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1312, 2021

SDNA-1000 Saliva Collection Kit used to Track Variants and Successfully Detects Omicron

By Bryant|2023-12-15T04:36:50+00:00December 13th, 2021|Categories: #partoftheSolution, Clinical Solutions, COVID-19, IVD Commercialization Solutions, NEWS|Tags: #partofthesolution, #spitMatters, Amplitude Solution, back in class COVID testing, BioHive, BioUtah, cancer research study, cancer testing, cancer testing innovation, cell-free circulating tumor, ctDNA, diagnosis, diagnostic cancer testing, DNA collection, Dr. Wong, early detection, healthcare, k-12 COVID Testing, k12 testing program, liquid biopsy, Little League International, lung cancer, Major League Baseball, MiLB, Minor League Baseball, MLB, Molecular Diagnostic Testing, non-small cell lung cancer, NSCLC, PCR tests, personalized medicine, precision medicine, Regulatory Compliance, risk assessment, saliva cancer testing, Saliva Collection, Saliva Collection Device, saliva diagnostic testing, saliva diagnostics, saliva test, Saliva vs. Swabs, Saliva-Based Next-Gen Sequencing, SARS, screening, Spectrum DNA, Spectrum Solutions, spit test, Thermo Fisher, UCLA, UCLA research study, UCLA School of Dentistry, usctDNA, Utah Life Sciences|Comments Off on SDNA-1000 Saliva Collection Kit used to Track Variants and Successfully Detects Omicron

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

2611, 2020

Is Spectrum’s SDNA-1000 device “the test”?

By Bryant|2022-08-25T21:33:13+00:00November 26th, 2020|Categories: (1) SDNA-1000 Device, (2) Testing & Results|0 Comments

This is often misunderstood by test users. Our device is one element of the testing process. We are not a test by itself. Spectrum Solutions is the medical device manufacturer of the SpectrumDNA (SDNA) saliva collection system. A system

911, 2020

Can the SDNA-1000 be used for test pooling?

By Bryant|2022-05-31T21:21:10+00:00November 9th, 2020|Categories: (2) Testing & Results|0 Comments

Yes. If you have questions please reach out to your Spectrum contact or visit our contact us page.

911, 2020

How do I find a Lab in my area to set-up saliva-based diagnostic test processing using the SDNA-1000?

By Bryant|2022-05-31T21:13:38+00:00November 9th, 2020|Categories: (2) Testing & Results|0 Comments

Now that our SDNA-1000 saliva collection kit has its own device EUA authorization from the FDA, any lab currently EUA authorized for COVID-19 diagnostic testing can now simply integrate saliva collected with our system and start testing immediately. This

911, 2020

Why does the top of the SDNA-1000 collection kit say it isn’t for use in diagnostic procedures/for research use only?

By Bryant|2022-05-31T21:09:01+00:00November 9th, 2020|Categories: (1) SDNA-1000 Device|0 Comments

This is required language by the FDA. Outside of any "state of emergency", in normal testing scenarios, there are generally 2 main types of tests done. You have diagnostic testing and then you have everything else. Items in that

810, 2020

Spectrum Solutions Receives First Device FDA EUA Authorization for SDNA-1000 Saliva Collection System

By Bryant|2022-06-10T20:34:38+00:00October 8th, 2020|Categories: Clinical Solutions, COVID-19, NEWS, Product Innovations|Tags: at-home test, COVID-19 Testing, DNA collection, EUA Authorized, FDA Authorized, healthcare, Molecular Diagnostics, Product Innovations COVID-19, Regulatory Compliance, Saliva Collection, Saliva Collection Device, saliva test, Saliva vs. Swabs, SARS, Spectrum DNA, Spectrum Solutions, spit test, Viral RNA, viral RNA preservation|Comments Off on Spectrum Solutions Receives First Device FDA EUA Authorization for SDNA-1000 Saliva Collection System

