Instead of detecting the virus, this device can help determine who might be at risk for intubation and mechanical ventilation.
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Roche received a new Emergency Use Authorization from the U.S. Food and Drug Administration (FDA) for another COVID-19 diagnostics device. Instead of detecting the virus, this device can help determine who might be at risk for intubation and mechanical ventilation.
This morning Roche announced it received EUA from the FDA for the Elecsys IL-6 test, which measures levels of IL-6 (interleukin-6), a protein that triggers the body’s immune and inflammatory response to fight infections. 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. High levels of IL-6 can cause the immune system to begin attacking itself, unleashing a cytokine storm, which has been linked to the deaths of a number of COVID-19 patients. The IL-6 inhibitors were first used in China to calm IL-6 overreaction due to COVID-19. Data from a single-arm study of Actemra in China suggested that the interleukin-6 pathway may play an important role in the overactive inflammatory response in the lungs of patients with COVID-19.
Tobias Herold, a physician from the Emergency Department of University Hospital at LMU University Munich, said Roche’s Elecsys IL-6 test was helpful as an early indicator for acute inflammation and in the management of critically ill patients.
Roche, as well as other companies, are investigating the use of IL-6 inhibitors in these patients. The new Elecsys IL-6 test could inform physicians which patients are in need of IL-6 inhibitors, such as Roche’s Actemra, which is being investigated in multiple Phase III studies for this indication. Regeneron and Sanofi are also assessing the efficacy of their IL-6 inhibitor, Kevzara, in these patients.
The Roche Elecsys IL-6 test can be run on the company’s existing diagnostics platforms, the cobas e analyzer. These fully-automated systems can provide test results in approximately 18 minutes, with a test throughput of up to 300 tests/hour, depending on the system being used to run the test.
Thomas Schinecker, chief executive officer of Roche Diagnostics, called the EUA approval of Elecsys IL-6 another step in the company’s commitment to deliver fast and reliable diagnostics tests to battle the COVID-19 pandemic that has infected more than 6.5 million people across the globe, including 1.8 million in the United States.
“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,” Schinecker said in a statement.
Since the beginning of the COVID-19 pandemic, Roche has won EUA for several diagnostics devices, including its cobas SARS-CoV-2 Test, which looks for the presence of the virus in the body. That assay won approval in March. In May, the FDA granted EUA for Roche’s Elecsys Anti-SARS-CoV-2 antibody test that will help determine whether or not people have been infected by the novel coronavirus that has swept across the globe and developed antibodies to the disease.
