Business & Finance
BioPorto to provide additional patient information to US FDA for regulatory clearance of The NGAL Test for paediatric risk assessment of AKI
19 November 2019 -

BioPorto A/S (CPH:BIOPOR), an in vitro diagnostics company, reported on Monday that it will provide additional patient information in support of its US application for regulatory clearance of The NGAL Test for paediatric risk assessment of Acute Kidney Injury (AKI).

The company said that following a recent dialogue with the US Food and Drug Administration (FDA), it decided to supplement its paediatric 510(k) application with additional data in order to fully respond to the most recent review shared by the agency.

According to the company, the study from which BioPorto drew its original dataset was published in the premier clinical journal, The New England Journal of Medicine. This data demonstrated that the NGAL biomarker can be successfully deployed to assess risk of paediatric acute kidney injury (AKI) in the critical care setting. However, the FDA disagreed with the clinical community, expressing concern over risk of clinician bias in the data.

BioPorto added that it remains committed to addressing the significant unmet medical need for better tools to help doctors evaluate and manage critically ill patients at risk of AKI. The company will take the insights gained into FDA's thinking and approach and will use this knowledge to build a follow-on dataset designed to demonstrate NGAL's utility not only to clinicians, but also to FDA.

BioPorto expects to submit a revised and supplemented application in the second quarter of 2020, with the adult application to follow.

As a result, BioPorto's financial guidance will change from revenues of approximately DKK32m to approximately DKK29m, while EBIT for 2019 will change from a loss of approximately DKK65m to a loss of approximately DKK70m.

BioPorto provides tests and antibodies to clinicians and researchers around the world. It uses its antibody and assay expertise to transform novel research tools into clinically actionable biomarkers.