Roche granted EUA for test to identify patients at risk of severe inflammatory response

June 5, 2020

Roche announced that the U.S. Food and Drug Administration (FDA) has granted an Emergency Use Authorization (EUA) for a test that can help identify patients with confirmed COVID-19 disease who could be at high risk of severe inflammatory response, according to a news release from Roche.

Under the FDA EUA, the test was approved to be used, in conjunction with clinical findings and the results of other laboratory testing, to help providers determine if severely ill COVID-19 patients require mechanical ventilation, Roche said.

Specifically, Roche’s Elecsys IL-6 test measures the levels of the biomarker interleukin 6 (IL-6) in blood serum samples. IL-6 is released by immune cells, once they are activated by virus, bacteria, or other immune cells. IL-6 acts like a messenger to activate other immune cells to fight the infection. Because IL-6 is released so early during a severe infection, it helps physicians to identify severely ill COVID-19 patients as early as possible.

Hospitals and reference laboratories can run the Elecsys IL-6 test on Roche’s cobas e analyzers, which can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests per hour, depending on the analyzer.

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