Wren Laboratories has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its new saliva-based PCR laboratory diagnostic test for coronavirus.
The Wren PCR Saliva Test has been developed for the determination of infection from Covid-19 or SARS-CoV-2 virus.
Wren Laboratories stated that it is the first US lab to secure approval for a saliva-based PCR diagnostic test combined with a collection device.
In order to reassure the correct completion of the collection of the sample and the stabilisation of the sample, the collection device changes the sample’s colour.
The collection device facilitates to gather samples at home or office without medical supervision and easily transport at room temperature.
Wren’s test, which requires one to two minutes for the collection of saliva, can be carried out without the guidance or assistance of medical personnel.
According to Wren Laboratories, results will be delivered within one day after the testing kits reaching its facility.
Wren PCR Saliva Test has a shelf life of 12 months
With a shelf life of 12 months, the test kits avoid concerns about short expiry dates, allowing their usage when required.
The test has been developed for employers, educational institutions, healthcare facilities and long-term care facilities, where regular testing and rapid results are required.
Wren is also providing the TAPS passporting system, which offers testing subjects with a mobile app to track their testing status and get updates on their smartphones.
Wren Laboratories medical and scientific consultant Dr Irvin Modlin said: “Testing continues to be in very high demand and we are pleased that Wren can contribute to the global fight against Covid-19 with this ground-breaking new saliva-based PCR test, which combines the highest levels of accuracy with a device which is not only simple to use in a workplace, school or home but easy to transport without the need for any dry ice or refrigeration.
“We are partnering with businesses, schools, local and state healthcare providers and sporting authorities to support testing efforts.”
Recently, Quansys Biosciences secured FDA EUA status for its laboratory-based SARS-CoV-2 IgG antibody test.
