At-home testing company LetsGetChecked has begun selling its Covid-19 test directly to consumers in the United States after receiving "emergency use" approval from the FDA.
The Irish company expects to offer the test to customers in the EU from early next month.
The test, which uses a nasal swab and polymerase chain reaction (PCR) analysis in a laboratory to check for the presence of the virus, is available through the company’s website for $129.
The home test is processed in LetsGetChecked’s lab in the US, with results delivered to the customer’s mobile app within 24 hours of the sample being received at the lab.
The swab is transported in a special tube with a solution that deactivates the virus, protecting those who may have to handle the package.
Emergency use authorisation allows the FDA to sanction the use of unapproved medical products, or unapproved uses of approved medical products, during a declared public health emergency. The FDA states that it can be used when certain criteria are met, including that there are no adequate, approved and available alternatives.
"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," said Gwen Murphy, 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.”
Building capacity
The California-based lab has the capacity to process 300,000 tests a week but it is building towards the ability to process millions of tests a week. Testing has consistently been highlighted by health experts as key to reopening economies safely.
"With the FDA [emergency use authorisation], 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," said chief executive Peter Foley. "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."
LetsGetChecked recently offered testing free of charge to people involved in the charity TaylorMade Driving Relief tournament in the US, administering tests to players and staff.
Founded in 2015, LetsGetChecked has offered its private at-home screening model to more than 335,000 people in the past five years, with 13,500 infections and diseases detected.
Pricing for its tests, which usually require only a simple prick of the finger, start at about €50.
The company began with sexual health tests, but its current list of tests includes men and women’s health and diagnostics for vitamin levels, thyroid function and cortisol levels. It has continued to offer its standard diagnostic tests to clients during the coronavirus outbreak.
