The US Food and Drug Administration (FDA) has authorised Everlywell’s COVID-19 Test Home Collection Kit DTC for sale directly to consumers online and on shelves at retailers without a prescription.
The mail-in home collection test kit is now available for broad use, including the purchase by asymptomatic people, retailers, pharmacies, and organisations in all 50 US states.
It will help to test people who have no symptoms and have no suspected exposure to Covid-19.
Last May, the FDA had granted an emergency use authorisation (EUA) to the Everlywell COVID-19 Test Home Collection Kit, which was subsequently launched to consumers in June.
Processed using rt-PCR technology, the kit is approved for detecting the presence or absence of the virus in symptomatic and asymptomatic adults.
Everlywell CEO and founder Julia Cheek said: “With new studies showing that over half of Covid-19 cases are spread by asymptomatic carriers, we need widespread, convenient, high-quality testing capable of diagnosing Covid-19 in asymptomatic individuals to prevent further catastrophic loss of life as we begin the long process of getting America vaccinated.”
In a separate development, the US FDA has granted EUA to Assurance Scientific Laboratories’ Simplicity COVID-19 Test Home Collection Kit for direct-to-consumer sale without needing a prescription.
The kit permits adults to purchase it and collect a nasal swab sample at home. On registering the kit, the sample is sent for testing to Assurance Scientific Laboratories.
Customers will receive the test results within 48 hours of the lab receiving the sample through an online portal.
Separately, Molecular Designs has developed a PCR test for Assurance Scientific Laboratories. It can distinguish the UK variant of Covid-19.
Currently, Assurance is validating the test for clinical use and plans to make it available by the end of the month.
The company is working with the FDA and plans to submit for approval under Assurance’s existing FDA EUA.