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.
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.
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.
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.