BioPorto (NASDAQ COPENHAG:BIOPOR) A/S announced it has submitted a De Novo application to the US Food and Drug Administration (FDA) of a neutrophil gelatinase-associated lipocalin (NGAL) test to help identify pediatric patients at risk of moderate to severe acute kidney injury (AKI).
Results from the in vitro diagnostics company’s recently completed GUIDANCE trial, which exceeded the company’s prespecified targets for test performance, supported the application, according to a statement from BioPorto (NASDAQ COPENHAG:BIOPOR).
The NGAL test received FDA Breakthrough Device Designation and is expected to receive expedited review, added the company, making it the first authorized paediatric AKI biomarker test commercially available in the US.
READ: BioPorto maintains guidance for 2022, posts US$2.9 million revenue for first nine months of year
BioPorto told shareholders that the De Novo pathway creates a new classification for medical devices that do not have a predicate device for comparison.
Prior to the NGAL test, physicians lacked the proper tool to measure AKI, which afflicts as many as one quarter of hospitalized patients and increases the risk of serious morbidity and mortality, explained Dr. Stuart Goldstein, principal investigator for the GUIDANCE clinical study.
“Physicians caring for the most critically ill patients routinely rely on tools to assess risk for worsening illness and outcomes…The data from GUIDANCE clearly suggests that the NGAL test provides highly specific, near real-time detection of AKI that can be integrated with clinical acumen to attend to those patients truly at risk for the devastating consequences of AKI.”
Meanwhile, assessing the risk of AKI in critically ill patients currently relies on changes in serum creatinine and urine output, but both are delayed, non-specific, and impacted by other factors such as nutritional status and muscle mass, said Dr. Christopher Bird, BioPorto’s chief medical officer.
“With data from 16 hospitals across the US, GUIDANCE corroborated results from many peer-reviewed publications that show NGAL rises within hours of kidney injury, as much as two to three days sooner than serum creatinine. With earlier detection of patients at risk of AKI, clinicians can act more quickly to manage fluid levels, medications, and nephrotoxic agents, and potentially prevent permanent kidney damage.”
US market waiting for lifesaving test
BioPorto CEO Tony Pare called the FDA submission the next major milestone in BioPorto’s strategy, which is focused on making its 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,” Pare said.
BioPorto said it plans to hire personnel and continue to prepare manufacturing and quality systems, while working to make the test available for the adult populations.
Contact Angela at angela@proactiveinvestors.com
Follow her on Twitter @AHarmantas