Labcorp COVID-19 PCR Test Home Collection Kit Receives FDA Emergency Authorization for Ages 2-17

Labcorp has announced that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for ages 2-17. The authorization expands the use of Pixel by Labcorp to children and adolescents 2 years of age and older when purchased by a parent or guardian.

“Expanding access of our Pixel by Labcorp COVID-19 Test Home Collection Kit to include younger populations fills an important need as people seek to resume life activities safely,” said Brian Caveney, M.D., chief medical officer and president of Labcorp Diagnostics. “This is welcome news as children and parents look forward to summer activities, camps, travel and the upcoming school year.”

Pixel by Labcorp COVID-19 PCR Home Collection Kit uses the same PCR test trusted by doctors and hospitals across the country. Individuals age 14-17 can self-collect with adult supervision, and children between the ages of 2 and 13 will need adult assistance to collect their sample.

Beginning in late May, parents and guardians can request a kit for children 2 years of age and older directly through www.pixel.labcorp.com. Once the request is received by Labcorp, a kit will be shipped to the individual’s home via FedEx. For adults 18 and over, the Pixel by Labcorp COVID-19 PCR Test Home Collection Kit is also available in over 6,000 pharmacies nationwide.

Labcorp offers its Pixel by Labcorp COVID-19 PCR Test Home Collection Kit for zero upfront costs when clinical guidelines are met. Visit Labcorp’s COVID-19 website to learn about the company’s testing and drug development offerings.

The Pixel by Labcorp COVID-19 PCR Test Home Collection Kit has not been FDA-cleared or approved, but has been authorized for emergency use by FDA under an EUA, and has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. Emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.