FDA EUA authorized at-home Coronavirus test is now available in the United States offering unparalleled safety and scale for consumers.
New York City (May 29, 2020) — LetsGetChecked, the leading direct-to-consumer at-home health testing and insights company, announces today the authorization of the new Coronavirus (COVID-19) Sure-track Test for at-home consumer use by the U.S. Food and Drug Administration under an EUA. The new test is authorized to serve at-risk individuals with a proprietary at-home PCR nasal swab test that delivers accurate and definitive results within 24 hours.
Offering an end-to-end model, LetsGetChecked’s new Sure-track Test introduces the most complete FDA EUA authorized Coronavirus at-home testing solution. The at-home Coronavirus (COVID-19) test incorporates a nasal swab and PCR lab analysis offering convenient and secure results in 24 hours. Unlike serology tests that detect the presence of antibodies, the at-home COVID-19 test determines the presence or absence of SARS-CoV-2 viral RNA.
LetsGetChecked’s Sure-track Test is the only FDA EUA-authorized at-home Coronavirus (COVID-19) test that owns all aspects of the testing service, including the collection kit manufacturing process, logistics, lab analysis and physician approval, offering a robust system that delivers unmatched safety and scale for customers. The at-home Coronavirus test is accompanied by LetsGetChecked’s connected platform offering 24/7 telehealth services supported by licensed healthcare professionals and timely guidance on containment and care for those who test positive.
“With the FDA EUA authorization, we are thrilled to introduce the Sure-track Test to offer convenient, secure, and highly accurate at-home testing for coronavirus to communities in need in the United States. We’ve spent years building the only true end-to-end service on the market, which allows us to deliver unparalleled service to our customers.” said Peter Foley, LetsGetChecked founder and CEO.
The company's at-home Coronavirus (COVID-19) test is designed with safety in mind at every touchpoint. After a customer self-collects a swab sample, the collection swab is placed in a special transport tube containing a solution that deactivates the virus, ensuring everyone from shipping providers to lab technicians are protected from contamination and infection. Other tests on the market use a saline solution, which heightens risk by transporting an active virus. The solution also protects the integrity of the SARS-CoV-2 RNA, which heightens accuracy.
“The coronavirus crisis has impacted everyone and we are delighted to not only introduce a reliable testing solution, but one that is safe for everyone involved in the supply chain. Our entire system was considered as part of the review process and we are delighted to have worked with the FDA to deliver a truly unique at-home Coronavirus testing service to our customers” said Gwen Murphy, PhD, MPH, and Director of Epidemiology and Clinical Studies at LetsGetChecked. “At-home testing will play a central role in ensuring a safe workplace and we are helping to develop and inform protocols with that in mind.“
With a current capacity of 300,000 units per week, LetsGetChecked’s own CLIA/CAP/BSL II certified high complexity laboratory based in Monrovia, California is building toward a capacity of millions per week in order to meet the demand of partners and individuals in all 50 states.
Prior to today’s EUA authorization from the FDA for at-home use, LetsGetChecked has worked with global leaders from today’s top companies and frontline healthcare workers to offer coronavirus tests to more than 100,000 people. Most recently, LetsGetChecked partnered with the Professional Golfers Association on the TaylorMade Driving Relief tournament to administer tests both before and during the event, assuring that players, crew, and on-site teams were safe to play for the first televised professional sports event since shutdown. The company also developed a mobile app with tracking capabilities to monitor all parties’ symptoms and temperatures. This signals LetsGetChecked's pivotal role in providing industries across all verticals a resource to test individuals nationwide and begin re-opening the country.
The Sure-track Test will be made available for purchase starting on May 28, 2020 for $129 per kit on www.LetsGetChecked.com for at-risk individuals, who meet the criteria defined by the website’s guided risk questionnaire. Tests are received within 24 hours from purchase with definitive results delivered within 24 hours (of the sample being received by the lab).
LetsGetChecked is a leading health insights company that allows consumers direct access to a wide range of testing options and clinical services 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 US, Canada, and Europe. LetsGetChecked has corporate offices located in New York City and Dublin. For more information, visit www.LetsGetChecked.com.