LabCorp's home collection test to diagnose coronavirus infection will be made available to consumers in most states over the next few weeks.
In a statement outlining terms of the new authorization, the FDA emphasized that the approval exclusively applies to collection kits distributed by LabCorp. The agency has released previous notices warning consumers about fraudulent or otherwise unauthorized home test kits, which have been created and marketed by several smaller companies throughout the past month.
A coronavirus test site administrator wears personal protective equipment while collecting diagnostic samples outside an urgent care clinic in Los Angeles on April 13."Throughout this pandemic, we have been facilitating test development to ensure patients access to accurate diagnostics, which includes supporting the development of reliable and accurate at-home sample collection options," FDA Commissioner Stephen Hahn said in Tuesday's statement.
"The FDA's around-the-clock work since this outbreak began has resulted in the authorization of more than 50 diagnostic tests and engagement with over 350 test developers," he continued."Specifically, for tests that include home sample collection, we worked with LabCorp to ensure the data demonstrated from at-home patient sample collection is as safe and accurate as sample collection at a doctor's office, hospital or other testing site.
As of Tuesday afternoon, the U.S. has diagnosed more than 800,000 coronavirus cases and reported at least 43,200 deaths since the pandemic's outset, according to the most recent figures from a Johns Hopkins University tracker. So far, more than 4 million diagnostic tests have been administered at in-person testing sites nationwide over the course of the outbreak.
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