FDA Issues Emergency Authorization For Cobas SARS-CoV-2 Test
The FDA has granted Emergency Use Authorization for the cobas SARS-CoV-2 test.
The US Food and Drug Administration (FDA) has granted Emergency Use Authorization for the cobas SARS-CoV-2 test. The test, produced by Roche, is used to detect SARS-CoV-2 in oropharyngeal and nasopharyngeal swab samples.
In light of the urgent medical need for testing, it is noteworthy that the test can be run on existing automated cobas 6800 and cobas 8800 analyzer systems which are available throughout the United States.
“Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic,” Thomas Schinecker, CEO of Roche Diagnostics, said in a press release.
This is one of several diagnostics granted Emergency Use Authorization during the outbreak.
The cobas test provides results in 3 and a half hours and can be run simultaneously with other assays provided by roche. The cobas SARS-CoV-2 test is a single-well dual target assay including specific detection of SARS-CoV-2 as well as pan-sarbecovirus detection.
The diagnostic is a reverse transcription polymerase chain reaction test which detects nucleic acids from SARS-CoV-2 and gives a qualitative yes/no diagnosis answer.
The test is not FDA approved. The Emergency Use Authorization allows certified laboratories to use the unapproved test in order to meet an urgent medical need. Negative results should not be used as the sole basis for ruling out infection.
At least 132,567 cases have been confirmed globally by the World Health Organization (WHO) as of March 13. WHO now classifies the outbreak as a pandemic. There have been 4947 deaths, but at least 60,000 recoveries as well.
In the United States, there have been upwards of 1260 cases.