Report
Dr Nathaniel Calloway

BioPorto Diagnostics - Paediatric AKI application pulled, Q4 resubmission

In July 2019 BioPorto announced that the FDA had requested additional information for The NGAL Test’s 510(k) application for paediatric acute kidney injury (AKI), although few other details were disclosed. Unfortunately, the existing clinical data set does not include the requested information, so the company will need to withdraw its current application and collect additional samples, which carries additional risk (probability of success lowered to 50% from 60%). The company forecasts that it will be able to refile an application in Q419 if sample collection goes smoothly.
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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