The Everlywell At-Home COVID-19 Test Collection Kit Receives FDA Authorization for Direct to Consumer Purchase
Digital health company Everlywell has announced that the Everlywell COVID-19 Test Home Collection Kit DTC is now available for general use without a prescription, including the 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. In May 2020, the FDA issued an Emergency Use Authorization for the at-home kit that required the individual to be screened using an online questionnaire and reviewed by a health care provider. Everlywell’s test was the first standalone sample collection kit granted a proper EUA by the FDA.
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 in all 50 U.S. states. The Everlywell COVID-19 Test Home Collection Kit DTC is processed using gold-standard 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.
Everlywell COVID-19 Test Home Collection Kit Options
COVID-19 Testing for Individuals
Adults 18 years and older in all 50 U.S. states can now purchase an Everlywell COVID-19 Test Home Collection Kit DTC in quantities up to 99.
COVID-19 Tests for Retailers
Retailers interested in carrying FDA-authorized, diagnostic (PCR) COVID-19 Test Home Collection Kits from Everlywell on shelves or online can contact email@example.com.
COVID-19 Testing and Enterprise Solutions for Organizations, Universities, and Health Plans
Organizations looking to test 100 or more participants for COVID-19 can leverage several FDA-authorized COVID-19 testing options (including PCR and rapid antigen tests) with the Everlywell digital platform to manage the logistics of test distribution and seamless digital results reporting. With a HIPAA-compliant interface and automatic reporting to mandated public health agencies, Everlywell offers a comprehensive set of COVID-19 testing solutions that can scale to accommodate the needs of each organization and help keep them safe and compliant.
Click here to learn more.
The Intended Use
From the FDA’s EUA summary, the Everlywell COVID-19 Test Home Collection Kit DTC is a direct to consumer product for self collecting an individual anterior nasal swab (nasal) specimens by individuals 18 or older at home and sending that specimen for testing with an in vitro diagnostic (IVD) molecular test that is indicated for use with the Everlywell COVID-19 Test Home Collection Kit DTC for self-collection of anterior nasal swab specimens, that is indicated for testing any individuals, including individuals without symptoms or other reasons to suspect COVID-19 and has been issued an EUA for use with Home Collection Kits, that includes the Everlywell COVID-19 Test Home Collection Kit DTC.
Testing is limited to laboratories designated by Everlywell that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, and meet the requirements to perform high complexity tests.
All test results are delivered to the user via an online portal. A healthcare provider will contact individuals with positive or invalid/indeterminate results. The direct-to-consumer home collection system is intended to enable users to access information about their COVID-19 infection status that could help determine if self-isolation or quarantine is appropriate and assist with healthcare decisions after discussion with a healthcare provider.
The Everlywell COVID-19 Test Home Collection Kit DTC is for use by adults 18 years and older to self-collect anterior nasal swab specimens, including for use by such individuals without symptoms or other reasons suspect COVID-19. The Everlywell COVID-19 Test Home Collection Kit DTC is not a substitute for visits to a healthcare provider.
When combined with an authorized test, the information provided by this kit should not be used to start, stop, or change any course of treatment unless advised by your healthcare provider.
The Everlywell COVID-19 Test Home Collection Kit DTC is only for use under the Food and Drug Administration’s Emergency Use Authorization.
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. 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.Julia Cheek, CEO and Founder of Everlywell
Everlywell believes Americans deserve access to affordable lab tests and insightful, digitally-enabled results with actionable next steps. The company connects individuals to certified labs offering a suite of validated lab tests including Cholesterol, Heart Health, Fertility, STIs, Lyme Disease, Testosterone, Thyroid and more. Everlywell also offers FDA-authorized at-home sample collection test kits for COVID-19, and was the first to provide access to at-home sample collection lab tests for fertility, high-risk HPV, and indoor & outdoor allergies. Prices are straightforward starting at $49 and tests are generally covered by Flexible Spending and Health Savings Accounts. Physician-reviewed, actionable test results from CLIA-certified labs are provided within days of sample receipt. The company also provides testing and engagement programs for health plans, healthcare organizations, and employers, including some of the largest health plans in the nation.
The Austin-based company was founded in 2015 and is advised by a Scientific Advisory Board that includes some of the nation’s top scientists from Harvard, MIT, Google and NYU. Everlywell was selected as one of Fast Company’s Most Innovative Companies in 2019.