PRESS RELEASE:

RxBIO brings COVID-19 Spectrum Solution saliva collection kit with 99.998% accuracy to Canadians

RxBio
May 4 th, 2021

Spectrum Solutions’ system first to receive FDA emergency use authorization

TORONTO – A saliva collection kit that uses a pain-free method to test for COVID-19 is being distributed in Canada for the first time by RxBIO Corp., a leading medical device distribution company. Spectrum Solutions’ SDNA saliva collection kit offers a comfortable and more accurate alternative to the painful nasal swab test method for COVID-19.

Approved by Health Canada in January 2021, Spectrum’s SDNA saliva collection kit is the first saliva-based system to receive Emergency Use Authorization for COVID-19 testing by the U.S. Food and Drug Administration. The launch of Spectrum’s SDNA-2000 and SDNA-3000 Saliva Collection Devices in Canada means Canadians have access to an effective saliva-based COVID-19 test option, with 99.998 percent accuracy. The device is so reliable that Major League Baseball uses Spectrum’s SDNA-1000 saliva collection kits to test all players and staff.

“We are thrilled to partner with Spectrum Solutions to offer Canadians an alternative option at a time when testing for COVID-19 is at a crucial stage,” said Alfan Jetha, RxBIO’s CEO. “As the vaccination program rolls out across the country, daily testing is more important than ever to prevent viral spread and Spectrum Solutions is a leader in molecular diagnostic testing.”

Spectrum’s SDNA saliva collection device is a three-component kit that enables self-collection of saliva samples. The device has the ability to 100 percent inactivate the live virus at ambient temperatures, mitigating any risk of infection throughout the testing process. Samples are preserved for 10 days post-collection without any degradation of sample efficacy and do not require temperature-controlled storage or transport. The kits can be used in a variety of scenarios, including at-home testing by individuals or mass testing by organizations.

“Testing for COVID-19 should be accurate, efficient, and user-friendly – those are hallmarks of Spectrum Solutions’ saliva collection device,” said Jasmin Jetha, President and COO for RxBIO. “The saliva collection kit was also designed to minimize user collection errors.”

“At Spectrum, we engineered our revolutionary saliva-based PCR testing kits for early detection accuracy and safety. No trade-offs. After all, if you display symptoms, you have already exposed others to possible infection,” said Stephen Fanning, President and Chief Executive Officer for Spectrum Solutions. “Our highly sensitive formulation is able to detect infections from saliva samples measuring as low as 200 copies/ml with viral neutralization in contrast to lateral flow rapid antigen testing requiring a minimum of 10,000-20,000 copies/ml.

RxBIO is a Canadian biotech distribution company based out of Toronto and Dublin with expertise in providing medical devices and personal protective equipment to healthcare facilities and communities across Canada, the United States, the United Kingdom, and Europe. With its global infrastructure and extensive distribution channels, RxBIO connects healthcare professionals around the world with cutting-edge technology and innovative solutions.
RxBIO is part of an extensive portfolio of integrated healthcare companies involved in pharmacy, clinical trials, regulatory, healthcare distribution, and virtual care services.
Headquartered in Salt Lake City, Utah, Spectrum Solutions 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. Spectrum is a single-source provider of innovative medical device engineering and product manufacturing, molding, chemical formulation, packaging design, customized kitting, and direct-to-user fulfillment. Its bio-sample collection devices patented technologies, and dedicated services deliver measurable process optimization, unprecedented efficiency, and unmatched global scalability.

RXBIO BRINGS SPECTRUM SOLUTION SALIVA COLLECTION SYSTEM FOR COVID TESTING TO CANADA

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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

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Slide Predict, Diagnose, & Prevent Saliva-Based Diagnostic Solutions #SpitMatters blank

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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