FDA Gives Emergency Approval for Saliva-Based COVID Test

BRANFORD, CT. –  Wren Laboratories, a CLIA-certified laboratory, has been granted an emergency use authorization by the U.S. Food and Drug Administration for its new proprietary saliva-based PCR laboratory diagnostic test to determine infection from COVID-19 (SARS-CoV-2). 

Wren Laboratories is 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.

The WREN PCR SALIVA TEST is highly sensitive and yields results and accuracy (>99 percent) as reliable and effective as the FDA's previous gold-standard, the nasopharyngeal PCR swabbing tests.  Saliva-based testing is far simpler to use since it only involves collection of a teaspoon equivalent of saliva. In addition, it is noninvasive as compared to the insertion of nasopharyngeal swabs.

The WREN PCR SALIVA TEST takes 1-2 minutes to collect the saliva and can be used without the guidance or assistance of medical personnel. Results will normally be provided within 24 hours after the testing kits are received at Wren Laboratories. The test kit has a shelf life of 12 months ensuring that tests can be used when needed without concern about short expiry dates.

“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,” said Irvin M. Modlin, MD, PhD, DSc, Wren Laboratories medical and scientific consultant. “We are partnering with businesses, schools, local and state healthcare providers and sporting authorities to support testing efforts.”

The WREN PCR SALIVA TEST kits are available for employers, educational institutions, healthcare facilities and long-term care facilities where regular testing and rapid results are needed. Real time information is critical to effective clinical management of both individuals and businesses.

Wren also offers the unique TAPS Passporting System that provides testing subjects 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.