Roche Secures FDA Emergency Use Authorization for Elecsys IL-6 Test 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 which measures levels of the biomarker interleukin 6 (IL-6).

The test can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation and 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. Roche’s Elecsys IL-6 is an in vitro diagnostic test for the quantitative determination of IL-6 in human serum or plasma. The assay is used in countries accepting CE-mark to aid in the management of critically ill patients, as an early indicator for acute inflammation. Under the Emergency Use Authorization in the US, the assay can be used to assist in identifying severe inflammatory response in patients with confirmed COVID‑19 illness to aid in determining the risk of intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing.

Hospitals and reference laboratories can run the test on Roche’s cobas e analyzers which are widely available around the world. These fully-automated systems 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.”

“In the current pandemic, Roche’s Elecsys IL-6 test was helpful as an early indicator for acute inflammation and in the management of critically ill patients,” said Tobias Herold, MD from the Emergency Department, University Hospital, LMU University Munich, Germany. "Elevated IL-6 values help us to identify patients with a high risk of upcoming respiratory failure.