UTAH BUSINESS:

Utah’s Biotech Companies Changed the Course of the Pandemic

By: Elainna Ciaramella
October 21, 2020

Utah is home to more than 40 companies directly responding to the COVID-19 pandemic by way of diagnostic test manufacturing, serological test manufacturing, personal protective equipment (PPE), therapeutics, and other laboratories that are conducting various types of testing.

Wade Stevenson, VP of North American clinical marketing at BioFire Diagnostics, one of the life science leaders in Utah, says an important part of the story is that the current demand for BioFire’s testing product far exceeds the supply. While the company has been doing everything humanly possible to ramp up manufacturing and better meet demand, they’re still behind.

Currently, BioFire has over 300 roles they’re looking to fill in response to this demand, especially in manufacturing. “We are not meeting all the demand that we have–it’s been overwhelming. A big part of our response is hiring, hiring, hiring,” Stevenson says.

UTAH BUSINESS:

Utah’s Biotech Companies Changed the Course of the Pandemic

By: Elainna Ciaramella
October 21, 2020

Utah is home to more than 40 companies directly responding to the COVID-19 pandemic by way of diagnostic test manufacturing, serological test manufacturing, personal protective equipment (PPE), therapeutics, and other laboratories that are conducting various types of testing.

Wade Stevenson, VP of North American clinical marketing at BioFire Diagnostics, one of the life science leaders in Utah, says an important part of the story is that the current demand for BioFire’s testing product far exceeds the supply. While the company has been doing everything humanly possible to ramp up manufacturing and better meet demand, they’re still behind.

Currently, BioFire has over 300 roles they’re looking to fill in response to this demand, especially in manufacturing. “We are not meeting all the demand that we have–it’s been overwhelming. A big part of our response is hiring, hiring, hiring,” Stevenson says.

The Race for More Testing

Headquartered in Draper, the Spectrum campus includes Spectrum Solutions and its medical device and services division, Spectrum DNA. Before Spectrum, testing methods for the coronavirus required individuals to endure an invasive and uncomfortable swabbing of the throat and nasal cavity to gather a specimen.

“The prospect of weekly, and in many settings, daily testing, brought sharp opposition, not to mention increased risk of exposure for healthcare professionals and shortages of testing supplies,” says Bill Phillips, chief operating officer at Spectrum Solutions.

Pioneering an altogether new, pain-free alternative, Spectrum secured the first FDA EUA authorization for the use of saliva collected with their SNDA-1000 saliva collection device. “This incredible innovation additionally delivered the first FDA EUA authorization for at-home biosample collection and provides 100 percent in-device viral inactivation.”

The SDNA-1000 saliva collection device creates the most robust and safest biomaterial collection approach for the detection of COVID infections and leads the way to a new era of at-home biosample self-collection for the diagnosis of many viral infections, mitigating any risk of infection throughout the testing process, delivering over a 90 percent reduction in PPE usage compared to swabbing, saving both time and money.

Spectrum Solutions Manufactures FDA EUA Authorized SDNA-1000 Saliva Collection Kit for Coronavirus Diagnostic Testing

Spectrum Solutions Manufactures Only FDA Authorized Saliva Collection Device for COVID-19 Testing Integration | Draper, Utah. (Photo by George Frey/Getty Images)

The Race for More Testing

Headquartered in Draper, the Spectrum campus includes Spectrum Solutions and its medical device and services division, Spectrum DNA. Before Spectrum, testing methods for the coronavirus required individuals to endure an invasive and uncomfortable swabbing of the throat and nasal cavity to gather a specimen.

“The prospect of weekly, and in many settings, daily testing, brought sharp opposition, not to mention increased risk of exposure for healthcare professionals and shortages of testing supplies,” says Bill Phillips, chief operating officer at Spectrum Solutions.

Pioneering an altogether new, pain-free alternative, Spectrum secured the first FDA EUA authorization for the use of saliva collected with their SNDA-1000 saliva collection device. “This incredible innovation additionally delivered the first FDA EUA authorization for at-home biosample collection and provides 100 percent in-device viral inactivation.”

