Roche Gets Emergency FDA Approval to Make Coronavirus Test Kits

Medical diagnostics giant Roche says it received FDA ‘Emergency Use Authorization’ to begin mass-producing coronavirus testing kits, and processing results.

Medical diagnostics giant Roche  (RHHBY)  said it received "Emergency Use Authorization" to begin mass-producing coronavirus testing kits and also processing the results from the U.S. Food and Drug Administration.

The Geneva-based pharmaceutical company said the FDA has given it the go-ahead for what it formally called the cobas SARS-CoV-2 Test for the qualitative detection of SARS-CoV-2, the novel coronavirus.

Roche said hospitals and reference laboratories can run the test on the company's fully automated cobas 6800 and cobas 8800 systems. The cobas 6800/8800 Systems, which are used to perform the cobas SARS-CoV-2 test, provide test results in three-and-a-half hours.

The move comes as governments, hospitals and health care professionals in the U.S. and globally scramble to make testing widely available.

"Providing quality, high-volume testing capabilities will allow us to respond effectively to what the World Health Organization has characterized as a pandemic,” Roche Diagnostics CEO Thomas Schinecker said in a statement.

Key to fighting the virus has been early and accurate testing for Covid-19 before patients begin to show symptoms - not only to help treat them early but to ensure the sick and healthy are separated.

But health officials in the U.S. and other countries have expressed frustration not only over the lack of testing kits but also the lack of  coordinated systems to effectively analyze the results. 

Centers for Disease Control Head Dr. Anthony Fauci admitted to Congress this week that the U.S. system for producing the kits, administering them and processing the results was woefully inadequate.

"The system does not, is not really geared to what we need right now," Fauci said. "It is a failing. Let's admit it."

Meanwhile, President Trump and his administration continue to insist that testing is not only happening across the U.S., but is going smoothly. 

"Frankly, the testing has been going very smooth. If you go to the right agency, if you go to the right area, you get the test," Trump told reporters in the Oval Office on Thursday.

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