Roche has announced the first commercial test for SARS-CoV-2 to meet urgent medical needs of patients and enable expedited testing in an effort to control a further spread of the virus.
Today, Roche announced that the US Food and Drug Administration (FDA) has issued an Emergency Use Authorization of the Cobas SARS-CoV-2 test. Though the test has not been FDA cleared or approved, under the Clinical Laboratory Improvement Amendments of 1988, hospitals and reference laboratories can run the test on Roche’s fully automated Cobas 6800 and Cobas 8800 Systems, which are widely available worldwide.
Thomas Schinecker, CEO of Roche Diagnostics, said, “Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic. It is important to quickly and reliably detect whether a patient is infected with SARS-CoV-2.”
To ensure efficient measures are in place to continuing testing Cobas SARS-CoV-2, Roche’s Nobel prize-winning PCR technology will ensure the full automation, increased throughput, fast turnaround time and complete track connectivity validated for molecular testing, providing users with greater flexibility to consolidate their IVD and LDT testing to a single system while increasing overall workflow efficiencies.
To find out more about innovations being made in labs around the world, including the latest technological advancements in the use of data and analytics in the lab, watch sessions from this year’s SmartLab Digital on-demand, including, Dr. Felipe Albrecht, Bioinformatics and Computer Scientist, Roche.