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Proteomics International Kidney Disease Software Tool CE Marked

NEW YORK – Proteomics International Laboratories said on Tuesday its PromarkerD Hub, a software tool for calculating the risk of kidney disease in type 2 diabetes patients, has received CE marking.

PromarkerD Hub forms part of the PromarkerD test system. Receipt of the CE mark complements the CE mark that the mass spectrometry version of the test received in November, Perth, Australia-based Proteomics International said. The firm is now preparing data for potential CE marking for the PromarkerD Immunoassay, which it expects to submit in the current quarter.

It anticipates submitting PromarkerD to the US Food and Drug Administration for regulatory clearance by mid-2020, it said. Australian regulators approved the PromarkerD Hub for export use in July.

The PromarkerD test system is a blood-based test that measures proteins for the early detection of kidney disease. In clinical studies, PromarkerD correctly predicted 86 percent of otherwise healthy diabetics who developed chronic kidney disease within four years.

Proteomics International recently completed transfer of the underlying technology for PromarkerD to Irish clinical diagnostics company Atturos, which has made the mass spec-based test available to licensing partners in Europe. Also, Patia Europe launched the test in Spain as a laboratory-based test through Atturos.