Press release

FDA Authorizes LetsGetChecked’s Home Collection Coronavirus (COVID-19) Test For Use on Minors

0
Sponsored by Businesswire

LetsGetChecked, a leading virtual care company, announces today the authorization of its home collection Coronavirus (COVID-19) test for use on anyone age two years and older with guardians supervising the self collection by minors ages 12 to 18 years and performing the sample collection for children ages two to 11 years. The recent Emergency Use Authorization (EUA) issued by the Food and Drug Administration (FDA) expands access to home collection testing for minors to allow a wider population to understand their health status and contain the spread of Coronavirus among children. Following the May 2020 FDA EUA for the LetsGetChecked Coronavirus (COVID-19) home collection test and the March 2021 FDA EUA for direct-to-consumer purchasing without a prescription, this updated authorization for minors will support a safe return to school, play, travel, and more.

Using the company’s end-to-end model, LetsGetChecked offers a FDA EUA authorized Coronavirus (COVID-19) home collection testing solution. The Coronavirus (COVID-19) home collection test incorporates a nasal swab and PCR lab analysis with convenient and secure results in 24-72 hours after lab receipt. Unlike serology tests that detect the presence of antibodies or viral antigens, the test determines the presence or absence of SARS-CoV-2 viral RNA. Under this re-issued LetsGetChecked authorization, children aged 12 to 18 years can self collect under adult supervision, and samples from children two to 11 years can be collected with adult assistance.

The ability to test minors for Coronavirus using LetsGetChecked’s platform will provide parents and guardians increased peace of mind as the country reopens, and children gather in-person and return to the classroom.

“As we begin to resume pre-pandemic activities, testing young people for active Coronavirus infections using gold-standard molecular diagnostic analysis is essential and critical for public health,” said Peter Foley, LetsGetChecked Founder and CEO. “With the EUA of this new indication, we have the opportunity to support an even larger portion of the American population with testing to increase confidence during the back-to-school season and beyond.”

The home collection Coronavirus (COVID-19) test is available for purchase starting at $89 per test 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 virtual care company that allows customers to manage their health from home, providing direct access to telehealth services, pharmacy, and at-home diagnostics for a wide range of health conditions including Sexual Health, Cholesterol, Diabetes, Thyroid, Coronavirus (COVID-19), and more. Founded in 2015, the company empowers people with the care they need to live longer, happier lives. Today, LetsGetChecked is a leader in healthcare innovation with an end-to-end model including manufacturing, logistics, lab analysis, affiliated physician support, and prescription fulfillment, which provides a seamless user experience and a convenient, reliable and secure healthcare experience.

LetsGetChecked is available nationwide in the United States and most EU countries. It is co-headquartered in Dublin and New York, with teammates all over the world. To learn more visit www.letsgetchecked.com.