FDA Authorizes Everlywell's COVID-19 Test Home Collection Kit DTC for Direct to Consumer Purchase
In May 2020, the FDA issued Everlywell the first EUA of its kind for the Everlywell COVID-19 Test Home Collection Kit, which launched to consumers in June 2020.
AUSTIN, Texas, Feb. 17, 2021 /PRNewswire/ -- Everlywell, a leading digital health company, today announced that 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. In May 2020, the FDA issued Everlywell the first EUA of its kind for the Everlywell COVID-19 Test Home Collection Kit, which launched to consumers in June 2020.
"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 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. Those options are listed below:
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 the Everlywell FDA-authorized, diagnostic (PCR) COVID-19 Test Home Collection Kits DTC on shelves or online can contact [email protected].
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. Learn more here.
"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," added Dr. Marisa Cruz, EVP of Regulatory and Clinical Affairs at Everlywell.
"As Everlywell brings more FDA-authorized rapid antigen tests to market for enterprises and organizations, and explores options for commercializing and distributing rapid antigen tests for individual use at home, we are pleased to provide even greater access to diagnostic PCR tests for COVID-19 that allow individuals to safely collect their sample at home and mail them into the same labs trusted by clinics and hospitals nationwide," continued Dr. Cruz. "We appreciate the continued close partnership of the FDA in working with Everlywell to support widespread testing for SARS-CoV-2 in both symptomatic and asymptomatic individuals."
*This home collection kit has not been FDA cleared or approved. This home collection kit has been authorized by FDA under an EUA. Read more at www.everlywell.com/products/covid-19-test.
About 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. For more information please visit www.everlywell.com.
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