PRESS RELEASE:

Spectrum Solutions Receives CE Mark for its SDNA Saliva Collection Devices used for IVD Molecular Diagnostic Testing

Leslie Titus Bryant, Director of Marketing & Brand
January 06, 2021

Spectrum Solutions, LLC today announced receiving CE Mark approval for the sale and distribution of its groundbreaking SDNA saliva collection device for IVD molecular diagnostic testing throughout Europe. The European CE Mark represents a standard of excellence and regulatory validation required to sell medical devices within the European Economic area. The equivalent mark within the United States would be an FDA medical device 510k approval. This mark demonstrates a conformity with health, safety, and environmental protection standards for products sold within Europe. The Spectrum SDNA-2000 model has been approved for integration in over the counter at-home testing kits with the SDNA-3000 model approved for prescription-only molecular diagnostic IVD testing applications.

“Receiving CE Mark approval for the SDNA-2000 and SDNA-3000 is a major milestone for our company and this offers physicians, healthcare organizations, governments, and individuals needing repeat IVD diagnostic testing an easy and pain-free option,” said Stephen Fanning, CEO of Spectrum Solutions. “At-home bio-sample self-collection means staying home when you don’t feel good and limiting exposure to other harmful illnesses for those most at risk.”

The Spectrum Solutions SDNA Saliva Collection Device was the first saliva-based diagnostic testing solution to receive the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for COVID-19 testing in the United States.

Bio-samples collected with the SDNA saliva collection system consistently demonstrate higher levels of testing accuracy, provide the safest & most robust testing biomaterial, is able to pinpoint an infection’s lifecycle stage, and delivers over 10 days of post-collection stability with no degradation in sample efficacy. The device’s intuitive ease-of-use design was engineered to facilitate unsupervised testing sample self-collection virtually eliminating user collection errors.

SDNA Saliva Collection Kit_with Isolated Device

PRESS RELEASE:

Spectrum Solutions Receives CE Mark for its SDNA Saliva Collection Devices used for IVD Molecular Diagnostic Testing

Leslie Titus Bryant, Director of Marketing & Brand
January 06, 2021

Spectrum Solutions, LLC today announced receiving CE Mark approval for the sale and distribution of its groundbreaking SDNA saliva collection device for IVD molecular diagnostic testing throughout Europe. The European CE Mark represents a standard of excellence and regulatory validation required to sell medical devices within the European Economic area. The equivalent mark within the United States would be an FDA medical device 510k approval. This mark demonstrates a conformity with health, safety, and environmental protection standards for products sold within Europe. The Spectrum SDNA-2000 model has been approved for integration in over the counter at-home testing kits with the SDNA-3000 model approved for prescription-only molecular diagnostic IVD testing applications.

“Receiving CE Mark approval for the SDNA-2000 and SDNA-3000 is a major milestone for our company and this offers physicians, healthcare organizations, governments, and individuals needing repeat IVD diagnostic testing an easy and pain-free option,” said Stephen Fanning, CEO of Spectrum Solutions. “At-home bio-sample self-collection means staying home when you don’t feel good and limiting exposure to other harmful illnesses for those most at risk.”

The Spectrum Solutions SDNA Saliva Collection Device was the first saliva-based diagnostic testing solution to receive the U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA) for COVID-19 testing in the United States.

Bio-samples collected with the SDNA saliva collection system consistently demonstrate higher levels of testing accuracy, provide the safest & most robust testing biomaterial, is able to pinpoint an infection’s lifecycle stage, and delivers over 10 days of post-collection stability with no degradation in sample efficacy. The device’s intuitive ease-of-use design was engineered to facilitate unsupervised testing sample self-collection virtually eliminating user collection errors.

SDNA Saliva Collection Kit_with Isolated Device

Spectrum Receives CE Mark for SDNA Saliva Collection Devices

Access this press release from Business Wire

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

How you collect saliva makes a big diagnostic difference.
Real-world mass testing scenarios require an authorized, proven, and supported system that mitigates any risk of exposure and a company that holds a blackbelt in scalability.
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
Contact Us

Let's Connect.

#partofthesolution