AKI Biomarker Test Assesses Risk of Kidney Damage in Critically Ill Patients

Because pain and other symptoms don’t usually occur, AKI can be difficult to identify, but to preserve kidney function it is essential that AKI is detected early and treated promptly. Until now, assessing risk of AKI in critically ill patients has relied on changes in serum creatinine and urine output, physiologic endpoints that are delayed, non-specific, and impacted by external factors such as nutritional status and muscle mass. Neutrophil gelatinase-associated lipocalin (NGAL) is a biomarker that rises rapidly in response to kidney injury, preceding changes in creatinine by as much as two to three days. By identifying patients at risk of AKI early, clinicians can take more appropriate action to manage fluid levels, avoid nephrotoxic agents, and potentially prevent permanent kidney damage.

The NGAL Test from BioPorto A/S (Copenhagen, Denmark) is a quantitative particle-enhanced turbidimetric immunoassay designed to run on automated chemistry analyzers. The test can serve as a tool for risk assessment of kidney damage and help physicians get ahead of the creatinine clock in their critically ill patients. The NGAL biomarker has been studied in over 16,500 patients in numerous settings including post-cardiac surgery, in critical illness, and post kidney transplantation. It has been shown to offer early clinical decision support to guide patient management.

BioPorto has submitted a De Novo application to the US Food and Drug Administration (FDA) of the NGAL Test to aid in identifying pediatric patients (≥3 months to <22 years) at risk of moderate to severe AKI. The submission is supported in part by results from the recently completed GUIDANCE trial, which exceeded the company’s pre-specified targets for test performance. The NGAL test received FDA Breakthrough Device Designation and is therefore expected to receive expedited review. If granted by the FDA, the NGAL test would be the first authorized pediatric AKI biomarker test commercially available in the US.

“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,” said Tony Pare, BioPorto’s Chief Executive Officer. “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.”

“Physicians caring for the most critically ill patients routinely rely on tools to assess risk for worsening illness and outcomes,” explained Dr. Stuart Goldstein, MD, FAAP, FNKF, FASN and Principal Investigator for the GUIDANCE clinical study establishing the clinical benefit of the NGAL test. “Previous to the NGAL test, we lacked such a tool to measure AKI, which afflicts as many as one quarter of hospitalized patients, increasing their risk of serious morbidity and mortality. 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.”

“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 2-3 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.”

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BioPorto A/S