Proteomics (ASX:PIQ) has updated investors on PromarkerD, the world’s first proteomics-derived prognostic test for the diagnosis of Diabetic Kidney Disease.
The company said it remains in ongoing discussions with a number of diagnostic and pharmaceutical companies in global markets, including the US, Europe, Japan and Latin America, for the commercialisation of PromarkerD.
It said it has been in discussion with a potential partner, which it described as a major global health care company, for a period of 11 months in relation to the partnering and licensing of PromarkerD.
"These discussions continue to progress in a positive manner," it said. "As part of this process, the potential partner requested follow-up validation studies of PromakerD to confirm its initial ground-breaking results (ASX announcement, 9 June 2015). The initial results were produced from a clinical study of 576 patients with diabetes."
The company said it is undertaking a new study on an independent cohort of 500 patients with diabetes. It also said its potential partner is in the process of providing an additional international patient study cohort, with the aim of demonstrating the robustness of PromarkerD across different geographical regions.
Proteomics said it plans to embark on its own development pathway for PromarkerD with the end-goal of developing a commercial-ready clinical pathology In vitro Diagnostic (IVD) test kit for PromarkerD.
"In undertaking its owns development pathway for PromarkerD as an IVD test kit, in conjunction with ongoing partnering and licensing discussions, PILL now has multiple, complementary commercialisation pathways for PromarkerD as a Laboratory Developed Test (LDT), standard clinical pathology IVD test and Companion Diagnostic (CDx)," it said.
In relation to the commercialisation of PromarkerD in China, the company said it continues to work with Newsummit Biopharma Co.
Managing director Dr Richard Lipscombe will present PromarkerD to key bio-analytical sector decision makers at invitation only events in Boston, San Francisco and San Diego.
The company said the focus of the presentation will be a case study on the benefit of biomarkers in the pharmaceutical development process. The events are being hosted by leading global drug development services company inVentiv Health Clinical, with Proteomics one of only two presenting companies.