BioPorto submits answers to FDA over 510(k) application for NGAL Test

BioPorto A/S (CPH:BIOPOR) announced Thursday it has submitted answers to the US Food and Drug Administration regarding its 510(k) application for pediatric use of The NGAL Test to detect acute kidney injury (AKI). 

In a statement, the Danish company said that, following substantive dialog with the FDA and detailed data analysis, it has decided to supplement rather than withdraw its application.

In May 2019, BioPorto submitted its 510(k) application to the FDA for marketing clearance of The NGAL Test, but the agency responded in July with an Additional Information (AI) letter outlining questions that needed to be resolved in order to continue review of the application.

READ: BioPorto sees boost in revenue in second quarter

Initially, the company said it assessed that the questions in the AI letter would necessitate withdrawing and resubmitting its application.

However, in recent months, as BioPorto conducted an in-depth data review, obtained expert input, and had a series of productive interactions with the FDA, the company said it drew up a response to the AI letter. 

The completed response was submitted Thursday, which allows the 510(k)-clearance process to continue.

BioPorto said its decision to continue with the original 510(k) application does not alter its financial guidance for 2019, which was recently presented in the Interim Report for the second quarter of 2019.

The NGAL Test can detect AKI earlier and more reliably than other tests on the market. AKI is common following kidney transplants and heart-bypass surgery.

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Story by ProactiveInvestors