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Roche’s SARS-CoV-2 test for people not experiencing symptoms received an emergency use authorization from the U.S. FDA, the company announced Tuesday, upholding federal guidance to expand diagnostic tools to tamp down asymptomatic spread.
The cobas SARS-CoV-2 test is an RT-PCR test conducted by nasal, nasopharyngeal, and oropharyngeal swab samples from any person, including suspected infections or other reasons to suspect infection, per a news release.
“One of the key strategies to reduce COVID-19 transmission is to stop the silent spread of disease early,” said Cindy Perettie, head of molecular lab, Roche Diagnostics Solutions, in a news release. “Expanding highly sensitive testing to include people who are at risk of exposure but do not show symptoms will help guide contact tracing, isolation and surveillance requirements, which are crucial for public health and the safe reopening of communities.”
Roche did not immediately respond to a request for comment.
A CDC model from January suggested asymptomatic infections account for more than half of all coronavirus cases. The model, published in JAMA Network Open, showed that an estimated 59% of all coronavirus cases come from those who are asymptomatic, including 35% who are presymptomatic — meaning they initially don’t show symptoms but eventually develop them — and 24% who never develop any signs of symptoms of COVID-19.
Study authors had said identifying and isolating people with symptomatic infections alone would not control the ongoing virus spread.
Fox News’ Madeline Farber contributed to this report.
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