Abbott hopes to have first FDA-cleared NGAL test for kidney injury
This article was originally published in Clinica
Executive Summary
Abbott has filed a 510(k) application with the US FDA for a urine test to identify patients at risk of developing acute kidney injury (AKI). If approved, it will be the first diagnostic available in the US to measure the biomarker neutrophil gelatinase-associated lipocalin (NGAL), the company claims. The test is already CE marked for sale in Europe. Inverness Medical Innovations is also developing an NGAL test, which is available in Europe but not the US. Inverness' product analyses blood rather than urine, but both tests can diagnose AKI earlier in the disease process than the current gold standard, serum creatinine.