BioPorto has started 2021 firing on all cylinders as it prepares to resubmit its application to the FDA for the paediatric NGAL Test for detecting acute kidney injury (AKI) in summer 2021. This should set it up for a clearance decision in H221, after which it plans to submit the application for the adult NGAL Test. Concurrent with this, the company is initiating clinical testing of its COVID-19 dipstick. It expects this testing to be complete in early 2021 and emergency use authorisation (EUA) to be filed thereafter. We are taking this time to provide our comprehensive clinical outlook.

08 Mar 2021
BioPorto Diagnostics - Multiple upcoming readouts

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BioPorto Diagnostics - Multiple upcoming readouts
- Published:
08 Mar 2021 -
Author:
Dr Nathaniel Calloway -
Pages:
17 -
BioPorto has started 2021 firing on all cylinders as it prepares to resubmit its application to the FDA for the paediatric NGAL Test for detecting acute kidney injury (AKI) in summer 2021. This should set it up for a clearance decision in H221, after which it plans to submit the application for the adult NGAL Test. Concurrent with this, the company is initiating clinical testing of its COVID-19 dipstick. It expects this testing to be complete in early 2021 and emergency use authorisation (EUA) to be filed thereafter. We are taking this time to provide our comprehensive clinical outlook.