Roche Test for Severe Covid-19 Gets Emergency FDA Approval

Roche Holding AG test to detect Covid-19 patients who are most at risk of an extreme immune reaction won emergency use clearance from the U.S. Food and Drug Administration.

The blood test, called Elecsys IL-6, can identify patients who carry the virus and who may develop respiratory distress and require intubation within 18 minutes, Roche said Thursday.

Some patients develop a severe inflammatory response called a cytokine storm, which can be deadly. The test attempts to pinpoint those most at-risk people early by measuring levels of interleukin 6 in the blood, a marker for acute inflammation. The protein acts as a messenger from some immune cells to rouse others against the infection.

“Time is specifically critical,” said Thomas Schinecker, the head of Roche’s diagnostics unit. “The test could help physicians in the quick identification of severe inflammatory response.”

Roche also makes one of the most accurate serology tests, which hunt for coronavirus antibodies in the blood to identify past infection. Both run on Roche’s laboratory analysis systems, which can handle as many as 300 tests an hour.

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