FDA Authorizes Everlywell's COVID-19 Test Home Collection Kit

Everlywell announced the Everlywell COVID-19 Test Home Collection Kit DTC is now available for broad use without a prescription, including purchase by asymptomatic individuals, retailers, pharmacies, and organizations. The Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) makes the Everlywell COVID-19 Test Home Collection Kit DTC available without a doctor's prescription directly to individuals who are not experiencing symptoms and who have no suspected exposure to COVID-19.

"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," said Julia Cheek, CEO and Founder of Everlywell. "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."

The Everlywell COVID-19 Test Home Collection Kit DTC is an FDA-authorized mail-in home collection test kit for COVID-19 suitable for adults 18 years and older. The Everlywell COVID-19 Test Home Collection Kit DTC is processed using rt-PCR technology to identify the presence or absence of the virus that causes COVID-19 in both symptomatic and asymptomatic individuals. Everlywell offers several FDA-authorized COVID-19 testing options for individuals, retailers, organizations, and health plans. Those options are listed below:

"Everlywell has supported the safer reopening efforts of hundreds of schools, workplaces, and government offices across the country and assisted some of the largest health insurance companies in the nation by providing needed access to high-quality COVID-19 testing that is convenient and easy to use," Dr. Marisa Cruz, EVP of Regulatory and Clinical Affairs at Everlywell said.