FIRST EUA AUTHORIZED IVD DEVICE FOR SALIVA-BASED COVID-19 TESTING
Spectrum Solutions Secures Emergency Use Authorization (EUA) for SDNA-1000
Leslie Titus Bryant
October 08, 2020
New EUA Expanding Access and COVID-19 Testing Options
On October 8th, Spectrum Solutions received notice today that its SDNA-1000 saliva collection system had secured the first device U.S. Food and Drug Administration (FDA) EUA authorization for saliva-based COVID-19 testing. Spectrum’s self-contained saliva collection kit provides critical sample consistency while suspending and neutralizing viral RNA transcripts completely inactivating the live virus. Additionally, the SDNA-1000 stabilizes and protects saliva samples making both sample collection and transport for COVID-19 testing easy.
Spectrum and Rutgers Clinical Genomics Laboratory (RUCDR, now IBX) first identified, then introduced the nation to the key benefits of using saliva collected exclusively with the SDNA-1000 saliva collection system as a better viral diagnostic biomaterial for COVID-19 detection. Receiving its first EUA authorization from the FDA in March confirmed saliva’s tremendous diagnostic value and Spectrum’s innovative saliva collection device. COVID-19 saliva-based tests have already been sold and conducted using the SDNA-1000 under this previous EUA authorization held by RUCDR. However, this initial authorization limited broader access to saliva-based diagnostic testing, and restricted availability with only one testing platform ran by a single authorized lab.
First Saliva Collection System Authorized for At-Home Sample Self-Collection
This EUA authorization decision by the FDA successfully expands saliva-based testing access and availability through the validation of the SDNA-1000 saliva collection system on the broader range of platforms and assays currently being used by labs across the nation for immediate and seamless integration. Qualified commercial RNA extraction chemistries include Perkin Elmer, Thermo Fisher, Roche, and Qiagen.
“Saliva is a more robust biomaterial to facilitate molecular testing,” said Stephen Fanning, CEO of Spectrum Solutions. “Collected samples consistently demonstrate higher levels of testing accuracy, and the SDNA-1000 also offers the highest levels of safety by inactivating the live virus mitigating risks of exposure from the collection through shipping, to sample processing at the lab.”
Spectrum’s biomaterial collection system additionally provides:
- Mass-testing scalability and integration through validated and supported processes
- EUA authorized for over 10 days of post-collection stability for COVID-19 saliva samples with no degradation in sample efficacy
- EUA validated viral inactivation data
- First device authorized for at-home and unassisted sample self-collection
“The SDNA-1000 was engineered to innovate molecular diagnostic applications using saliva,” said Jeremy Johnson, VP of Engineering at Spectrum Solutions. “It’s exciting to offer labs the opportunity and freedom to explore additional DNA or viral RNA avenues for combating this pandemic and other viral infections with a safer biomaterial and a single biosample collection device.”
Why Spectrum?
Headquartered in Salt Lake City, Utah, Spectrum Solutions® is a clinical science innovation leader and a specialized laboratory test ideation and commercialization partner. Our patented, noninvasive, and multi-omic specimen collection and preservation capabilities are setting new standards of modernized care for patients, providers, and laboratories in the testing, managing, and treatment of disease.
We believe when you bridge the gap between science and real direct-to-patient medical solutions you deliver innovation with the practical power to impact and change outcomes. Learn more Spectrum Medical Science SM, Spectrum Compounding Pharmacy TM, and Spectrum Clinical Manufacturing SM.
Spectrum Corporate Spokesman
Leslie Titus Bryant
Head of Marketing & Brand
admin@spectrumsolution.com
Media Contact
Tim Rush, Springboard5
801-208-1100
tim.rush@springboard5.com
Why Spectrum?
Headquartered in Salt Lake City, Utah, Spectrum Solutions® is a clinical science innovation leader and a specialized laboratory test ideation and commercialization partner. Our patented, noninvasive, and multi-omic specimen collection and preservation capabilities are setting new standards of modernized care for patients, providers, and laboratories in the testing, managing, and treatment of disease.
We believe when you bridge the gap between science and real direct-to-patient medical solutions you deliver innovation with the practical power to impact and change outcomes. Learn more Spectrum Medical Science SM, Spectrum Compounding Pharmacy TM, and Spectrum Clinical Manufacturing SM.
Spectrum Corporate Spokesman
Leslie Titus Bryant
Head of Marketing & Brand
admin@spectrumsolution.com
Media Contact
Tim Rush, Springboard5
801-208-1100
tim.rush@springboard5.com
Bringing Baseball Back!
How you collect saliva makes a big
diagnostic difference
Increase workplace safety and build team confidence with simple and safe repeat testing programs supporting 100% accurate early detection and easy direct-to-user at-home options. Just ask the MLB, real-world, mass testing scenarios require an authorized, proven, and supported system that mitigates any risk of exposure. See how our saliva collection system is credited for “bringing baseball back” and making Salt Lake “the league’s most important city”.
™/© 2020 MLB
Bringing Baseball Back!
How you collect saliva makes a big
diagnostic difference
Increase workplace safety and build team confidence with simple and safe repeat testing programs supporting 100% accurate early detection and easy direct-to-user at-home options. Just ask the MLB, real-world, mass testing scenarios require an authorized, proven, and supported system that mitigates any risk of exposure. See how our saliva collection system is credited for “bringing baseball back” and making Salt Lake “the league’s most important city”.
™/© 2020 MLB
Noninvasive
Saliva Diagnostics
This changes everything!
Health is a dynamic state of well-being. Healthcare providers and researchers have long believed that changes in our saliva record our ongoing state-of-health story. Interestingly, saliva acts as a wide resource of genomic information useful for identifying and monitoring in real-time a disease as well as its state of progression. Saliva analysis looks at the cellular level, the biologically active compounds, making it a true representative of what is clinically relevant.
Spectrum’s technically-superior saliva collection systems have not only been engineered to lead the saliva collection industry in molecular diagnostics and clinical research applications but deliver the safest, most robust biomaterial for the earliest detection and diagnosis of disease and infection.
Noninvasive
Saliva Diagnostics
This changes everything
Health is a dynamic state of well-being. Healthcare providers and researchers have long believed that changes in our saliva record our ongoing state-of-health story. Interestingly, saliva acts as a wide resource of genomic information useful for identifying and monitoring in real-time a disease as well as its state of progression. Saliva analysis looks at the cellular level, the biologically active compounds, making it a true representative of what is clinically relevant.
Spectrum’s technically-superior saliva collection systems have not only been engineered to lead the saliva collection industry in molecular diagnostics and clinical research applications but deliver the safest, most robust biomaterial for the earliest detection and diagnosis of disease and infection.
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