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Roche Garners FDA Emergency Use Authorization for Elecsys IL-6 Test in COVID-19 Patients

NEW YORK – Roche said on Thursday that its Elecsys IL-6 test to identify severe inflammatory response in COVID-19 patients received Emergency Use Authorization from the US Food and Drug Administration. 

The test measures levels of interleukin 6, a biomarker that indicates acute inflammation, in human serum or plasma and can be used to identify COVID-19 patients at high risk of intubation with mechanical ventilation. IL-6 is released early during a severe infection, which helps physicians identify severely ill COVID-19 patients as quickly as possible, Roche said in a statement. 

The test is also available in countries accepting the CE mark to aid in the management of critically ill patients.

The Elecsys IL-6 test runs on Roche's Cobas E analyzers, which provide tests results in 18 minutes and can run up to 300 tests per hour. Under the EUA, the test can be used in conjunction with clinical findings and the results of other laboratory testing to identify patients at high risk for respiratory failure.

In May, Roche received EUA for its SARS-CoV-2 antibody test, which also runs on the Cobas E analyzer, and in March, the Basel, Switzerland-based firm received EUA for the RT-PCR Cobas SARS-CoV-2 test.