With the authorisation, ORAcollect·RNA is allowed to be used as unsupervised sample collection device along with an approved self-collection kit
DNA Genotek, a subsidiary of OraSure, has obtained the US Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for its ORAcollect·RNA saliva collection device to collect, stabilise and transport Covid-19 suspected saliva specimens.
The US regulatory authorisation for ORAcollect·RNA Saliva Collection Device is the DNA Genotek’s second EUA for its saliva collection devices, after OMNIgene·ORAL last month.
Similar to the OMNIgene·ORAL, the current authorisation also allows for the unsupervised use of the device at-home or in a healthcare setting, along with an authorised or approved self-collection kit, said the company.
DNA Genotek executive vice president and molecular solutions business unit leader Kathleen Weber said: “Accessible and accurate testing programs that include a non-invasive, saliva-based collection option will be essential throughout the duration of the Covid-19 pandemic.
“This second EUA gives our customers additional non-invasive options for SARS CoV-2 sample collection. Saliva sample collection is quick, painless, non-invasive and requires less human contact both minimizing the need for PPE and reducing exposure to potentially infected patients.”
ORAcollect·RNA is designed for both at-home and testing labs for saliva collection
The FDA authorisation indicates that DNA Genotek’s sample collection device can be used as a part of an individual regulatory authorised kit for self-collection of saliva specimens.
Also, laboratories are allowed to use ORAcollect·RNA as a crucial component of molecular/PCR tests, for collecting the saliva samples for their Covid-19 tests.
DNA Genotek provides biological sample collection products and services for human genomics and microbiome applications.
The company claimed that its Oragene•Dx and ORAcollect•Dx product lines are the first and only FDA approved saliva-based DNA collection devices for in vitro diagnostic use.
OraSure Technologies is a provider of point-of-care diagnostic tests, specimen collection devices, and microbiome laboratory and analytical services.
Apart from molecular sample collection devices for lab-based molecular/PCR Covid-19 testing, the company is also developing a lab-based oral fluid SARS-CoV-2 antibody test, and a rapid antigen self-test for Covid-19.