CE Mark for PromarkerD Hub
CE Mark registration received for the PromarkerD Hub – a software tool used to calculate the risk of kidney disease in patients with type 2 diabetes. Registration complements the recent CE Mark for PromarkerD (MS) giving a complete package of approvals for PromarkerD in the EU and a significant foundation for future regulatory approvals in other jurisdictions, specifically US FDA registration.
The proprietary PromarkerD Hub software algorithm provides another level of IP protection on top of the Company’s granted biomarker patents. Proteomics International now to seek CE Mark registration of the PromarkerD immunoassay, which successfully completed stability testing in December. CE Mark registration anticipated to expedite execution of the licensing and sales of PromarkerD throughout Europe, where 60 million adults have diabetes and 1 in 3 currently have chronic kidney disease.