www.fdanews.com/articles/205474-fda-discourages-eua-application-for-covid-19-renal-test
FDA Discourages EUA Application for COVID-19 Renal Test
November 23, 2021
BioPorto said the FDA has advised it not to apply for Emergency Use Authorization for its biomarker-based assay for predicting the need for renal replacement therapy in COVID-19 patients.
The test identifies neutrophil gelatinase-associated lipocalin (NGAL), which is released by kidney cells when they are under stress.
Clinical researchers at Columbia University’s Irving Medical Center conducted a study of NGAL to screen for renal failure in COVID-19 patients, with encouraging results.
The Denmark-based company started talking to the FDA about a potential EUA for the renal test in July, but said it is now following the agency’s advice to instead use a nonemergency-review pathway.