Eurofins (Paris:ERF.PA) announced today that it received FDA emergency use authorization (EUA) for its direct-to-consumer COVID-19 test.
Luxembourg-based Eurofins’ EmpowerDX at-home COVID-19 nasal PCR test collection kit can be sold directly to consumers without a prescription to aid in testing for SARS-CoV-2, the virus causing COVID-19, according to a news release.
Currently, the kit is available through Eurofins subsidiary EmpowerDX and can be ordered online for $99, while they are also available in pharmacies across the U.S.
The kit includes step-by-step instructions for the user, a shallow nasal swab, a test tube and a pre-paid FedEx package for the simple return of samples, for which customers will receive results through a secure patient portal within 48 hours, Eurofins says.
“This product has the potential to significantly increase population testing rates and help build confidence to accelerate the return of everyday life,” Eurofins CEO Gilles Martin said in the release. “We are also working very closely with European authorities for the approval of similar direct-to-consumer products.”