LabCorp’s At-Home COVID-19 Test Gets FDA Emergency OK for Ages 2-17
Children aged 2 and older will soon be able to get tested at home using LabCorp’s rapid coronavirus test kit.
The Burlington-based life science giant received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) for its collection kit called Pixel in children and adolescents.
According to LabCorp, it’s now the “first major commercial lab” to offer the kits to this age group when purchased by a parent or guardian without a prescription.
“Expanding access to include younger populations fills an important need as people seek to resume life activities safely,” said Brian Caveney, M.D.,J.D., chief medical officer and president of LabCorp Diagnostics.
Starting in late May, parents and guardians can request a kit for children 2 years of age and older directly from the company’s website.
The FDA authorized the at-home test for the general population last December.
Added Caveney: “This is welcome news as children and parents look forward to summer activities, camps, travel and the upcoming school year.”
The kit includes a nasal swab, a chemical solution and a testing strip. The test connects digitally to a smart phone app that displays the results and then helps interpret the results. Users can also connect with a health professional via the app.
People aged 14-17 can self-collect the test. Younger children will need adult assistance, LabCorp said.
The news comes a day after the FDA approved the use of the Pfizer vaccine for children aged 12-15.