BioPorto A/S (CPH:BIOPOR) announced its first patient enrollments in its upcoming clinical study of the NGAL test, which provides an early risk assessment of acute kidney injury.
The study will examine the effectiveness of the NGAL test in critically ill children.
BioPorto is planning to submit a pediatric De Novo application to the US Food and Drug Administration (FDA) in the second half of 2020, it told shareholders.
The NGAL test, which is available for research-use-only (RUO) in the US, can detect acute kidney injury (AKI) in critically ill patients as quickly as two hours. AKI is a well-known complication that is common after surgeries such as kidney transplants and heart-bypass.
The clinical trial is taking place at Cincinnati Children’s Hospital, a major nephrology critical care center in the US. Principal investigator Dr Stuart Goldstein, director at the Center for Acute Care Nephrology at Cincinnati Children’s Hospital Medical Center, is coordinating the trial across ten leading pediatric hospitals in the US.
“The NGAL test will be an important new tool for clinicians caring for children at risk for clinically significant AKI, offering insights beyond what is available today,” Dr Goldstein said in a statement.
“We are grateful to have engaged a leading group of pediatric clinician researchers and hospitals and are eager to kick-off this important work.”
FDA submission in H2 2020
The timeline for the study was briefly delayed as a result of the coronavirus pandemic, but with hospital restrictions easing across the US, BioPorto said it remains on track to complete the trial and submit findings to the FDA in the second half of the year.
“We are excited to begin patient enrollment for this important trial in support of the company’s foremost 2020 goal, which is to submit the pediatric De Novo to the FDA,” said Christopher Bird, BioPorto’s chief medical officer.
“Since the delays caused by COVID-19, we have engaged in further collaborative discussions with FDA and are enthusiastic about our group of expert clinical collaborators. Initiating this study marks a critical step in bringing the NGAL test to the US market.”
Based in Hellerup, Denmark, BioPorto provides health-care professionals in 80 countries a range of diagnostic tests and antibodies to treat obesity and diabetes, innate immunity, allergies and infectious diseases.
Contact Angela at firstname.lastname@example.org
Follow her on Twitter @AHarmantas