US FDA Approved Roche’s Cobas SARS-CoV-2 Duo for Emergency Use


Roche Announced that, the Food and Drug Administration (FDA) of the United States has issued emergency use authorization (EUA) for the cobas SARS-CoV-2 Duo for use on the fully automated cobas 6800/8800 Systems, along with expanding the covid-19 portfolio of Roche.

This has been first automated and real-time RT-PCR assay for the in vitro qualitative and quantitative detection of the SARS-CoV-2 RNA in the nasopharyngeal and nasal swab specimens.

Thomas Schinecker, chief executive officer of Roche Diagnostics said, with the SARS-CoV-2 Due test, they are now able for detecting the novel corona virus and simultaneously measuring the viral load in an individual. He also said that, the performance of the test has been suggesting that, by earlier and more accurate identification of the infected patients and the results might also open the path for the healthcare providers for more effectively organizing their therapeutic and also monitoring the inventions.

The quantitative result has been traceable to the WHO (World Health Organization) International Standard for the SARS-CoV-2 RNA and the potential benefits from the report of a standardized viral load along with the qualitative result might also be helping the clinicians in the monitoring and assessment of the infected patients across the laboratories.

READ  CDC Investigates Listeria Outbreak Linked to Deli Meats across 6 States in the US

The company also said that, Roche Diagnostic is continuing to add a range of the diagnostic solutions to their global portfolio for helping in the fight against the novel corona virus, and the test is going to be available in the United States by the second quarter of 2022.