Faster Coronavirus-Test Results Coming With FDA Rule Changes

FDA rule changes that took effect Sunday mean coronavirus-testing labs will no longer have to send test samples to the CDC to get confirmation.
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Faster coronavirus test results should be on the way after the Food and Drug Administration implemented a rule change allowing test results to be confirmed without first being sent to the Centers for Disease Control and Prevention. 

The FDA determined that there is "a significant potential for a public health emergency that has a significant potential to affect national security or the health and security of U.S. citizens." That led the agency to the decision to loosen regulations. 

The new review template is for use only by Clinical Laboratory Improvement Amendment certified high-complexity laboratories that have experience developing and validating molecular diagnostics for viral pathogens. 

The accelerated emergency-use authorization is in effect until further notice, until the public-health emergency is terminated, or the FDA revokes the authorization, according to the agency's rules.

Last week, President Donald Trump declared a national emergency, which freed up $50 billion in federal resources to help combat the pandemic in the U.S. 

As part of the declaration, Trump said 1.4 million tests would be available by this week with 5 million expected by the end of the month.  

The administration has been criticized for a perceived slow response to the pandemic, which began in China's Wuhan province in January. 

Meantime, the science-services provider Thermo Fisher  (TMO) - Get Report said it received emergency-use authorization from the Food and Drug Administration to market its diagnostic test for the coronavirus. The company hopes to produce 5 million tests a week in April.

The White House has been in contact with Congress concerning a stimulus package for the economy in the wake of the pandemic. Panic about spreading the virus has resulted in grocery-market runs and empty store shelves.