The US Food and Drug Administration (FDA) has expanded the Emergency Use Authorisation (EUA) of LetsGetChecked’s Covid-19 test for at-home use to children aged two years and above.
As per the latest authorisation, adults can obtain the nasal swab sample for the test from children aged two to 11 years, while those aged 12 to 18 years can self-collect the sample at home under adult supervision.
The EUA expansion will increase access to home-based testing for minors, enabling a broader population to assess their health status and helping to contain the Covid-19 spread among children.
In May last year, the FDA granted EUA to the LetsGetChecked Covid-19 home collection test.
The FDA updated the EUA for direct-to-consumer purchase of the test, without requiring a prescription, this March.
The polymerase chain reaction lab-based test can deliver results within 24 to 72 hours on receiving the sample by the lab.
As compared to serology tests, which check for the presence of antibodies or viral antigens, the LetsGetChecked test analyses the presence or absence of SARS-CoV-2 viral RNA.
LetsGetChecked founder and CEO Peter Foley said: “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.
“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 test is available at a price range starting from $89 per test.
A virtual care company, LetsGetChecked offers direct access to telehealth services, pharmacy and at-home diagnostics for sexual health, cholesterol, diabetes, thyroid and Covid-19, among others.
Founded in 2015, the company has operations across the US and in several European Union countries.