The EUA status enables to use the updated version of DxTerity’s SARS-CoV-2 RT-PCR test at home and workplace
The test is designed to detect the virus that causes Covid-19 in both symptomatic and asymptomatic individuals. (Credit: DxTerity Diagnostics Inc / PRNewswire)
Genomics company DxTerity Diagnostics has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for a new at-home saliva-based Covid-19 test called SafeWorkDx.
The EUA status has been granted for the updated version of DxTerity’s SARS-CoV-2 RT-PCR test to conduct at home and workplace under supervision.
Self-collected saliva samples will be sent for analysis to deliver results within short turnaround time.
SafeWorkDx serves as a convenient and flexible solution for at-home or on-site testing of employees, thereby enabling to avoid the spread of Covid-19 disease.
DxTerity’s SARS-CoV-2 test secured authorisation for analysing specimens collected from Covid-19 suspected individuals by their healthcare provider (HCP), as well as from individuals without symptoms or other reasons to suspect Covid-19.
SafeWorkDx offers streamlined testing process
The streamlined testing process offers sample collection materials and a 48-hour stabilisation kit with instructions and shipping materials to send samples.
The kit, which includes a SDNA-1000 saliva collection device, offers secure barcoded tracking of a specimen to de-identify and precisely trace the samples.
DxTerity founder and CEO Bob Terbrueggen said: “We have focused our efforts on adapting to the challenges of living and working during a pandemic.
“Our new at-home test provides the flexibility and reliability of results for people who are travelling, returning to work, or simply want to ensure they can protect themselves and others.”
With CLIA-licenced and CAP-accredited laboratory-based near Los Angeles, DxTerity develops rapid and affordable genomic tests for disease diagnosis and disease monitoring.
Recently, healthcare analytics and diagnostics company Genalyte has secured FDA EUA status for its rapid Covid-19 antibody test.