FDA Discourages EUA Application for COVID-19 Renal Test

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.