FDA okays Roche’s COVID-19 diagnostic test
PMLIVE reported in its pharma news that the US Food and Drug Administration (FDA) has approved Roche’s diagnostic test for the novel coronavirus, authorising it for emergency use. The cobas SARS-CoV-2 test is intended for qualitative detection of the novel coronavirus (SARS-CoV-2), which causes the respiratory disease COVID-19. Nasopharyngeal and oropharyngeal swab samples are taken from patients who have symptoms consistent with COVID-19, with these sample then sent to hospitals and laboratories for testing on Roche’s cobas 6800/8800 systems. These systems can produce test results in three and half hours, with a total of 1,440 results provided by the cobas 6800 system and 4,128 results by the cobas 8800 system within a 24-hour period. According to the Swiss pharma, millions of tests a month will be available for use on both systems, which it said offers improved operating efficiency and flexibility.
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