BioPorto announced on 3 October 2018 that it had received feedback from the FDA on its outstanding 510(k) application for The NGAL Test for risk use with acute kidney injury (AKI). The agency said that additional data would be required to support a ‘rule-out’ claim (ie that the test can exclude the risk of AKI). The company is engaged in discussions with the agency and has revised its timeline: an FDA decision in mid-2019.
