The US FDA has issued a fast-track approval of a diagnostic kit of the latest strain of coronavirus. Currently, the federal health agency has permitted state health laboratories to use the screening prototype. The approval will accelerate efforts in the U.S. to recognize new cases of the virus, that has diseased up to 25,000 people across the world. So far, experts have sent all specimens from suspicious instances to the Centers for Disease Control and Prevention for screening. Stephen Hahn, the FDA commissioner, said the potential to give out this diagnostic test to certified labs is a crucial footstep ahead in securing the public health.
Well, this time, the FDA has bypassed the standard regulatory channels and approved the test under a EUA (Emergency Use Authorization). This channel permits the use of pharmaceutical products in life-menacing conditions when no permitted choices are available. Apart from this, it is not the first time; the FDA has approved a screening kit in an emergency. Before this, it has permitted emergency authorizations for assessments for Zika, Ebola, and MERS. Until now, around 260 people are under surveillance, citing the latest strain of coronavirus in the U.S. According to the health officials, for now, diagnosed cases, account for 11 people, and remaining have revealed negative outcomes.
On Monday, the Centers for Disease Control and Prevention has had forwarded a request for EUA to the FDA. Director of the CDC’s NCIRD said the approval would considerably develop the U.S.’s potential to examine people supposed of having the infection. She added the CDC has already started deploying the test kit to the International Reagent Resource. It is the main distributor for diagnostic tests, so it would be available as shortly as approval came. On Wednesday, the CDC has shipped coronavirus tests to the U.S. and global labs, including central and local health departments. This dispersal of the tests will allow departments to recognize new instances at a rapid pace. The CDC has noted it is looking ahead to produce more kits and deploy them in the future.