Two companies announced today that they received FDA emergency use authorizations (EUAs) for at-home COVID-19 diagnostic tests.
Luxembourg-based Eurofins’ at-home nasal PCR test is touted as a minimally invasive and quick option that offers results via email within 24 hours of sample receipt. The test is available through Eurofins’ direct-to-consumer company, EmpowerDX, and is offered online for $89.
The test was developed based on Eurofins’ previously authorized SARS-CoV-2 RT-PCR assay, which received EUA back in March. The company has ramped up its U.S. testing capacity to over 500,000 samples per week with a turnaround time averaging less than 18 hours.
Currently, the at-home test remains unavailable in New York, New Jersey, Rhode Island and Maryland, Eurofins said in a news release.
DxTerity’s EUA comes for an updated version of the company’s saliva-based test, which can be taken unsupervised from home and in the workplace. Samples are shipped for analysis and results are returned in what the company labeled a “short turnaround time,” although there is no specific timetable provided.
SafeWorkDx includes sample collection materials and a 48-hour stabilization kit for the transport of the samples, with instructions and shipping materials included.
“We have focused our efforts on adapting to the challenges of living and working during a pandemic,” DxTerity founder & CEO Bob Terbrueggen said in a release. “Our new at-home test provides the flexibility and reliability of results for people who are traveling, returning to work or simply want to ensure they can protect themselves and others.”