FDA issues EUA for Siemens Healthineers IL-6 test

Jan. 11, 2021

Siemens Healthineers announced that the U.S. Food and Drug Administration (FDA) has issued an emergency use authorization (EUA) for the company’s laboratory-based IL-6 assay to measure the presence of Interleukin-6 (IL-6) in human serum or plasma, according to a press release.

IL-6 is an indicator of potential severe inflammatory response in patients with confirmed SARS-CoV-2 infection. Approximately five percent of COVID-19 patients develop a systemic dysregulated cytokine response known as cytokine storm, Siemens Healthineers said.

Siemens Healthineers said its IL-6 assay could help providers assess a patient’s risk of needing intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing.

IL-6 is a type of cytokine (intercellular messenger molecule) that plays a central role in the immune response to infection and can evoke many different actions when it is released. It is substantially elevated in patients presenting with cytokine storm. Cytokine release is a normal part of the body’s immune response when fighting off a virus. However, a severe immune response can cause overproduction of cytokines leading to potential wide-scale cellular and organ damage, and ultimately death. IL-6 levels were found to be higher in COVID-19 patients with severe disease.

Siemens Healthineers’ IL-6 assay is currently available across the United States on the ADVIA Centaur Immunoassay Systems, with a time-to-result of 18 minutes. The IL-6 assay is also available outside the United States with the CE mark on the ADVIA Centaur Systems, Atellica IM Analyzer and IMMULITE Systems.

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