BioPorto A/S (CPH:BIOPOR), an in-vitro diagnostics company, announced on Wednesday the submission of an application to the US Food and Drug Administration, (FDA), for regulatory clearance of The NGAL Test for risk use with acute kidney injury in the US.

Reportedly, BioPorto had filed a pre-submission in late 2016 followed by protocol development in early 2017. Patient recruitment was initiated in the second quarter of 2017 and since then more than 500 patient cases have been collected at 17 hospital sites in the US, including Yale, Cleveland Clinic, Houston Methodist Hospital and Massachusetts General Hospital.

This application together with the clinical and statistical data from this study has now been filed with the FDA.

According to the company, assuming a standard review process from the FDA, a decision regarding the application could be expected in the second half of 2018. In the event that The NGAL Test is cleared by the FDA in this timeframe, BioPorto will be in position to commence commercialising The NGAL Test by late 2018 or early 2019 in the US, which is the largest geographical market for the test.

Also, this submission of the FDA application does not alter BioPorto's financial guidance for 2018 as most recently expressed in the interim report for the first quarter of 2018, the company clarified.