Roche Secures FDA Emergency Use Authorization for Elecsys IL-6 Test to Identify Severe Inflammatory Response in COVID-19 Patients

Roche (Basel, Switzerland) has secured Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) for its new Elecsys IL-6 test to help in identifying COVID-19 patients at a high risk of severe inflammatory response.

The IL-6 immunoassay is an in vitro diagnostic test for the quantitative determination of IL-6 (interleukin-6) in human serum or plasma and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation. The FDA EUA now makes IL-6 testing accessible to patients in the US to assist in identifying severe inflammatory response in patients with confirmed COVID-19 and is also available in markets accepting the CE-mark. The test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed COVID-19 illness requires mechanical ventilation.

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 test on Roche’s fully-automated cobas e analyzers which can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending upon the analyzer.

“The FDA EUA approval of Elecsys IL-6 is another step in our commitment to deliver fast and reliable diagnostic tests to help fight the coronavirus pandemic,” said Thomas Schinecker, CEO Roche Diagnostics. “In the current situation, time is specifically critical. The test could help physicians in the quick identification of severe inflammatory response in patients infected with the SARS CoV-2 virus.”