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.

blank

PROUD PARTNER OF MLB

™/© 2020 MLB

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

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

Spectrum
in the News

Spectrum
in the News

Slide Predict, Diagnose, & Prevent Saliva-Based Diagnostic Solutions #SpitMatters blank

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. Additionally, saliva analysis looks at the cellular level, the biologically active compounds, making saliva 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
  • 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 any need for hood containment offering immediate sample processing upon arrival
  • Removes the need for any temperature-controlled storage or transport of 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 10 days 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
  • Eliminate UN3373 biohazard shipping designation with clearance from USPS, FedEx, & UPS
  • Delivers the highest levels of testing accuracy using qualified extraction chemistries
  • Chemistry enables easy extraction & purification for a maximum sensitivity boost
  • Proteins present in blood are also present in saliva from fluid leakage at the gum line
  • Saliva contains the entire library of proteins, hormones, antibodies, and other molecular compounds measured in routine blood tests
Questions? Let’s Connect
Contact Us

Are you a lab?
Let’s connect.

#partofthesolution

How can we help?