BioPorto A/S (BioPorto) has decided to reapply for approval of the Company’s kidney injury test, The NGAL Test™, with the Food and Drug Administration (FDA) in USA. The decision follows a positive dialogue with FDA on factors involved in the decision to decline the company’s previous application for approval, see company announcement no. 13 of May 28, 2016.
FDA approval is important for large-scale commercialization of The NGAL Test™ in the United States. FDA declined the previous application on grounds that it did not present adequate clinical and analytical data to support approval of the device, especially in mild cases of acute kidney injury. The Company expects to base the reapplication on new data to be collected as soon as possible. read more