NEW YORK ─ Proteomics International Laboratories said Thursday it has secured the CE mark for its PromarkerD Immunoassay (IA) kit, which is part of the PromarkerD test system already available in Europe for predicting the onset of kidney disease in patients with type 2 diabetes.
The Perth, Australia-based firm said PromarkerD (IA) is a high-throughput version of PromarkerD (MS), its CE marked predictive diagnostic test for diabetic kidney disease that uses mass spectrometry.
CE marking of the immunoassay kit will enable a greater number of prospective laboratories to process higher numbers of samples at a more cost-effective rate, Proteomics International said.
PromarkerD is a low-cost blood test that uses a unique protein fingerprint to detect the onset of disease up to four years before clinical symptoms appear, the company added. Its PromarkerD Hub software tool is used to calculate the risk of diabetic kidney disease.
Receipt of CE marking is anticipated to expedite execution of the licensing and sales of PromarkerD throughout Europe and lays a foundation for obtaining future regulatory approvals, including in the US, the firm said.