Offers 99% accuracy for all known variants, including emerging Delta or Indian strains
Wren Laboratories Launches First Direct-to-Consumer Saliva COVID-19 PCR Test. (Credit: Gerd Altmann from Pixabay)
As schools and offices prepare to come back safely this Fall, Wren Laboratories, an international genomics testing company, has received emergency use authorization by the U.S. Food and Drug Administration for the WREN PCR Saliva Test, the nation’s first direct-to-consumer saliva PCR COVID-19 test for ages five and over.
Wren has been offering one of the nation’s most accurate saliva tests since October 2020. Now, in response to the growing need for easy, accurate tests that detect all known variants, Wren’s new FDA-EUA authorization offers the convenience and accuracy of saliva PCR testing to help facilitate back-to-school and work conveniently, safely and cost-effectively.
“We have heard from a number of schools that having a widely available saliva PCR test for children as young as five years-old, who cannot yet be vaccinated, is a game-changer and will help facilitate the nation’s much needed Fall reopening,” said 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 U.S. without prescription or the need for medical prescription.
The Wren PCR test is simple to use, has little room for error, requires just a teaspoon of saliva and does not need any invasive nasal swabbing or similar unpleasant collection approaches. Saliva samples are collected in 2-3 minutes and Wren delivers digital results to the users and schools and workplaces within 24 hours of sample receipt.
Several education and community organizations have relied on Wren’s PCR Saliva COVID tests throughout the past year including Independence Northwest and Children’s Center of Hamden.
Independence Northwest is a disability rights organization in Connecticut that assists consumers in skilled nursing facilities and other institutions return to life in the community and also helps youth transition to and from school and work. According to the organization’s Executive Director Eileen Healy, “Access to COVID testing that is easy to administer, accurate, and provides fast turnaround has been an essential element in keeping our staff safe and allowing us to continue to serve our consumers in the community.”
The Children’s Center of Hamden, a private, nonprofit organization that provides behavioral health treatment and special education to children and teens and offers a range of outpatient, afterschool, day and residential programs. The Center uses Wren’s PCR Saliva Test as part of its protocol with staff who have been in close contact with infected people. “Access to accurate and easy to use tests provides faster peace of mind, is in line with our safety protocols, and has also reduced absenteeism,” said The Children’s Center of Hamden Chief Executive Officer Selma N. Ward.
With some of the nation’s most accurate results, Wren’s PCR test has proven to detect viral loads of <2,500NDU/mL, the most sensitive saliva-based assay on the market. 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.
Organizations reviewing their testing protocols should consider:
Regular testing builds confidence: Testing provides peace of mind to help Americans get back to the office, school and other life events. With the most accurate results available, and effectiveness in detecting all known variants, Wren’s PCR test provides the peace of mind that is needed now to get back to work and school.
Easy access and long shelf life: Wren’s saliva collection kits are available for online purchase for consumers and are shelf stable for more than one year making them ideal for schools, businesses and anyone who needs a regular testing program.
Clear digital results: In many settings, people need to show proof of negative tests before returning to work, school, travel or other large gatherings. Wren’s TAPS (Testing and Passporting Solution) provides testers with a secure mobile app to track their testing status and receive updates on their smartphones. Employers, educational institutions and sports authorities can also use the system to track testing information on employees, students and members, initiate testing requests and receive results rapidly.
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.
Source: Company Press Release