive quality of the test.
The results of the study are further evidence of the efficacy of PromarkerD following studies completed in 2017 and 2019. The twin studies confirmed the PromarkerD test identified which patients would go on to develop kidney damage in the subsequent four years ‘with a sensitivity of 86 per cent and specificity of 78 per cent’.
In medical research, sensitivity refers to the percentage of correctly identified positives results while specificity is a measurement of the correctly identified proportion of negative results.
Proteomics said the joint publication with the University of Western Australia Medical School and Janssen Research and Development confirms the prognostic utility of the test for incident CKD.
Citing the study as ‘pivotal’ for the company, Proteomics International’s Managing Director and senior author of the paper, Dr Richard Lipscombe said:
“Peer-reviewed publications form an essential component of PromarkerD's adoption by Key Opinion Leaders and the wider diabetes community. The clinical data will now form an important part of the evidence in an application for FDA regulatory approval of the PromarkerD test system.”
The company said its patented PromarkerD test system uses a simple blood test to detect a unique ‘fingerprint’ of the early onset of CKD in patients with type-2 diabetes. CKD is one of the major complications arising from diabetes and if unchecked can lead to dialysis or a kidney transplant.
Whilst offsetting its R&D cash burn through the provision of specialist third-party analytical service, Proteomics looks to be vectoring in on the regulatory approval it needs to launch the commercialisation of PromarkerD into the USA where the cost of treating diabetic kidney disease is estimated at a staggering US$50 billion per annum.
Proteomics said the number of adults living with diabetes has grown four-fold since 1980 with 425 million adults now afflicted world-wide.
Having built a mountain of evidence in support of PromarkerD’s ability to predict kidney disease years in advance, Proteomics appears to be sitting on a massive, global biotechnology opportunity. Should the US FDA see fit to provide its tick of approval, that global opportunity for Proteomics could start on the US$50 billion US market and go from there.
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