NEW Thermo Fisher + Spectrum SDNA-1000 Saliva Collection Method Increases COVID-19 PCR Testing Capacity to 8000 Per Day

Thermo Fisher Press Release
October 20 th, 2021

Thermo Fisher Scientific received emergency use authorization from the U.S. Food and Drug Administration to run COVID-19 tests from saliva samples collected with the Spectrum Solutions SpectrumDNA SDNA-1000 collection device on the Amplitude Solution.

SDNA saliva collection devices are self-contained systems that provide sample consistency and long-term stability while protecting DNA and RNA transcripts post-collection to help ensure accurate test results with only two milliliters of saliva. According to the company, the Amplitude Solution gives laboratories the ability to scale COVID-19 PCR testing and process up to 8,000 samples in a single day.

“With the increase of COVID-19 cases due to more transmissible variants such as the Delta variant, routine testing for SARS-CoV-2 remains an effective strategy to curb the pandemic,” says Manoj Gandhi, senior medical director of genetic testing solutions for Thermo Fisher Scientific. “By enabling labs and public health officials with additional flexibility in sample collection on a high-throughput system, we are improving their ability to meet the increased demand, which helps to monitor the spread of COVID-19 and, eventually, save lives.”

The Amplitude Solution is a molecular diagnostic system designed to help clinical labs expand testing capacity with minimal hands-on time, equipment, and staffing. Its high-throughput capabilities can be used to address testing needs for companies, schools, universities, and communities. The kit’s multi-gene target design and updated interpretive software are also designed to help labs detect SARS-CoV-2 variants.

For more information, visit Thermo Fisher Scientific.

NEW Thermo Fisher + Spectrum SDNA-1000 Saliva Collection Method Increases COVID-19 PCR Testing Capacity to 8000 Per Day

Thermo Fisher Press Release
October 20 th, 2021

Thermo Fisher Scientific received emergency use authorization from the U.S. Food and Drug Administration to run COVID-19 tests from saliva samples collected with the Spectrum Solutions SpectrumDNA SDNA-1000 collection device on the Amplitude Solution.

SDNA saliva collection devices are self-contained systems that provide sample consistency and long-term stability while protecting DNA and RNA transcripts post-collection to help ensure accurate test results with only two milliliters of saliva. According to the company, the Amplitude Solution gives laboratories the ability to scale COVID-19 PCR testing and process up to 8,000 samples in a single day.

“With the increase of COVID-19 cases due to more transmissible variants such as the Delta variant, routine testing for SARS-CoV-2 remains an effective strategy to curb the pandemic,” says Manoj Gandhi, senior medical director of genetic testing solutions for Thermo Fisher Scientific. “By enabling labs and public health officials with additional flexibility in sample collection on a high-throughput system, we are improving their ability to meet the increased demand, which helps to monitor the spread of COVID-19 and, eventually, save lives.”

The Amplitude Solution is a molecular diagnostic system designed to help clinical labs expand testing capacity with minimal hands-on time, equipment, and staffing. Its high-throughput capabilities can be used to address testing needs for companies, schools, universities, and communities. The kit’s multi-gene target design and updated interpretive software are also designed to help labs detect SARS-CoV-2 variants.

For more information, visit Thermo Fisher Scientific.

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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

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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