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FDA Emergency Use Authorization Awarded to the Beckman Coulter Access IL-6 Test

FDA Emergency Use Authorization Awarded to the Beckman Coulter Access IL-6 Test

The Access Interleukin-6 (IL-6) assay is designed to assist physicians in the identification of severe inflammatory response in COVID-19 patients


October5th,2020
Beckman Coulter Diagnostics

BREA, CA — October 1, 2020 — Beckman Coulter today (Oct. 1) announced that it has received Emergency Use Authorization (EUA) for its Access Interleukin-6 (IL-6) assay from the US Food & Drug Administration (FDA). 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 studies1 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.

“Our goal is to keep patients off the ventilator as that’s the best way to help COVID-19 patients. IL-6 can help us treat the patient before they need a ventilator. The side effect of this is that we are able to reduce the number of patients on ventilators to preserve capacity if needed in a hospital,” said Joshua Hayden, PhD, DABCC, chief of chemistry, Norton Healthcare. “Any time you can have more objective measures, such as testing with IL-6 to predict which patients are going to get worse, it is helpful. I highly encourage places that have to make rationing decisions to use markers such as IL-6 to assist them.”

Mao Eniang, professor and head of emergency medicine, Ruijin Hospital; Medical School of Shanghai Jiao Tong University said, “We have learned that monitoring IL-6 levels in COVID-19 patients has become an extremely important factor in the management of these individuals, in conjunction with clinical findings and the results of other laboratory testing. Clinical cases and data suggest that cytokine storms are accompanied by high expression of IL-6 protein. We have also seen that cytokine storms, characterized by elevated IL-6 levels, may be a key factor in the deterioration of patients with severe COVID-192,3. While cytokine storms can be the result of many types of bacterial or viral infections, burns, surgical wounds, and other diseases, they develop differently depending upon the clinical scenario.”

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 patients4,5 with severe COVID-19 experience increased levels of IL-6, and studies recommend6,7,8 identification and treatment of hyperinflammation using existing, approved therapies with proven safety profiles to address the immediate need to reduce the rising mortality.9 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.”

To learn more about the Access IL-6 assay, or for the latest information on Beckman Coulter’s response to COVID-19, visit www.beckmancoulter.com/coronavirus.

References:

1. https://www.immunology.ox.ac.uk/covid-19/literature-digest-old/the-potential-role-of-il-6-in-monitoring-severe-case-of-coronavirus-disease-2019 

2. https://link.springer.com/article/10.1007/s00134-020-05991-x

3. Maurizio, C at al. "Early Predictors of Clinical Deterioration in a Cohort of 239 Patients Hospitalized for Covid-19 Infection in Lombardy, Italy." Journal of Clinical Medicine. Published: 20 May 2020. 

4. Zhou F. et al., Clinical course and risk factors for mortality of adult inpatients with COVID-19 in Wuhan, China: a retrospective cohort study. Lancet. 2020 Mar 28;395(10229):1054-1062. Epub 2020 Mar 11. 

5. Wan S. et al., Characteristics of lymphocyte subsets and cytokines in peripheral blood of 123 hospitalized patients with 2019 novel coronavirus pneumonia (NCP). Preprint from medRxiv, 11 Feb 2020.

6. https://www.who.int/docs/default-source/wpro---documents/countries/china/covid-19-briefing-nhc/1-clinical-protocols-for-the-diagnosis-and-treatment-of-covid-19-v7.pdf?sfvrsn=c6cbfba4_2

7. https://infektiologie.co.at/wp-content/uploads/2020/03/infectious_disease_artikel_corona_17-03-20.pdf

8. https://www.idsociety.org/COVID19guidelines and https://www.drugs.com/history/actemra.html

9. Mehta P, McAuley DF, Brown, M, Sanchez E, Tattersall RS, Manson JJ et al. COVID-19: consider cytokine storm syndromes and immunosuppression. The Lancet. VOLUME 395, ISSUE 10229, P1033-1034. Published: March 16, 2020. DOI: https://doi.org/10.1016/S0140-6736(20)30628-0.

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