LabCorp has now grow to be the primary firm to obtain approval to promote its COVID-19 take a look at package over-the-counter with out a prescription, in accordance with a press release from the corporate.
One of the biggest diagnostics testing corporations within the U.S., LabCorp may very well be a big competitor to corporations like EverlyWell, which obtained approvals for its at-home testing kits in May; MyLab Box, which introduced a partnership with Walmart earlier this week to promote COVID-19 take a look at kits with the large retailer; or LetsGetChecked, which has its personal at-home take a look at.
LabCorp was truly the primary firm to obtain approval from the FDA for its take a look at package, and now the corporate can promote the product by way of retail channels with out a prescription.
LabCorp’s at-home COVID-19 take a look at package is the primary to be licensed by the FDA
“With the primary over-the-counter at-home assortment package ever licensed by the FDA for COVID-19, we’re empowering individuals to study their well being and make assured selections,” mentioned Dr. Brian Caveney, chief medical officer and president of LabCorp Diagnostics, in a press release. “With this authorization, we will help extra individuals get examined, scale back the unfold of the virus and enhance the well being of our communities.”
It’s fairly inarguable that something that reduces the friction shoppers face in getting examined for SARS-CoV-2, the virus that causes COVID-19, is an efficient factor. It’s additionally in keeping with a broader push to extend healthcare entry for shoppers in an effort to scale back prices.
When prospects buy the COVID-19 take a look at package, they register the package on the corporate’s web site after which observe the directions given there. Tests outcomes are delivered by way of a company portal and a healthcare supplier is obtainable to help prospects who take a look at optimistic on easy methods to proceed with a course of remedy.
The firm mentioned its package shouldn’t be seen as an alternative choice to visits to a healthcare skilled and is meant to be used by adults 18 or older.
It’s essential to notice that the LabCorp PCR take a look at has not been cleared or accredited by the FDA and is being licensed underneath an emergency use authorization.
Everlywell positive factors first FDA authorization for a standalone, at-home, COVID-19 take a look at pattern assortment package