In vitro diagnostics company BioPorto has submitted a De Novo application to the US Food and Drug Administration (FDA) for marketing authorisation of its neutrophil gelatinase-associated lipocalin (NGAL) test.
The NGAL test is a particle-enhanced turbidimetric immunoassay that has been designed for the quantitative determination of NGAL in human urine, ethylenediaminetetraacetic acid (EDTA) plasma or heparin plasma on automated clinical chemistry analysers.
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The determination of NGAL helps to diagnose acute kidney injury (AKI), a common clinical syndrome that can lead to acute renal failure.
Additionally, the test helps physicians identify patients who are potentially at risk of AKI more quickly compared to the existing standard of care measurements.
BioPorto is seeking marketing authorisation for the NGAL test to help identify paediatric patients, aged between more than three months and less than 22 years, who are at risk of moderate to severe AKI.
The findings from the recently completed GUIDANCE trial, which exceeded the company’s prespecified targets for the NGAL test’s performance, have supported the application.
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By GlobalDataThe test has already received Breakthrough Device Designation from the US FDA and is anticipated to receive expedited review. It would be the first authorised AKI biomarker test for paediatric use commercially available in the country.
BioPorto CEO Tony Pare said: “This FDA submission is the next major milestone in the strategy BioPorto set in early 2022, focused on making our flagship product available to US-based physicians and lab directors who work with critically ill patients.
“The US market is anticipating this important and potentially lifesaving test that addresses a highly underserved patient population. I am proud of our team and their commitment to its launch.”
