Roche Wins US Clearance for Virus Treatment Test

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Swiss pharmaceuticals giant Roche said Thursday the US authorities had given it emergency clearance for a test identifying patients most at risk of a dangerous immune response to coronavirus infection.

Some of those worst affected display a very severe inflammatory response to COVID-19 as the body tries to combat the infection but ends up also destroying healthy tissue and even organs such as the kidneys with life-threatening implications.

Very ill patients require mechanical ventilation, putting a huge burden on medical teams and resources over many weeks.

Roche said its test will help doctors get a head start before COVID-19 inflammation takes hold as they assess their caseloads to identify priority patients and their treatment options.

"The US Food and Drug Administration (FDA) has issued an Emergency Use Authorisation (EUA) for the Elecsys® IL-6 test," Roche said in a statement.

"This test measures levels of the biomarker interleukin 6 (IL-6) and can be used to help identify patients with confirmed COVID-19 disease who could be at high risk of intubation with mechanical ventilation."

"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," it said.

Tobias Herold, with the Emergency Department at LMU University Hospital, in Munich said the tests can be carried out on existing, widely available Roche systems and can provide "results in approximately 18 minutes, with a test throughout of up to 300 tests/hour, depending on the analyser."

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