FIRST DEVICE EUA AUTHORIZATION BY FDA FOR SALIVA-BASED COVID-19 TESTING:

Spectrum Solutions Secures Emergency Use Authorization (EUA) for SDNA-1000

Leslie Titus Bryant Spectrum Solutions Spokesman By: Leslie Titus Bryant
October 08, 2020
#partoftheSolution

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.

Spectrum Solutions Manufactures First EUA Authorized SDNA-1000 Saliva Collection Device

SPECTRUM SOLUTIONS SDNA-1000 EUA Authorized Saliva Collection System Manufactured in DRAPER, UT – SEPTEMBER 21, 2020 (Photo by George Frey/Getty Images)

FIRST DEVICE EUA AUTHORIZATION BY FDA FOR SALIVA-BASED COVID-19 TESTING:

Spectrum Solutions Secures Emergency Use Authorization (EUA) for SDNA-1000

By: Leslie Titus Bryant
October 08, 2020
#partoftheSolution

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.

Spectrum Solutions Manufactures First EUA Authorized SDNA-1000 Saliva Collection Device

SPECTRUM SOLUTIONS SDNA-1000 EUA Authorized Saliva Collection System Manufactured in DRAPER, UT – SEPTEMBER 21, 2020 (Photo by George Frey/Getty Images)

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.”

Spectrum Solutions Manufactures Only FDA Authorized Saliva Collection Device for COVID-19 Testing Integration

Spectrum Solutions provides only FDA Authorized saliva collection system for COVID-19 testing integration authorized for at-home sample self-collection. | © 2020 Spectrum Solutions, LLC

Product Distribution Updates
Product Distribution Updates

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.”

Spectrum Solutions Manufactures Only FDA Authorized Saliva Collection Device for COVID-19 Testing Integration

Spectrum Solutions provides only FDA Authorized saliva collection system for COVID-19 testing integration authorized for at-home sample self-collection. | © 2020 Spectrum Solutions, LLC

Product Distribution Updates

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Who is Spectrum Solutions?

Headquartered in Salt Lake City, Utah, Spectrum 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. A single-source provider of innovative medical device engineering & product manufacturing, molding, chemical formulation, packaging design, customized kitting, & direct-to-user fulfillment, Spectrum’s bio-sample collection devices, patented technologies, and dedicated services deliver measurable process optimization, unprecedented efficiency, and unmatched global scalability.

#partoftheSolution

Leslie Titus Bryant Spectrum Solutions SpokesmanSpectrum Corporate Spokesman
Leslie Titus Bryant
Director of Marketing & Brand
admin@spectrumsolution.com

Tim Rush Public Relations, Springboard 5Media Contact
Tim Rush, Springboard5
801-208-1100
tim.rush@springboard5.com

Get to Know Our #PartoftheSolution

Who is Spectrum Solutions?

Headquartered in Salt Lake City, Utah, Spectrum Solutions is a life science and medical device manufacturing company that focuses 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.

#partoftheSolution

Leslie Titus Bryant Spectrum Solutions SpokesmanSpectrum Corporate Spokesman
Leslie Titus Bryant
Director of Marketing & Brand
admin@spectrumsolution.com

Tim Rush Public Relations, Springboard 5Media Contact
Tim Rush, Springboard5
801-208-1100
tim.rush@springboard5.com

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Health is a dynamic state of wellbeing. Healthcare providers and researchers have long believed that changes in our saliva record our ongoing state-of-health story. This encrypted source of individual truth, and how to best use it, delivers us all a quicker path to informed decisions and treatments free of adverse reactions.

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.

  • Saliva provides the earliest path to critical detection and diagnosis
  • Saliva contains the entire library of proteins, hormones, antibodies, and other molecular compounds measured in routine blood tests
  • First EUA authorized saliva collection device for COVID-19 testing & authorized device for direct-to-patient at-home sample self-collection
  • Used in supervised & unsupervised sample collection LDT workflows of symptomatic & asymptomatic users
  • Pain-free, non-invasive, & safe – ideal for those needing frequent & repeat testing
  • In-device live virus inactivation at ambient temps (COVID-19 EUA validated data)
  • Eliminates hooded containment of samples arriving at the testing lab
  • No temperature-controlled storage or transport of collected saliva samples
  • Single device for DNA & viral RNA applications
  • Safest collection approach & most robust biomaterial for detecting COVID-19
  • Delivers 99.998% highest levels of testing accuracy & sensitivity
  • Formulation identifies infections at its earliest stage from as few as 200 copies/ml (lateral flow rapid tests need 10,000-20,000 copies/ml)
  • A single preserved saliva sample provides opportunity for multiple tests
  • Over two weeks of post-collection stability with no degradation in sample efficacy
  • System maintains critical bio-sample consistency
  • Mass-testing scalability & easy device integration using validated and supported processes
  • Mitigates any risk of infection throughout the testing process
  • Pinpoint life-cycle stage of active viral infection
  • Eliminates UN3373 shipping designation with clearance from USPS, FedEx, & UPS
  • Delivers the highest levels of testing accuracy using qualified extraction chemistries
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