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

Our Team, Helping your Team, get Back in the Game!

How you collect saliva makes a big diagnostic difference. To incorporate the use of saliva into COVID-19 diagnostic testing protocols or implement actual real-world mass-testing in scalable scenarios requires an authorized, proven, validated, and supported system that mitigates risk of exposure. Get your business back in the game. 

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PROUD PARTNER OF MLB

™/© 2020 MLB

Our Team, Helping Your Team, Get Back in the Game!

How you collect saliva makes a big diagnostic difference. To incorporate the use of saliva into COVID-19 diagnostic testing protocols or implement actual real-world mass-testing in scalable scenarios requires an authorized, proven, validated, and supported system that actually mitigates risk of exposure and a device engineered to increase testing accuracy. Get your business back in the game.

Providing the test kits helping keep MLB™ stars on the field.

PROUD PARTNER OF MLB

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Get to know our #partoftheSolution

About Spectrum Solutions and Spectrum DNA

Headquartered in Salt Lake City, Utah, Spectrum Solutions and its medical device and services division, Spectrum DNA, focus their concentrated industry expertise on engineering innovative end-to-end solutions for both clinical diagnostic projects and commercial product plans. A single-source provider of on-site medical device development and manufacturing, custom packaging, kitting, and direct-to-consumer fulfillment. Its biosample 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

ABOUT SPECTRUM SOLUTIONS AND SPECTRUM DNA

Headquartered in Salt Lake City, Utah, Spectrum Solutions and its medical device and services division, Spectrum DNA, focus their concentrated industry expertise on engineering innovative end-to-end solutions for both clinical diagnostic projects and commercial product plans. A single-source provider of on-site medical device development and manufacturing, custom packaging, kitting, and direct-to-consumer fulfillment. Its biosample 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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About the Product

Innovative Engineering

Spectrum-SDNA-1000-Saliva-Collection-Proud Partner of MLB2

Spectrum Solutions has manufactured over 20 million Saliva Collection devices for distribution worldwide. Spectrum’s technically superior  SDNA-1000 saliva collection device was engineered to lead the saliva collection industry in molecular diagnostics and clinical research applications delivering the safest and most robust biomaterial collection approach for the detection and diagnosis of disease or viral infection.

  • First saliva collection device to receive EUA authorization for COVID-19 testing
  • First saliva collection device FDA authorized for at-home sample collection
  • Only pain-free biosample collection option for COVID-19 testing
  • Engineered to reduce self-collection error
  • Delivers consistent high-quality, high-yield biosamples
  • 100% inactivation of the live virus
  • 100% bacteriostatic
  • Delivers over a 90% reduction in PPE usage compared to current swab collections for COVID-19 testing
  • Single device preserves both DNA and fragile viral RNA transcripts
  • Device stabilizes and extends biosample viability post-collection over 10 days with no degradation of sample efficacy extending shipping and transport options
  • Saliva collection system mitigates any risk of infection throughout the testing process
  • Pinpoint life-cycle stage of active viral infection
Questions? Let’s Connect
Spectrum-SDNA-1000-Saliva-Collection-Proud Partner of MLB2

About the Product

Innovative Engineering

Spectrum Solutions has manufactured over 20 million Saliva Collection devices for distribution worldwide. Spectrum’s technically superior  SDNA-1000 saliva collection device was engineered to lead the saliva collection industry in molecular diagnostics and clinical research applications delivering the safest and most robust biomaterial collection approach for the detection and diagnosis of disease or viral infection.

  • First saliva collection device to receive EUA authorization for COVID-19 testing
  • First saliva collection device FDA authorized for at-home sample collection
  • Only pain-free biosample collection option for COVID-19 testing
  • Engineered to reduce self-collection error
  • Delivers consistent high-quality, high-yield biosamples
  • 100% inactivation of the live virus
  • 100% bacteriostatic
  • Delivers over a 90% reduction in PPE usage compared to current swab collections for COVID-19 testing
  • Single device preserves both DNA and fragile viral RNA transcripts
  • Device stabilizes and extends biosample viability post-collection over 10 days with no degradation of sample efficacy extending shipping and transport options
  • Saliva collection system mitigates any risk of infection throughout the testing process
  • Pinpoint life-cycle stage of active viral infection
Questions? Let’s Connect