GetMyDNA Receives FDA EUA for COVID-19 Test Home Collection Kit for Direct-to-Consumer Purchase
COVINGTON, Ky., March 10, 2021
COVINGTON, Ky., March 10, 2021 /PRNewswire/ -- Today, the U.S. Food and Drug Administration issued emergency use authorization (EUA) to launch the GetMyDNA COVID-19 Test Home Collection Kit DTC, which is now available for broad use for both symptomatic and asymptomatic individuals with no prescription required. This news means the COVID-19 Test Home Collection Test Kit DTC is available without a doctor's prescription and can be given directly to individuals who are not experiencing symptoms from COVID-19. Negative results will be delivered directly to the individual via email, while positive results will be delivered through a healthcare provider to the individual.
"Since March 16, 2020, when Gravity Diagnostics starting processing COVID-19 samples, we always focused on how best to utilize our capacity to help those most in need of rapid gold-standard PCR testing. We purposely delayed applying for an FDA EUA for a home testing solution early on, but as things developed last year, we saw another population emerge that needed access to low-priced home testing with gold-standard PCR results. We then expedited our submission in order to attempt to serve those individuals. Today is a huge milestone for GetMyDNA. We are very thankful for the FDA and the amazing work they have done the last twelve months navigating a very complex set of challenges," said Tony Remington, co-founder, and chief executive officer of Gravity Diagnostics and GetMyDNA.
How It Works
The GetMyDNA COVID-19 Test Home Collection Kit DTC is an FDA-authorized mail-in home collection test kit for COVID-19 and is available for individuals 18 years and older in all 50 U.S. states. This test provides the gold-standard anterior nasal swab PCR (Polymerase Chain Reaction) test that checks for genetic material produced by the virus and can determine whether an asymptomatic or symptomatic individual is infected with COVID-19. A PCR test is a highly reliable, high-complexity laboratory test. The test will be available for order online at getmydna.com at $99 a kit with an introductory offer of $20 off with code LAUNCH20, making the test only $79 with free overnight shipping both ways.
"After founding Gravity Diagnostics in 2016, a CLIA-certified, CAP-accredited laboratory licensed in all 50 states, we founded our home-testing diagnostics company, GetMyDNA, in 2018. Our intention was always that home-testing solutions and telemedicine would have an important place in the future of healthcare and empower individuals to take more control over their health and wellness. We are thrilled to launch our direct-to-consumer COVID-19 home solution to serve more populations in need of accurate, timely testing as we all navigate back to work, back to school, and back to life. This is just the beginning of what we foresee GetMyDNA being able to do for consumers in all 50 states," said Julie Brazil, co-founder, and chief operating officer of Gravity Diagnostics and GetMyDNA.
An essential aspect of at-home testing is the ability to have accurate and timely results. GetMyDNA provides overnight shipping both ways while offering a competitive price. GetMyDNA is powered by Gravity Diagnostics, a CLIA-certified, CAP-accredited laboratory that provides same-day results for 99% of samples received.
GetMyDNA provides affordable and reliable diagnostic home-testing solutions backed by telemedicine across the U.S. GetMyDNA is currently focused on providing gold-standard PCR COVID-19 testing and results through their FDA-authorized COVID-19 Test Home Collection Kit DTC. In the future, the company will be adding a suite of additional home testing solutions, including a Pharmacogenomics (PGx) kit, which inspired the name GetMyDNA. Learn more at getmydna.com.
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About Gravity Diagnostics
Gravity Diagnostics is a full-service state-of-the-art CLIA-certified and CAP-accredited laboratory licensed in all 50 states providing innovative laboratory testing in the areas of COVID-19, Upper Respiratory, Toxicology, Pharmacogenomics, and Sexually Transmitted Infections. They are an advocate for physicians, patients, and their communities, supporting them with unsurpassed integrity, regulatory compliance, and clinical expertise. Gravity currently services over 750 customers from small private practices to universities to Fortune 500 companies. Learn more at gravitydiagnostics.com.
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