As schools and offices prepare to come back safely this Fall, Branford, Conn.-based Wren Laboratories, an international genomics testing company, has received FDA emergency use authorization for the Wren PCR Saliva Test, the nation’s first direct-to-consumer saliva PCR COVID-19 test for ages five and over.
“We have heard from a number of schools that having a widely available saliva PCR test for children as young as 5 years old, who cannot yet be vaccinated, is a game-changer and will help facilitate the nation’s much needed Fall reopening,” says Mark Kidd, PhD, laboratory director for Wren. “This ease of saliva PCR testing coupled with high accuracy and ability to detect all currently known variants in asymptomatic and symptomatic people is a key component to instilling peace of mind and getting back to schools and workplaces and other everyday events.”
Wren’s over-the-counter saliva PCR test is available now for bulk and online purchase by schools, businesses, event organizers, and individuals and can be shipped directly to offices, schools, and homes across the United States without the need for medical prescription.
According to the company, the Wren PCR test is simple to use, has little room for error, requires just a teaspoon of saliva, and does not require any invasive nasal swabbing or similar unpleasant collection approaches. Saliva samples are collected in 2 to 3 minutes and Wren delivers digital results to the users and schools and workplaces within 24 hours of sample receipt.
Wren’s PCR test has proven to detect viral loads of <2,500NDU/mL, making it a very sensitive saliva-based assay. Over-the-counter antigen testing is significantly less accurate than traditional PCR approaches and are typically hundreds of times less sensitive than PCR assays. The CDC specifically recommends PCR to confirm infection with the virus.
In October 2020, Wren Laboratories was the first U.S. lab to receive approval for a saliva-based PCR diagnostic test combined with a proprietary collection device that changes the sample’s color, reassuring the user the collection of the sample has been completed correctly and the sample has been stabilized. The easy-to-use collection device enables samples to be collected at home or office without medical supervision and easily transported at room temperature, as the sample is automatically stabilized.
Featured image: Wren PCR Saliva Test for COVID-19 (Photo: Wren Laboratories)