SDNA-1000 Saliva Collection Kit used to Track Viral Variants and Successfully Detect Omicron Including Mutations

PRESS RELEASE
Leslie Titus Bryant
December 13, 2021

SALT LAKE CITY, UTAH—Spectrum Solutions, LLC today announced that COVID-19 RT-PCR saliva tests using the Spectrum SDNA-1000 for bio-sample collection will also successfully be able to detect the additional Omicron viral variant and its mutations. Initially identified in South Africa, this variant has swiftly spread into Europe and is now being detected in North America. The Omicron variant (B.1.1.529) currently contains approximately 30 different mutations.

Spectrum’s SDNA-1000 is the advanced saliva collection breakthrough innovation that not only introduced the world to the possibility of a more accurate, noninvasive, and safer viral testing solution but was also the first saliva collection device to be EUA authorized by the FDA for saliva-based PCR COVID-19 testing as well as direct-to-patient at-home testing applications that include unsupervised sample self-collection. The FDA validation of this all-in-one, patented sample collection, preservation, and transport system highlights the device’s ability to neutralize the live virus at ambient temperatures further mitigating downstream risks of exposure and spread.

“We have intently monitored mutations of the COVID-19 virus and assessed the authorized tests using our saliva collection system with the ability to detect them. According to the WHO, CDC & ECDC, ‘S-gene dropout’ can be used as a marker or signal for identifying the Omicron variant confirmed by sequencing,” said David Vu, Spectrum Solutions Vice President of Product Development. “The SDNA-1000 saliva collection device is so effective at preserving viral genetic material, it is specifically being used in testing assays commissioned by the CDC to track and identify these and previous viral variants.”

Many tests including those using raw saliva only look at a single viral transcript (N gene). Saliva testing using the EUA approved ThermoFisher TaqPath RT-PCR COVID-19 kit that includes the Spectrum SDNA-1000 for its saliva collection and sample preservation interrogates three viral transcripts (N, S, and ORF1a/b) adding to the superior performance, heightened sensitivity, and 99.98% test accuracy.

SDNA-1000 Saliva Collection Kit used to Track Viral Variants and Successfully Detect Omicron Including Mutations

PRESS RELEASE
Leslie Titus Bryant
December 13, 2021

SALT LAKE CITY, UTAH—Spectrum Solutions, LLC today announced that COVID-19 RT-PCR saliva tests using the Spectrum SDNA-1000 for bio-sample collection will also successfully be able to detect the additional Omicron viral variant and its mutations. Initially identified in South Africa, this variant has swiftly spread into Europe and is now being detected in North America. The Omicron variant (B.1.1.529) currently contains approximately 30 different mutations.

Spectrum’s SDNA-1000 is the advanced saliva collection breakthrough innovation that not only introduced the world to the possibility of a more accurate, noninvasive, and safer viral testing solution but was also the first saliva collection device to be EUA authorized by the FDA for saliva-based PCR COVID-19 testing as well as direct-to-patient at-home testing applications that include unsupervised sample self-collection. The FDA validation of this all-in-one, patented sample collection, preservation, and transport system highlights the device’s ability to neutralize the live virus at ambient temperatures further mitigating downstream risks of exposure and spread.

“We have intently monitored mutations of the COVID-19 virus and assessed the authorized tests using our saliva collection system with the ability to detect them. According to the WHO, CDC & ECDC, ‘S-gene dropout’ can be used as a marker or signal for identifying the Omicron variant confirmed by sequencing,” said David Vu, Spectrum Solutions Vice President of Product Development. “The SDNA-1000 saliva collection device is so effective at preserving viral genetic material, it is specifically being used in testing assays commissioned by the CDC to track and identify these and previous viral variants.”

Many tests including those using raw saliva only look at a single viral transcript (N gene). Saliva testing using the EUA approved ThermoFisher TaqPath RT-PCR COVID-19 kit that includes the Spectrum SDNA-1000 for its saliva collection and sample preservation interrogates three viral transcripts (N, S, and ORF1a/b) adding to the superior performance, heightened sensitivity, and 99.98% test accuracy.

Noninvasive
Saliva Diagnostics

This changes everything

Health is a dynamic state of well-being. Healthcare providers and researchers have long believed that changes in our saliva record our ongoing state-of-health story. 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
Questions, Let’s Connect!

Noninvasive
Saliva Diagnostics

This changes everything

Health is a dynamic state of well-being. Healthcare providers and researchers have long believed that changes in our saliva record our ongoing state-of-health story. 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
Questions, Let’s Connect!
Major League Baseball Logo

Bringing Baseball Back!

How you collect saliva makes a big
diagnostic difference

Increase workplace safety and build team confidence with simple and safe repeat testing programs supporting 100% accurate early detection and easy direct-to-user at-home options. Just ask the MLB, real-world, mass testing scenarios require an authorized, proven, and supported system that mitigates any risk of exposure. See how our saliva collection system is credited for bringing baseball back” and making Salt Lake “the league’s most important city”.

™/© 2020 MLB

Case Study
Major League Baseball Logo

Bringing Baseball Back!

How you collect saliva makes a big
diagnostic difference

Increase workplace safety and build team confidence with simple and safe repeat testing programs supporting 100% accurate early detection and easy direct-to-user at-home options. Just ask the MLB, real-world, mass testing scenarios require an authorized, proven, and supported system that mitigates any risk of exposure. See how our saliva collection system is credited for bringing baseball back” and making Salt Lake “the league’s most important city”.

™/© 2020 MLB

Case Study

Why Spectrum?

Headquartered in Salt Lake City, Utah, Spectrum Solutions® is a clinical science innovation leader and a specialized laboratory test ideation and commercialization partner. Our patented, noninvasive, and multi-omic specimen collection and preservation capabilities are setting new standards of modernized care for patients, providers, and laboratories in the testing, managing, and treatment of disease.

We believe when you bridge the gap between science and real direct-to-patient medical solutions you deliver innovation with the practical power to impact and change outcomes. Learn more Spectrum Medical Science SM, Spectrum Compounding Pharmacy TM, and Spectrum Clinical Manufacturing SM.

#partoftheSolution

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

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

Why Spectrum?

Headquartered in Salt Lake City, Utah, Spectrum Solutions® is a clinical science innovation leader and a specialized laboratory test ideation and commercialization partner. Our patented, noninvasive, and multi-omic specimen collection and preservation capabilities are setting new standards of modernized care for patients, providers, and laboratories in the testing, managing, and treatment of disease.

We believe when you bridge the gap between science and real direct-to-patient medical solutions you deliver innovation with the practical power to impact and change outcomes. Learn more Spectrum Medical Science SM, Spectrum Compounding Pharmacy TM, and Spectrum Clinical Manufacturing SM.

#partoftheSolution

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

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

Can we answer any questions?

Let's Connect

Contact Us

#SpitMatters

Can we answer any questions?

Let's Connect

Contact Us

#SpitMatters

Outside-of-the-Box Thinking, Inside-of-the-Box Clinical Innovation

Anywhere from customized testing solutions to new medical science product innovations–we’re here to help.

Outside-of-the-Box Thinking, Inside-of-the-Box Innovation

Anywhere from customized testing solutions to new medical science product innovations–we’re here to help.

2022-08-25T21:34:48+00:00
Go to Top