FDA EUA awarded to Beckman Coulter Access IL-6 test

Oct. 2, 2020

Beckman Coulter has announced that it has received Emergency Use Authorization (EUA) for its Access Interleukin-6 (IL-6) assay from the U.S. Food and Drug Administration (FDA), according to a press release. Access IL-6 is a fully automated immunoassay designed to detect IL-6 levels in serum and plasma, which can be used to aid physicians identifying a severe inflammatory response and determining the risk of intubation with mechanical ventilation in COVID-19 patients.

IL-6 is a multifunctional cytokine that may promote inflammation in certain clinical conditions. Preliminary studies have shown that the IL-6 level is elevated in patients with severe COVID-19 and IL-6 may contribute to the severe inflammatory response, also sometimes referred to as cytokine storm.

In COVID-19 patients, pulmonary inflammation makes oxygenation more difficult and can eventually lead to acute lung injury, pneumonia or acute respiratory distress syndrome (ARDS), among other conditions. Accumulating evidence suggests that a subgroup of patients with severe COVID-19 experience increased levels of IL-6, and studies recommend identification and treatment of hyperinflammation using existing, approved therapies with proven safety profiles to address the immediate need to reduce the rising mortality. Early studies have shown that, in conjunction with other clinical findings, Access IL-6 testing results could guide patient management by identifying patients at risk for intubation with mechanical ventilation.

“An assay that helps identify patients at risk for respiratory failure and intubation in the care pathway has the potential to significantly improve COVID-19 patient care and outcomes,” said Shamiram R. Feinglass, MD, MPH, chief medical officer for Beckman Coulter. “Access IL-6 is 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, this assay provides clinicians with vital information enabling them to make decisions on how to manage these critically ill patients.”

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