GetMyDNA has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Covid-19 Test Home Collection Kit DTC (direct-to-consumer).
The test, which is made available for purchase without a doctor’s prescription, is used for both symptomatic and asymptomatic individuals.`
An individual will receive negative results through an email, while positive results will be sent to a healthcare provider.
The company is offering the FDA-authorised mail-in home collection test kit for individuals 18 years and older in all 50 states across the US.
GetMyDNA test is said to offer the gold-standard anterior nasal swab polymerase chain reaction (PCR) test, which checks for genetic material generated by the virus.
The test confirms whether an asymptomatic or symptomatic individual is infected with Covid-19.
GetMyDNA and Gravity Diagnostics chief operating officer and co-founder Julie Brazil said: “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.”
GetMyDNA is supported by Gravity Diagnostics’ CLIA-certified and CAP-accredited laboratory, which offers same-day results for 99% of samples received.
The company offers diagnostic home-testing solutions supported by telemedicine across the US. It is also planning to launch a suite of additional home testing solutions, including a pharmacogenomics (PGx) kit.
The Cue OTC test is designated for use by symptomatic and asymptomatic individuals, adults and children aged two and older with adult assistance.
