At-Home COVID-19 Collection Kits Authorized in the USA
A leading global life sciences company announced that the U.S. Food and Drug Administration (FDA) granted Emergency Use Authorization (EUA) for the Pixel by LabCorp™ COVID-19 Test Home Collection Kit to become the first to be available over the counter without requiring a prescription.
As of December 8, 2020, the FDA had authorized 297 coronavirus diagnostic tests, which include 228 molecular tests, 61 antibody tests, and 8 antigen tests in 2020.
The kit is currently available through the Pixel by LabCorp website, and this approval will enable LabCorp to potentially distribute the kit through retail channels.
“With the first over-the-counter at-home collection kit ever authorized by the FDA for COVID-19, we are empowering people to learn about their health and make confident decisions,” said Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, in a press release.
“With this authorization, we can help more people get tested, reduce the spread of the virus, and improve the health of our communities.”
This authorization is the latest example of LabCorp’s commitment to increase access to COVID-19 testing. The kit allows consumers to self-collect their sample in the privacy of their own home, which helps minimize transmission of the virus. Users then send the sample for processing at LabCorp.
Test results are securely delivered to the consumer via the Pixel by LabCorp portal.
The Pixel by LabCorp COVID-19 collection kit is not a substitute for visits to a healthcare professional and is for use in adults 18 and older, says the company.
Furthermore, LabCorp’s COVID-19 PCR test has not been FDA cleared or approved, has been authorized by FDA under this EUA, and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens.
The test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
LabCorp delivers world-class diagnostics solutions, brings innovative medicines to patients faster, and uses technology to improve the delivery of care.
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