FDA Authorizes LetsGetChecked’s Home Collection Coronavirus (COVID-19) Test For Direct-To-Consumer Purchase

The direct-to-consumer test is now authorized by the FDA to sell directly to consumers online and at retailers

NEW YORK--()--LetsGetChecked, a leading direct-to-consumer health testing and insights company, announces today the authorization by the Food and Drug Administration (FDA) of its Coronavirus (COVID-19) home collection test now available without a prescription. The Emergency Use Authorization (EUA) issued by the FDA expands the ability of consumers and organizations alike to access the home collection Coronavirus test by removing the need for a doctor’s prescription to obtain a test for those who do not have symptoms or suspected exposure to the virus.

“While the incredible efforts to make vaccinations available to every American by May has generated renewed hope for the future, widespread testing continues to be a critical vehicle for recovery and the reopening of the economy,” said Peter Foley, CEO and Founder of LetsGetChecked. “Research shows that the virus can be transmitted and spread by those who show no symptoms, and this authorization removes another barrier to entry for high-quality testing to a wider population.”

By allowing consumers direct access to COVID-19 testing, LetsGetChecked’s FDA DTC authorization allows Americans to conveniently collect samples where they live and work. LetsGetChecked’s home collection Coronavirus test was first approved by the FDA for use under an EUA in May 2020. The Coronavirus test incorporates a nasal swab and molecular diagnostic PCR lab analysis, which provides customers results in 24-72 hours after lab receipt.

LetsGetChecked offers multiple FDA-authorized Coronavirus testing options for individuals, businesses, retailers and more, which include:

  • Coronavirus Testing For Individuals: In all 50 states, any adult over the age of 18 can purchase the COVID-19 testing kit.
  • Coronavirus Testing For Organizations: Tailored to your organization’s needs, LetsGetChecked can provide a wholesale testing service that can be scaled from a small number of tests to large volume requests.
  • Coronavirus Testing For Retailers: Retailers interested in partnering with LetsGetChecked and its Coronavirus home collection test can contact retail@letsgetchecked.com.

“We’ve served as a critical partner for numerous workplaces, schools, and businesses to provide much-needed access to convenient and easy-to-use Coronavirus testing,” commented Derek Newell, President of LetsGetChecked. “This authorization allows for heightened access to molecular PCR diagnostic Coronavirus testing nationwide and we applaud the FDA’s support to encourage widespread testing for both asymptomatic and symptomatic Americans.”

The home collection Coronavirus test is available for purchase starting at $109 per kit on www.LetsGetChecked.com. Tests are received within 24 hours from purchase with definitive results delivered within 24-72 hours (of the sample being received by the lab).

*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 https://www.letsgetchecked.com/us/en/home-coronavirus-test/.

About LetsGetChecked:

LetsGetChecked is a leading health insights company that allows consumers direct access to a wide range of testing options and clinical support from home. Founded in 2015, the company empowers people to take an active role in their health to live longer, happier lives.

By combining health data and diagnostic results, LetsGetChecked provides rich health insights to enable better healthcare decision making. LetsGetChecked tests cover general health, men’s health, women’s health, and sexual health, and are available nationwide in the United States and most EU countries.

LetsGetChecked has corporate offices located in New York City and Dublin. For more information, visit www.letsgetchecked.com.


Alyssa Kluge


Alyssa Kluge