LabCorp mentioned on Wednesday that it has obtained Emergency Use Authorization for an over-the-counter model of its COVID-19 residence check.
With the EUA, LabCorp is ready to promote the check package on to customers with out requiring a prescription. The package is the primary over-the-counter at-home assortment package for SARS-CoV-2 to obtain EUA.
Customers can self-collect nasal swab samples and ship them in for processing at LabCorp, which is able to run the samples on its COVID-19 PCR check. Healthcare suppliers will ship constructive or invalid outcomes to sufferers, whereas detrimental outcomes might be delivered by e-mail or on-line portal.
“That is the primary package for customers to self-collect a nasal pattern for COVID-19 of their residence that doesn’t require a prescription,” Jeff Shuren, director of FDA’s Heart for Gadgets and Radiological Well being, mentioned in an announcement. “Whereas many residence assortment kits could be prescribed with a easy on-line questionnaire, this newly approved direct-to-consumer assortment package removes that step from the method, permitting anybody to gather their pattern and ship it to the lab for processing.”
“With the primary over-the-counter at-home assortment package ever approved by the FDA for COVID-19, we’re empowering folks to find out about their well being and make assured choices,” mentioned Brian Caveney, chief medical officer and president of LabCorp Diagnostics, in a separate assertion. “With this authorization, we will help extra folks get examined, scale back the unfold of the virus and enhance the well being of our communities.”
This story first appeared in our sister publication, Genomeweb.