Roche: FDA issues authorization for COVID-19 test
(CercleFinance.com) - Roche announced this morning that the Food and Drug Administration (FDA) has issued an Emergency Use Authorization for the cobas SARS-CoV-2 test.
This responds to an urgent need for patient testing during a pandemic to prevent a spread of the virus at an early stage of infection.
The CE-IVD test is also available in markets accepting the CE mark for patients who present signs and symptoms of the Covid-19 disease.
It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2,” said Thomas Schinecker, CEO of Roche Diagnostics.
After approval, Roche will have millions of tests available per month for use on the cobas 6800 and 8800 systems.
Copyright (c) 2020 CercleFinance.com. All rights reserved.
This responds to an urgent need for patient testing during a pandemic to prevent a spread of the virus at an early stage of infection.
The CE-IVD test is also available in markets accepting the CE mark for patients who present signs and symptoms of the Covid-19 disease.
It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2,” said Thomas Schinecker, CEO of Roche Diagnostics.
After approval, Roche will have millions of tests available per month for use on the cobas 6800 and 8800 systems.
Copyright (c) 2020 CercleFinance.com. All rights reserved.