UTAH GOVERNORS OFFICE:
Utah DNA Company Develops Saliva Test for COVID-19
Published: April 15, 2020
The authorization of the Spectrum Solutions saliva collection device gives patients an alternative to the intrusive swab collection typically used to test for COVID-19.
This article is part of a series about Utah-based companies going above and beyond the call of duty to help combat the coronavirus pandemic.
The company recently announced it obtained authorization from the Food and Drug Administration (FDA) an Emergency Use Authorization (EUA) for its Spectrum SDNA-1000 saliva collection device.
Patients take the top off the testing device and spit into it. “You take the top of the device, and you turn it, then it punctures the saliva into the tube,” said Stephen Fanning, CEO of Spectrum Solutions. “Our proprietary preservative kills the coronavirus, but it leaves behind what are called the ribonucleic acid, or RNA markers. By killing the virus, there’s not the issue that they can potentially become infected as a result of opening that up. More importantly, the preservative maintains the RNA markers to determine if you, in fact, have the virus.”
The study was conducted last month and immediately submitted to the FDA. For now, the saliva testing method is being used by individual health care providers under an emergency use authorization from the FDA. Each health care provider must apply for their own authorization.
“Using saliva to test for COVID-19 overcomes many of the challenges the nation faces that are inherent to current testing methods including supply shortages and risks to exposure for healthcare professionals,” said Fanning.
Spectrum plans to hire additional staff and increase the capacity of its Utah manufacturing facility to more than triple production of the SDNA-1000.
The authorization of the Spectrum Solutions saliva collection device gives patients an alternative to the intrusive swab collection typically used to test for COVID-19.
This article is part of a series about Utah-based companies going above and beyond the call of duty to help combat the coronavirus pandemic.
The company recently announced it obtained authorizationl from the Food and Drug Administration (FDA) for Emergency Use Authorization for its Spectrum SDNA-1000 saliva collection device.
Patients take the top off the testing device and spit into it. “You take the top of the device, and you turn it, then it punctures the saliva into the tube,” said Stephen Fanning, CEO of Spectrum Solutions. “Our proprietary preservative kills the coronavirus, but it leaves behind what are called the ribonucleic acid, or RNA markers. By killing the virus, there’s not the issue that they can potentially become infected as a result of opening that up. More importantly, the preservative maintains the RNA markers to determine if you, in fact, have the virus.”
The study was conducted last month and immediately submitted to the FDA. For now, the saliva testing method is being used by individual health care providers under an emergency use authorization from the FDA. Each health care provider must apply for their own authorization.
“Using saliva to test for COVID-19 overcomes many of the challenges the nation faces that are inherent to current testing methods including supply shortages and risks to exposure for healthcare professionals,” said Fanning.
Spectrum plans to hire additional staff and increase the capacity of its Utah manufacturing facility to more than triple production of the SDNA-1000.
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Noninvasive
Saliva Diagnostics
This changes everything!
Saliva analysis looks at the cellular level, the biologically active compounds, making it a true representative of what is clinically relevant. Engineered to lead the saliva collection industry, the BioMAX™ delivers the safest and most robust biosample for the earliest detection and diagnosis of disease and infection.
Since 2020 and the COVID-19 pandemic, Spectrum’s saliva collection system not only introduced, it continues to expand the molecular diagnostics industry and its understanding of the opportunities saliva offers patients, providers, and laboratories.
Noninvasive
Saliva Diagnostics
This changes everything!
Saliva analysis looks at the cellular level, the biologically active compounds, making it a true representative of what is clinically relevant. Engineered to lead the saliva collection industry, the BioMAX™ delivers the safest and most robust biosample for the earliest detection and diagnosis of disease and infection.
Since 2020 and the COVID-19 pandemic, Spectrum’s saliva collection system not only introduced, it continues to expand the molecular diagnostics industry and its understanding of the opportunities saliva offers patients, providers, and laboratories.
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