SALT LAKE CITY--(BUSINESS WIRE)--Spectrum Solutions, LLC today announced the U.S. Food and Drug Administration (FDA) has extended its Emergency Use Authorization for the SDNA-1000 Saliva Collection Device to include the unsupervised self-collection of saliva for COVID-19 testing. With infection rates in the United States and around the world climbing back to serious levels from the increase in viral variants, this additional FDA authorization comes at a critical time as focus shifts back to the more reliable and 99.98% accurate PCR testing for symptomatic cases.
“We have been anticipating this new FDA authorization in favor of the noninvasive self-collection of saliva,” said Bill Phillips, COO of Spectrum Solutions. “It brings with it the opportunity for testing service providers to significantly and conveniently expand access to easy at-home COVID-19 early detection in a more over-the-counter retail approach.”
Based on the totality of scientific evidence the FDA authorization has validated the device's effectiveness in diagnosing COVID-19 by serving as a successful, noninvasive means to collect, neutralize, stabilize, and transport testing samples post-collection at ambient temperatures for over 10 days with no degradation in sample efficacy. Additionally, the FDA states there is no adequate, approved, or available alternative to the emergency use of this product.
The Spectrum Solutions SDNA-1000 saliva collection system is engineered to eliminate user collection errors, removes the need for any bio-sample temperature-controlled storage or transport, and maintains critical bio-sample consistency for PCR testing. PCR testing is a more accurate, specific, sensitive, and reliable diagnostic test compared to rapid antigen tests that continue to deliver an unacceptably high rate of both false negative and positive test results.
Spectrum Solutions was the first device to receive FDA EUA authorization for saliva-based COVID-19 testing and continues to pioneer the innovation of saliva-based diagnostics. Testing service providers, medical facilities and labs around the world continue to embrace and support saliva-based testing due to its pain-free and noninvasive sample collection. Spectrum has facilitated a number of organizations such as healthcare, education, government, and civic organizations as well as Major League Baseball, Minor League Baseball, and Little League® in developing successful, ongoing testing programs.
ABOUT SPECTRUM SOLUTIONS
Headquartered in Salt Lake City, Utah, Spectrum Solutions is a life science medical device manufacturing company focusing its fully-integrated industry expertise on creating forward-looking and scalable end-to-end solutions for clinical diagnostic projects and commercialized product plans. Spectrum is a single-source provider of innovative medical device engineering & product manufacturing, molding, chemical formulation, packaging design, customized kitting, & direct-to-user fulfillment. Its bio-sample collection devices, patented technologies, and dedicated services deliver measurable process optimization, unprecedented efficiency, and unmatched global scalability. For more information, please visit spectrumsolution.com/SDNA.
