BioPorto A/S (CPH:BIOPOR) announced Monday that it will provide additional patient information in support of its US application for regulatory clearance of its NGAL test for pediatric risk assessment of 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 its 510(k) application for pediatric use of the NGAL Test to detect AKI. The company said it will provide additional data in order to fully respond to the most recent review shared by the agency.
The company noted that the “valuable study” from which BioPorto drew its original dataset was published in the premier clinical journal, The New England Journal of Medicine. The data showed that the NGAL biomarker can be successfully deployed to assess risk of pediatric 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.
Although disappointed in the short-term setback, BioPorto said 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 said it will take the insights gained into FDA’s thinking and approach and will use it to build a follow-on dataset designed to demonstrate NGAL’s utility not only to clinicians but also to the FDA.
The Danish company expects to submit a revised and supplemented application in the second quarter of 2020, with the adult application to follow.
“Moving forward, BioPorto also has the opportunity to use our deeper understanding of the FDA’s requirements to improve and augment our ongoing adult studies and our planned future indications for NGAL,” said CEO Peter Mørch Eriksen in a statement.
“While we differ in the degree to which we trust clinician judgment, BioPorto has benefitted from and appreciated the candid dialog with FDA and we are looking forward to continued collaboration in our joint goal to improve and protect patient health,” he added.
As a result, BioPorto’s financial guidance will change from revenue of approximately DKK 32 million (US$4,7) to approximately DKK 29 million (US$4,2 Million). The company said the underlying earnings (EBITDA, or earnings before interest, tax, depreciation and amortization) for 2019 will change from a loss of approximately DKK 65 million (US$9.6 million) to a loss of approximately DKK 70 million (US$10,3 million).
According to the company, 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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