IRB Approval for Saliva Multi-Omics Discovery, Detection, & Diagnostic Innovation

PRESS RELEASE
Leslie Titus Bryant
May 25, 2022

SALT LAKE CITY, UTAH—Spectrum Solutions, LLC today announced its medical science division has received independent institutional review board (IRB) approval from Sterling IRB to drive saliva-based multi-omic discovery, detection, and diagnostic innovation. This broad-reaching IRB clearance highlights a focus on noninvasive molecular diagnostic and antigen-based multiplex RT-PCR testing using human saliva collected, stabilized, and amplified with the Spectrum saliva self-collection system under the direction of principal investigator and Spectrum’s Chief Science Officer, David J Vigerust, Ph.D.

At the start of the pandemic, Spectrum Solutions was the first to push the boundaries of discovery and expand the nation’s diagnostic awareness to a safer option using saliva. As a result, Spectrum’s noninvasive saliva self-collection innovation was the first to receive FDA Emergency Use Authorization (EUA) for saliva-based COVID-19 testing. The vast benefits of this advance in clinical diagnostic healthcare using saliva continue to reach across the multiverse of omics and ologies impacting patient outcomes worldwide.

“We are excited to see testing service providers, medical facilities, and laboratories around the globe embracing and favoring saliva-based testing using Spectrum’s innovation for its unparalleled ease-of-use and safety,” said Rohit Gupta, Chief Medical Officer at Spectrum Solutions.

Among others, this study highlights two key elements to advancing, modernizing, and safely managing remote care. First, the early detection and in-device neutralization of multiple pathogens in a single saliva test, and second, the importance of consistent, robust post-collection sample stability at ambient temperatures offering stress-free storage and extended transport solutions.

> Read this release on the BusinessWire.com

IRB Approval for Saliva Multi-Omics Discovery, Detection, & Diagnostic Innovation

PRESS RELEASE
Leslie Titus Bryant
May 25, 2022

SALT LAKE CITY, UTAH—Spectrum Solutions, LLC today announced its medical science division has received independent institutional review board (IRB) approval from Sterling IRB to drive saliva-based multi-omic discovery, detection, and diagnostic innovation. This broad-reaching IRB clearance highlights a focus on noninvasive molecular diagnostic and antigen-based multiplex RT-PCR testing using human saliva collected, stabilized, and amplified with the Spectrum saliva self-collection system under the direction of principal investigator and Spectrum’s Chief Science Officer, David J Vigerust, Ph.D.

At the start of the pandemic, Spectrum Solutions was the first to push the boundaries of discovery and expand the nation’s diagnostic awareness to a safer option using saliva. As a result, Spectrum’s noninvasive saliva self-collection innovation was the first to receive FDA Emergency Use Authorization (EUA) for saliva-based COVID-19 testing. The vast benefits of this advance in clinical diagnostic healthcare using saliva continue to reach across the multiverse of omics and ologies impacting patient outcomes worldwide.

“We are excited to see testing service providers, medical facilities, and laboratories around the globe embracing and favoring saliva-based testing using Spectrum’s innovation for its unparalleled ease-of-use and safety,” said Rohit Gupta, Chief Medical Officer at Spectrum Solutions.

Among others, this study highlights two key elements to advancing, modernizing, and safely managing remote care. First, the early detection and in-device neutralization of multiple pathogens in a single saliva test, and second, the importance of consistent, robust post-collection sample stability at ambient temperatures offering stress-free storage and extended transport solutions.

>Read this release on the BusinessWire.com

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 laboratory medicine life science company using its focused industry expertise to drive noninvasive molecular diagnostic and screening IVD innovation. Our pioneering research, products, engineering, and development-to-delivery test kit commercialization 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 about our expertise by visiting our three fully integrated division pages: 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 laboratory medicine life science company using its focused industry expertise to drive noninvasive molecular diagnostic and screening IVD innovation. Our pioneering research, products, engineering, and development-to-delivery test kit commercialization 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 about our expertise by visiting our three fully integrated division pages: 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.

2022-06-30T01:36:39+00:00
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