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FDA Authorizes IL-6 Test for Early Detection of Severe COVID-19 Illness

The test measures IL-6 to identify patients with COVID-19 at high risk of intubation.

The US Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for the Elecsys IL-6 test, according to Roche. The test can be used on Roche’s “cobas e” analysers.

The test measures levels of interleukin 6 (IL-6) to identify patients with coronavirus disease 2019 (COVID-19) at high risk of intubation.

“The test can support physicians, in combination with other examinations and vital signs, to decide early on if a patient with confirmed COVID-19 illness requires mechanical ventilation,” Roche indicated in a press release.

The company noted that test results from this particular diagnostic take approximately 18 minutes, with a potential output of up to 300 tests per hour.

The immunoassay uses human serum or plasma. Under the EUA, the assay can be used to alongside clinical observation in identifying severe inflammatory response. IL-6 is released early during severe SARS-CoV-2 infection, and thus can identify severely ill patients as soon as possible.

Roche also used the release to reiterate details on the previously announced COVACTA study—a global phase 3, randomized, double-blind, placebo-controlled clinical trial to evaluate the safety and efficacy of intravenous tocilizumab (plus standard of care) in hospitalized patients with severe COVID-19 pneumonia compared to a placebo group. The test could thus identify patients with potential for benefit from the company’s tocilizumab formulation.