Spectrum Solutions' system first to receive FDA emergency use authorization
DUBLIN, May 6, 2021 /PRNewswire/ -- A saliva collection kit that uses a pain-free method to test for COVID-19 is being distributed in Europe for the first time by RxBIO, a leading medical device distribution company.
Spectrum Solutions' SDNA saliva collection kit offers a comfortable and more accurate alternative to the painful nasal swab test method for COVID-19. The kit received a CE Mark in December 2020 and is the first saliva-based system to receive Emergency Use Authorization for COVID-19 testing by the U.S. Food and Drug Administration.
The launch of Spectrum's SDNA-2000 and SDNA-3000 Saliva Collection Devices in Europe means citizens have access to an effective saliva-based COVID-19 test option, with 99.998 percent accuracy. The device is so reliable that Major League Baseball uses Spectrum's SDNA-1000 saliva collection kits to test all players and staff.
"We are thrilled to partner with Spectrum Solutions to offer individuals an alternative option at a time when testing for COVID-19 is at a crucial stage," said Alfan Jetha, RxBIO's CEO. "As the vaccination program rolls out across the country, daily testing is more important than ever to prevent viral spread and Spectrum Solutions is a leader in molecular diagnostic testing."
Spectrum's SDNA saliva collection device is a three-component kit that enables self-collection of saliva samples. The device has the ability to 100 percent inactivate the live virus at ambient temperatures, mitigating any risk of infection throughout the testing process.Samples are preserved for 10 days post-collection without any degradation of sample efficacy and do not require temperature-controlled storage or transport. The kits can be used in a variety of scenarios, including at-home testing by individuals or mass testing by organizations.
"Testing for COVID-19 should be accurate, efficient, user-friendly and minimize user collection errors – those are hallmarks of Spectrum Solutions' saliva collection device," said Jasmin Jetha, President and COO for RxBIO.
"At Spectrum, we engineered our revolutionary saliva-based PCR testing kits for early detection accuracy and safety. No trade-offs. After all, if you display symptoms, you have already exposed others to possible infection," said Stephen Fanning, President and Chief Executive Officer for Spectrum Solutions. "Our highly sensitive formulation is able to detect infections from saliva samples measuring as low as 200 copies/ml with viral neutralization in contrast to lateral flow rapid antigen testing requiring a minimum of 10,000-20,000 copies/ml."
RxBIO is a Canadian biotech distribution company with its EU headquarters in Dublin Ireland with expertise in providing medical devices and personal protective equipment to healthcare facilities and communities across Europe, the UK and North America. With its global infrastructure and extensive distribution channels, RxBIO connects healthcare professionals around the world with cutting edge technology and innovative solutions.
RxBIO is part of an extensive portfolio of integrated healthcare companies involved in pharmacy, clinical trials, regulatory, healthcare distribution and virtual care services.
Headquartered in Salt Lake City, the U.S. state of 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 and product manufacturing, molding, chemical formulation, packaging design, customized kitting, and direct-to-user fulfillment. Its bio-sample collection devices, patented technologies, and dedicated services deliver measurable process optimization, unprecedented efficiency, and unmatched global scalability.