Everlywell announced today that it received FDA emergency use authorization for its COVID-19 test home collection kit DTC.
Under EUA, the home collection kit made by Everlywell can now be used directly by individuals who are not experiencing symptoms and have no suspected exposure and who are without a doctor’s prescription, according to a news release.
Austin, Texas-based Everlywell received its first EUA for the home collection kit in May 2020 with an indication for use by individuals at home who have been screened using an online questionnaire that is reviewed by a healthcare provider. The collection kit would then be sent to specified laboratories for COVID-19 testing. It launched the kit the following month.
The mail-in home collection kit for COVID-19 testing is suitable for anyone 18 years old and up and is processed using rt-PCR technology to identify the presence of the virus in individuals who are symptomatic or asymptomatic.