LabCorp wins FDA clearance for at-home COVID-19 test

By LabPulse.com staff writers

April 21, 2020 -- LabCorp has received emergency use authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its Pixel by LabCorp COVID-19 at-home test kit. The kit is the first to be approved by the FDA for self-collection of samples by patients at home.

The test kit can now be used by individuals to self-collect nasal swab specimens at home if recommended by a healthcare provider after completion of a COVID-19 questionnaire, according to LabCorp. Offered through the company's Pixel by LabCorp platform, the kits will initially be available to healthcare workers and first responders who may have been exposed to COVID-19 or may be symptomatic.

Consumers will be able to access the COVID-19 self-collection kits in the coming weeks, the vendor said.

LabCorp, Ciox Health to create COVID-19 patient database
LabCorp and health information management company Ciox Health have announced a partnership to create a patient data registry to help researchers address...
OraSure wins BARDA contract for at-home coronavirus test
OraSure Technologies has received a $710,310 contract from the U.S. Biomedical Advanced Research and Development Authority (BARDA) to develop a pan-SARS-coronavirus...
Molecular testing and COVID-19: Where are we now?
As the COVID-19 pandemic accelerates, attention has been focused on how to effectively scale up the diagnostic testing that is needed to correctly manage...
FDA issues EUA for LabCorp coronavirus test
The U.S. Food and Drug Administration (FDA) on March 16 issued an emergency use authorization (EUA) to LabCorp for the company's coronavirus testing kit.
FDA gives states, vendors more power in coronavirus fight
In a move it called an "unprecedented policy," the U.S. Food and Drug Administration (FDA) on March 16 once again relaxed its regulations on diagnostics...

Copyright © 2020 LabPulse.com

Last Updated ls 4/21/2020 1:05:56 PM



Register below for our weekly Letter from the Editor to receive the latest Clinical Lab news and insights.
Email
Subscribe Today
Do you want to be a Microbiology Insider?

When LabPulse gets hot new information, our Insiders are the first to find out. Stay current in today's competitive market by receiving our exclusive free email updates.

Yes, Keep Me Current