BioPorto A/S (CPH:BIOPOR) announced Wednesday a major milestone: the Danish company has submitted an application to US Food and Drug Administration for approval of its proprietary NGAL Test that assesses the risk of acute kidney injury in children under 21.
The company says the NGAL Test can detect AKI earlier and more reliably than other tests on the market. AKI is a well-known complication resulting from injury to the kidney, which is common after surgeries such as transplants.
The NGAL Test helps doctors to tailor a care plan more quickly and effectively than standard testing, reducing the risk of renal failure and/or death. The test measures NGAL levels, a biomarker which increases in response to injury, as much as 24 hours before it would otherwise be detectable. Standard testing can take up 72 hours to detect injury to the kidney.
BioPorto, based in Hellerup, Denmark, also plans to seek FDA clearance of the NGAL Test for use in adults in the second half of 2019.
Meanwhile, BioPorto said the FDA has granted the test in children as a breakthrough device, identifying that it may “provide for more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.”
Receiving this designation means that BioPorto’s application will receive priority review, reducing the expected FDA review period from 90 days to 45 days. As a result, a decision regarding the application could be received before the end of July 2019, according to a company statement.
BioPorto said its FDA application is based on a retrospective set of samples of urinary NGAL in children originally tested with the BioPorto NGAL ELISA test in 2014. The study involved 4,683 patients from 32 pediatric intensive care units across Asia, Australia, Europe and North America. Of the patients evaluated, 1,261 developed AKI and 543 patients developed severe AKI.
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