#BioPorto #Exhibiting #NGAL #Biomarker #ASN #Kidney #Week
October 27, 2022
Press release
BioPorto Exhibiting NGAL Biomarker at ASN Kidney Week – Antibodies, ELISA kits, and Clinical Chemistry Assays for Early Drug Development and Clinical Research
COPENHAGEN, DENMARK and BOSTON, MA, USA, October 24, 2022, (GLOBE NEWSWIRE) — BioPorto A/S (BioPorto) (CPH:BIOPOR) today announced it will showcase its NGAL biomarker for acute kidney injury (AKI) research (clinical chemistry assay, ELISA kits, and antibodies) at booth #2734 during the world’s premiere nephrology conference, ASN Kidney Week, November 2-6, 2022, in Orlando, Florida.
BioPorto’s exhibition follows the June 2022 announcement that BioPorto achieved targeted subject enrollment for the third part of a 3-part clinical study to support a US Food and Drug Administration (FDA) De Novo submission for use of a neutrophil gelatinase-associated lipocalin (NGAL) test designed to assess the risk of moderate/severe Acute Kidney Injury (AKI) in critically ill patients (3 months to 22 years) Iin the first 24 hours of ICU admission. As previously announced, based on the quality of the clinical data and other material to support the desired claims, BioPorto anticipates submission of its De Novo application to the FDA by the fourth quarter of 2022.
The NGAL TestTM is CE marked and available for in vitro diagnostic use in the European Union; registered in several countries, and available for Research Use Only in the United States. The NGAL biomarker is one of six urinary biomarkers in the FDA’s Center for Drug Evaluation and Research’s (CDER) kidney safety composite measure. CDER encourages safety biomarkers for monitoring drug-induced renal tubular injury in early clinical drug development.
Meet with BioPorto at booth #2734 during Kidney Week 2022 to learn more.
For product information, please contact:
Commercial/product team, NGAL@bioporto.com, 844-424-6767
For investor inquiries, please contact:
Tim Eriksen, EU Investor Relations,…
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