Everlywell has secured an emergency use authorisation (EUA) from the US FDA for its Covid-19 Test Home Collection Kit, which can be used with certain authorised tests.
The EUA status allows the usage of Everlywell’s kit by individuals at home who were screened using an online questionnaire that is examined by a health care provider. It helps an individual to self-collect a nasal sample at home using Everlywell’s authorsed kit.
The regulator has also authorised two Covid-19 diagnostic tests, which need to be conducted at specific laboratories, for use with samples collected using the Everlywell Covid-19 kit. Under separate and individual EUAs, the regulator has authorised both tests.
Additional tests are expected to be authorised for use with the Everlywell at-home collection kit in the future, said the regulator.
The EUA status enables Everlywell Covid-19 kit to be used for the testing of a sample collected from inside the patient’s nose using the authorised self-collection kit, which contains nasal swabs to collect a sample and a tube filled with saline to ship the sample back to a specified lab.
Fulgent Therapeutics and Assurance Scientific Laboratories are authorised to test specimens collected using Everlywell kit
Fulgent Therapeutics and Assurance Scientific Laboratories are the labs authorised for the testing of specimens collected using the Everlywell at-home collection kit.
The patients can collect the results via Everlywell’s independent physician network and their online portal.
Currently, the Everlywell home-collection kit is claimed to be the only authorised Covid-19 at-home sample collection kit for use with multiple authorised Covid-19 diagnostic tests.
The FDA’s Center for Devices and Radiological Health director Dr Jeffrey Shuren said: “The authorization of a COVID-19 at-home collection kit that can be used with multiple tests at multiple labs not only provides increased patient access to tests, but also protects others from potential exposure.
“Today’s action is also another great example of public-private partnerships in which data from a privately funded study was used by industry to support an EUA request, saving precious time as we continue our fight against this pandemic.”
Recently, The FDA granted EUA status the Covid-19 laboratory developed test (LDT), at Rutgers Clinical Genomics Laboratory (RCGL).