FIRST EUA AUTHORIZED IVD DEVICE FOR SALIVA-BASED COVID-19 TESTING Spectrum Solutions Secures Emergency Use Authorization (EUA) for SDNA-1000 Leslie Titus Bryant October 08, 2020 New EUA Expanding Access and COVID-19 Testing Options On October 8th,

2305, 2020

Breakthrough Discovery: SDNA-1000 Post-Collection Saliva Sample Transport Stability

By Bryant|2022-08-25T21:31:41+00:00May 23rd, 2020|Categories: Solution Case Studies, Solution White Papers|Tags: at-home testing, COVID-19 Testing, DNA collection, EUA Authorized, FDA Authorized, healthcare, Molecular Diagnostics, Product Innovations COVID-19, Regulatory Compliance, Saliva Collection, Saliva Collection Device, saliva test, Saliva vs. Swabs, SARS, Spectrum DNA, Spectrum Solutions, spit test, Viral RNA, viral RNA preservation|Comments Off on Breakthrough Discovery: SDNA-1000 Post-Collection Saliva Sample Transport Stability

THE NEW YORK TIMES Just Spit and Wait- New Coronavirus Test Offers Advantage Saliva Transport Stability: Saliva has not only been demonstrated to be a robust source of viral RNA but when preserved with

1405, 2020

PRESS RELEASE: FDA Expands Saliva Testing for COVID-19 Including at-Home Self-Collection Exclusively Using Spectrum’s SDNA-1000 Kits

By Bryant|2022-08-25T21:39:22+00:00May 14th, 2020|Categories: Clinical Solutions, COVID-19, Medical Device Manufacturing, NEWS, Product Innovations, Solution Case Studies|Tags: at-home testing, COVID-19 Testing, DNA collection, EUA Authorized, FDA Authorized, healthcare, Molecular Diagnostics, Product Innovations COVID-19, Regulatory Compliance, Saliva Collection, Saliva Collection Device, Saliva vs. Swabs, SARS, Spectrum DNA, Spectrum Solutions, Viral RNA, viral RNA preservation|Comments Off on PRESS RELEASE: FDA Expands Saliva Testing for COVID-19 Including at-Home Self-Collection Exclusively Using Spectrum’s SDNA-1000 Kits

PRESS RELEASE SLC: THE NEW YORK TIMES: Just Spit and Wait - New Coronavirus Test Offers Advantage Expanded Authorization for at-home saliva collection granted exclusively using Spectrum's SDNA-1000 Leslie Titus Bryant Spectrum Solutions Corporate Spokesperson,

905, 2020

What does a device EUA Authorization mean for the SDNA-1000?

By Bryant|2022-05-31T21:08:47+00:00May 9th, 2020|Categories: (1) SDNA-1000 Device|0 Comments

On February 4, 2020, pursuant to Section 564(b)(1)(C) of the Act, the Secretary of the Department of Health and Human Services (HHS) determined that there is a public health emergency that has a significant potential to affect national security

1304, 2020

FDA EUA200090 Granted Exclusively Using SDNA-1000 for Saliva COVID-19 Testing

By Bryant|2021-04-29T18:52:34+00:00April 13th, 2020|Categories: Clinical Solutions, COVID-19, NEWS, Product Innovations, Solution Case Studies|Tags: at-home testing, COVID-19, COVID-19 Testing, EUA Authorized, healthcare, Molecular Diagnostics, Saliva Collection, Saliva Collection Device, Saliva vs. Swabs, SARS, Spectrum DNA, Spectrum Solutions, Viral RNA, viral RNA preservation|Comments Off on FDA EUA200090 Granted Exclusively Using SDNA-1000 for Saliva COVID-19 Testing

PRESS RELEASE FDA Emergency Use Authorization Granted Utilizing Saliva for COVID-19 Testing Exclusively Using SDNA-1000 Saliva Collection Device From Spectrum Solutions EUA200090 states, “Saliva specimens must be collected, transported and stored using the Spectrum Solutions

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