NEW YORK (GenomeWeb) – Proteomics International (PILL) has completed initial validation of its proteomic test for diabetic kidney disease and is now looking for partners with which to continue vetting the test.
Named PromarkerD, the test uses panels of two to six proteins to both predict risk of developing kidney disease in diabetics and diagnose patients with diabetic kidney disease.
The Perth, Australia-based company said this week that it has completed a four-year, 576-patient study of the test. In the study, 10 percent of subjects developed diabetic kidney damage within this four year period, and PromarkerD identified 67 percent of these patients prior to onset of the disease.
PromarkerD was developed through PILL's work on Australia's Busselton Health Study, a landmark epidemiological research program launched in 1966 to study diseases common in the Australian population, and the Fremantle Diabetes Study, a longitudinal study coordinated by the University of Western Australia.
PILL began developing the test in 2009, using iTRAQ labeling and MALDI TOF/TOF mass spectrometry on an AB Sciex 4800 TOF/TOF instrument to look at a total of 180 subjects from the two studies: 60 healthy controls, 60 with mild diabetic nephropathy, and 60 with severe cases of the disease.
From this they identified roughly 150 candidate biomarkers which they then narrowed to a panel of 13 proteins using multiple-reaction monitoring mass spec on an AB Sciex 4000 QTRAP.
With these markers in hand, PILL launched the recently completed validation study. The company also received a A$1 million (US$ 780,000) grant in 2012 from Commercialisation Australia to support development of the test.
PILL is now looking for commercial partners to further develop the test as a clinical assay, Chuck Morrison, the company's head of business development, told GenomeWeb. In particular, he said, it is targeting as potential partners pharma companies with drug development efforts aimed at diabetic kidney disease.
"We've identified the proteins, we've done work developing the antibodies [to move the test to an immunoassay platform], and now we are looking for partners to bring it to the next stage for commercialization," he said.
In its current form, PromarkerD uses a panel of six proteins. However, Morrison said that the exact number of proteins to be used in the final clinical assays remains to be determined and could vary depending on the ultimate uses and markets for the test.
"We have run several different panels, and that's why we want to work with a commercial partner and start evaluating which models make the most commercial sense," he said.
In February, PILL announced an agreement with Chinese pharmaceutical firm New Summit Biopharma to develop the test for the Chinese market. Under the terms of that agreement, New Summit committed an initial $1.1 million to the development effort, which it will lead. The two companies will also collaborate to raise additional funds for the project and to seek licensing partners for the finished test.
In the US and Europe, PILL is targeting pharma companies with an interest in developing drugs for diabetic kidney disease, Morrison said, noting that one potential use of the test would be in selecting patient cohorts for clinical trials for such drugs.
The company also envisions the test as a screening tool for identifying diabetics at high risk of going on to develop kidney disease, Morrison said. In the recently completed trial, the test identified these patients with an accuracy of 67 percent. Morrison did not provide firm breakdowns of its sensitivity and specificity but said that it performed with positive predictive value of around 60 percent and negative predictive value in the high 90 percent range.
Patients identified as at-risk using the prognostic version of PromarkerD could then be tested regularly for diabetic kidney disease using the diagnostic version of the panel, Morrison said.
In addition to diabetic kidney disease, PILL has a protein biomarker research program focused on Alzheimer's disease. It also offers proteomics-based contract research services and drug discovery work.
Launched in 2001, PILL went public in April of this year, raising A$3.05 million via the issue of 15.25 million shares at A$.20 each. It had previously targeted a raise of up to A$6 million through an offering it announced in November 2014 but then delayed.