FDA advises regulatory pathway for PromarkerD in US

Proteomics International Laboratories Ltd (Proteomics International; ASX: PIQ) is pleased to report that it has received notification from the United States Food and Drug Administration (FDA) that its PromarkerD test system for diabetic kidney disease should follow a De Novo classification pathway for regulatory approval.

Whilst the Company is pursuing FDA approval, the primary and immediate route to market for PromarkerD in the US remains the LDT (Laboratory Developed Test) path through CLIA (Clinical Laboratory Improvement Amendments) certified labs, which allows sales to commence prior to any FDA approval. Proteomics International is in advanced discussions with several parties regarding bringing PromarkerD to the US market.

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