Proteomics International Laboratories Ltd (ASX: PIQ) 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.
This guidance follows the Company’s 513(g) application to the FDA made in April 2021 with the response delayed due to COVID-19 related resource limitations.
The De Novo pathway for medical device marketing in the US was added by the FDA to address novel devices of low to moderate risk, such as blood tests, that do not have a valid predicate device, i.e. there is no similar device already approved.
The FDA advised that PromarkerD was considered closest to the Acute Kidney Injury Test System, but found that the 510(k) product classification route was not available because currently there was no substantially equivalent device.
The FDA also commented that the use of multiple markers, a proprietary algorithm, and the predictive result output were each considered novel in relation to diabetic kidney disease. Consequently, the FDA advised that PromarkerD is suitable for the De Novo classification.
The company considers that the De Novo classification recognises the novel attributes of PromarkerD and will have marketing advantages upon successful approval from the FDA.
It will now prepare a full product application to the FDA proposing the PromarkerD test system as a Class IIa IVD (In Vitro Diagnostic). It is expected the Company will submit this application in Q1 CY22, with the FDA timeline for review of such applications being approximately 12 months.
The timing of the product application will enable the inclusion of Proteomics International’s new ISO 13485 contract manufacturing capability and its Janssen Stage 2 data.
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.