Cytokine Storms: Pharma Giant Roche Gets US FDA Approval For New Diagnostic Test To Identify Inflammatory Response In COVID-19 Patients
Source: Cytokine Storms Jun 04, 2020 4 years, 5 months, 1 week, 2 days, 20 hours, 20 minutes ago
Cytokine Storms: The largest Swiss pharmaceuticals conglomerate Roche announced today that the US FDA had given it emergency clearance for a test identifying patients most at risk of a dangerous immune response to coronavirus infection.
A large proportion of COVID-19 patients 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.
Often extremely ill patients require mechanical ventilation, putting a huge burden on medical teams and resources over many weeks.
The pharma giant Roche said its diagnostic test will help physicians get a head start before COVID-19 inflammation takes hold as they assess their caseloads to identify priority patients and their treatment options.
In a media statement, Roche said "The US Food and Drug Administration (FDA) have issued an Emergency Use Authorization (EUA) for the Elecsys IL-6 test. 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 statement further said, "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.”
Dr Tobias Herold,from the Emergency Department at Ludwig Maximilian 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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