Siemens Healthineers’ Laboratory-Based IL-6 Assay Receives EUA

The U.S. Food and Drug Administration (FDA) has issued an Emergency Use Authorization (EUA) for Siemens Healthineers’ laboratory-based IL-6 assay¹ to measure the presence of Interleukin-6 (IL-6) in human serum or plasma.
 
IL-6 is an indicator of potential severe inflammatory response in patients with confirmed SARS-CoV-2 infection. This simple blood test may be used to assist in identifying a severe inflammatory immune response in patients confirmed to have COVID-19, to aid in determining the risk of needing intubation with mechanical ventilation, in conjunction with clinical findings and the results of other laboratory testing. Emergency use of this test is limited to authorized laboratories. Approximately five percent of COVID-19 patients develop a systemic dysregulated cytokine response known as cytokine storm.²
 
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.^3-6
 
“The Siemens Healthineers’ IL-6 assay is an important tool for the care of hospitalized COVID-19 patients. This assay expands Siemens Healthineers’ already comprehensive portfolio of tests available to aid in fighting the COVID-19 pandemic,” said Deepak Nath, PhD, president of Laboratory Diagnostics, Siemens Healthineers.
 
Siemens Healthineers’ IL-6 assay is currently available across the U.S. on the ADVIA Centaur Immunoassay Systems with a time-to-result of 18 minutes. The IL-6 assay is also available outside the U.S.⁷ with the CE mark on the ADVIA Centaur Systems, Atellica IM Analyzer and IMMULITE Systems.
 
In addition to antibody, antigen, and molecular SARS-CoV-2 tests^1,7, Siemens Healthineers offers a broad diagnostics portfolio to aid in the prognosis, treatment and follow-up of COVID-19 patients. The company’s broad and differentiated menu includes hematology, coagulation, cardiac, respiratory, inflammation and infectious disease panels. Blood gas and imaging solutions from Siemens Healthineers deliver actionable results that aid clinicians in caring for COVID-19 patients.
 
References:
¹ These tests have not been FDA cleared or approved. They have been authorized by FDA under an EUA for use by authorized laboratories. The molecular (“PCR”) test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. The serology (“antibody”) test has been authorized only for detecting the presence of antibodies against SARS-CoV-2, not for any other viruses or pathogens. The IL-6 test has been authorized only to assist in identifying severe inflammatory response, when used as an aid in determining the risk of intubation with mechanical ventilation in confirmed COVID-19 patients. These tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability may vary from country to country and is subject to varying regulatory requirements.
² Siddiqi HK, et al. J Heart Lung Transplant. 2020. https://doi.org/10.1016/j.healun.2020.03.012
³ Zhou Y, et al. National Science Review 2020. DOI: 10.1093/nor/nwaa041
⁴ Gao Y, et al. J Med Virol 2020. https://doi.org/10.1002/jmv.25770
⁵ Gong J, et al. Lancet 2020. DOI: 10.1101/2020.02.25.20025643
⁶ Del Valle, D.M., et al. Nat Med 2020. https://doi.org/10.1038/s41591-020-1051-9
⁷ Assay availability varies by country and depends on local regulatory requirements.