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.
“One year into this pandemic, America continues to break records for COVID-19 cases and deaths. Widespread testing for COVID-19 has never been more critical,” Everlywell founder & CEO Julia Cheek said in the release. “With new studies showing that over half of COVID-19 cases are spread by asymptomatic carriers, we need widespread, convenient, high-quality testing capable of diagnosing COVID-19 in asymptomatic individuals to prevent further catastrophic loss of life as we begin the long process of getting America vaccinated.
“With the FDA’s support for this new indication, we can now serve even more Americans with COVID-19 testing that’s delivered right to their doors and available where they shop and work.”