Report
Dr Nathaniel Calloway

BioPorto Diagnostics - Paediatric NGAL Test submitted with breakthrough

BioPorto announced that it had submitted an application to the FDA for the paediatric NGAL Test. The application was specifically for the risk assessment of acute kidney injury in children under the age of 21. The application was submitted with breakthrough designation, which we consider very encouraging. The designation shortens the statutory review time to 45 days (from 90) and provides that a portion of data needed be provided after marketing clearance.
Underlying
Bioporto A/S

Bioporto A/S is a Denmark-based company engaged in the development and marketing of in vitro diagnostic (IVD) assays. The Company's portfolio comprises five product categories: The Neutrophil gelatinase-associated lipocalin (NGAL) Test, which is a test for diagnosing acute kidney injury; NGAL Enzyme-linked immunosorbent assay (ELISA) kits, which supplies NGAL for the development of medicines for estimating side-effects that are harmful to kidneys; Mannan-binding Lectin (MBL) ELISA kit, which offers monoclonal MBL antibodies that are responsible for the activation of immune response; Antibodies, including monoclonal antibodies used in a range of research areas, such as microbiology, biomarkers, peptide hormones and plasma proteins; and Activated Protein C with Protein C Inhibitor Complex (APC-PCI), a biomarker applied to patients with sepsis and thrombotic and hemostatic disorders. In addition, the Company is a parent of BioPorto Diagnostics A/S.

Provider
Edison Investment Research
Edison Investment Research

Edison is an investment research and advisory company, with offices in North America, Europe, the Middle East and AsiaPac. The heart of Edison is our world renowned equity research platform and deep multi-sector expertise. At Edison Investment Research, our research is widely read by international investors, advisors and stakeholders. Edison Advisors leverages our core research platform to provide differentiated services including investor relations and strategic consulting.

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Analysts
Dr Nathaniel Calloway

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