The SDNA-1000 saliva collection device creates the most robust and safest biomaterial collection approach for the detection of COVID infections and leads the way to a new era of at-home biosample self-collection for the diagnosis of many viral infections, mitigating any risk of infection throughout the testing process, delivering over a 90 percent reduction in PPE usage compared to swabbing, saving both time and money.

Spectrum Solutions Manufactures FDA EUA Authorized SDNA-1000 Saliva Collection Kit for Coronavirus Diagnostic Testing

Spectrum Solutions Manufactures Only FDA Authorized Saliva Collection Device for COVID-19 Testing Integration | Draper, Utah. (Photo by George Frey/Getty Images)

Utah Hustle

In addition to testing, Nelson Labs, LLC, located in Taylorsville, is one of a handful of laboratories authorized to certify masks and personal protective equipment.

According to company president, Jeffery R. Nelson, Nelson Labs tests virtually everything that can be found in the healthcare setting that could go in someone, on them, or around them to ensure it’s safe for healthcare providers and patients alike. The company helps ensure devices are biocompatible, clean or sterile, have safe packaging, and when needed, can be cleaned or reused. They also test face masks, respirators, and other protective equipment to make sure they function safely and adhere to industry standards.

Like BioFire, Nelson Labs’ high demand for personal protective equipment has been outpacing what could be manufactured in the short run, Nelson explains. And shortages of PPE have left hospitals and healthcare facilities with few options but to reuse equipment that was never intended to be reused.

Nelson Labs, along with its sister companies, Sterigenics, and Nordion, joined with industry leaders and government agencies to find ways for decontamination and sterilization of single-use PPE so it could be reused. As a result of the collaboration, Nelson Labs created a test plan that gives innovators trying to reprocess their PPE a way to validate their reprocessing solutions.

“This potentially allows many face masks, which were previously single-use, to be reprocessed and reused, increasing the total number of protective masks available to end-users,” Nelson says.

Kelvyn Cullimore, CEO of BioUtah also mentions that Utah companies like Sports Medicine Research and Testing Lab performs COVID testing for professional sports programs, including the National Football League, and the Major League Baseball, and Professional Golf Associations.

“When we think about the many challenges around the world created by this pandemic, we are honored to be playing an important role in supporting our customers in this fight against the coronavirus with the ongoing validation of PPE and other critical healthcare supplies,” says Cullimore.

Utah Hustle

In addition to testing, Nelson Labs, LLC, located in Taylorsville, is one of a handful of laboratories authorized to certify masks and personal protective equipment.

According to company president, Jeffery R. Nelson, Nelson Labs tests virtually everything that can be found in the healthcare setting that could go in someone, on them, or around them to ensure it’s safe for healthcare providers and patients alike. The company helps ensure devices are biocompatible, clean or sterile, have safe packaging, and when needed, can be cleaned or reused. They also test face masks, respirators, and other protective equipment to make sure they function safely and adhere to industry standards.

Like BioFire, Nelson Labs’ high demand for personal protective equipment has been outpacing what could be manufactured in the short run, Nelson explains. And shortages of PPE have left hospitals and healthcare facilities with few options but to reuse equipment that was never intended to be reused.

Nelson Labs, along with its sister companies, Sterigenics, and Nordion, joined with industry leaders and government agencies to find ways for decontamination and sterilization of single-use PPE so it could be reused. As a result of the collaboration, Nelson Labs created a test plan that gives innovators trying to reprocess their PPE a way to validate their reprocessing solutions.

“This potentially allows many face masks, which were previously single-use, to be reprocessed and reused, increasing the total number of protective masks available to end-users,” Nelson says.

Kelvyn Cullimore, CEO of BioUtah also mentions that Utah companies like Sports Medicine Research and Testing Lab performs COVID testing for professional sports programs, including the National Football League, and the Major League Baseball, and Professional Golf Associations.

“When we think about the many challenges around the world created by this pandemic, we are honored to be playing an important role in supporting our customers in this fight against the coronavirus with the ongoing validation of PPE and other critical healthcare supplies,” says Cullimore.

Utah Business-Utah’s biotech companies changed the course of the pandemic

Read the full article at UtahBusiness.com

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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.

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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
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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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