LabCorp, a leading global life sciences company, has announced that the U.S. Food and Drug Administration granted Emergency Use Authorization (EUA) for the use of its Covid-19 home test.
The Pixel by LabCorp Covid-19 Test Home Collection Kit will be the first to be available over-the-counter without requiring a prescription. The RT-PCR (reverse transcription polymerase chain reaction) test does not detect antibodies or immunity.
“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.
“With this authorization, we can help more people get tested, reduce the spread of the virus and improve the health of our communities.”
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.
The kit can be billed to insurance or covered by federal funds if uninsured. For those who choose not to have the test covered by an insurance company, the cost is $119.
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.
Upon purchase, users register their Pixel by LabCorp Covid-19 collection kit at the Pixel by LabCorp website and follow the instructions included.
The at-home test has a five-step process:
Complete a short eligibility survey
Choose a billing option
Receive sample collection kit via FedEx
Collect and send sample back to laboratory for testing
Access results online via Pixel by LabCorp portal
Test results are securely delivered to the consumer via the Pixel by LabCorp portal. A healthcare provider will counsel consumers who test positive to assist with healthcare treatment and further actions.
The Pixel by LabCorp Covid-19 collection kit is not a substitute for visits to a healthcare professional and is for use by adults 18 and older.
Although LabCorp’s Covid-19 PCR test has not been FDA cleared or approved, it has been authorized by FDA under an Emergency Use Authorization (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 emergency declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of Covid-19, unless the authorization is terminated or revoked sooner.
Retailers interested in selling Pixel by LabCorp Covid-19 collection kits can contact the company.
From the Triangle Business Journal:
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