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Beckman Coulter Gets FDA Emergency Use Authorization for COVID-19 Inflammatory Response Immunoassay

NEW YORK ─ Beckman Coulter said on Thursday that it has received Emergency Use Authorization from the US Food and Drug Administration for its Access Interleukin-6 (IL-6) immunoassay.

The Brea, California-based firm, part of Danaher, said the FDA authorized the fully automated assay for the detection of IL-6 levels in serum and plasma to help physicians identify a severe inflammatory response and determine 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. IL-6 levels are elevated in patients with severe COVID-19 and may contribute to a severe inflammatory response, sometimes called a cytokine storm, Beckman Coulter said, citing a University of Oxford preliminary study.

"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," Shamiram Feinglass, chief medical officer of Beckman Coulter, said in a statement. "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."