Proteomics International seeks FDA approval for PromarkerD

~ Pre-submission package for diabetic kidney disease (DKD) test lodged with the US Food and Drug Administration (FDA)

~ Proteomics International expected to meet with the FDA to progress clearance within 10 weeks

~ FDA pre-submission follows CE Mark regulatory approval for PromarkerD in Europe

~Globally there are 463 million adults living with diabetes, including 31 million in the US

~ The Covid-19 pandemic has increased public awareness of the importance of diagnostic testing but caused a backlog in diagnostic services for other serious illnesses such as DKD - an issue that healthcare systems and diagnostic companies are now looking to address