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Rutgers Clinical Genomics Laboratory Receives FDA Approval to Add Direct-to-Patient at-Home Self-Collection Saliva Kits for COVID-19 Testing Exclusively Using Spectrum Solutions™ Saliva Collection Device

05/11/2020 | 06:02am EDT

Spectrum’s patented saliva preservation chemistry successfully demonstrated its unique ability to protect COVID-19 transcripts for extended periods making at-home sample collection and transport to Clinical Laboratory Improvement Amendments (CLIA) testing labs a reality.

Spectrum Solutions today announced the U.S. Food and Drug Administration (FDA) expanded the existing EUA200090 awarded to the Rutgers Clinical Genomics Laboratory to now include the at-home collection of saliva samples for COVID-19 testing. The basis for extending the device’s scope of approval was to include delivery of Spectrum’s SDNA-1000 saliva collection device direct-to-patients at home for self-collection of saliva testing samples. The FDA’s expanded scope of approval focused on the SDNA-1000 and its proven RNA preservation ability as well as the patient ease-of-use. This marks the first, and currently only, authorization by the FDA approving doctor prescribed COVID-19 testing allowing at-home saliva collection.

This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20200511005357/en/

Spectrum Solutions Saliva Collection Kit for COVID-19 Testing (Photo: Business Wire)

Spectrum Solutions Saliva Collection Kit for COVID-19 Testing (Photo: Business Wire)

“The FDA recognized that current methods of obtaining biosamples for COVID-19 testing were limiting in scope and scale due to supply shortages and the current testing methods were also constantly putting healthcare workers at risk of exposure. We’ve developed a better, more innovative solution,” said Stephen Fanning, CEO at Spectrum Solutions. “We are excited to announce that after extensive safety testing and validation, the FDA has additionally granted the SDNA-1000 approval for prescribed use in at-home testing for COVID-19. This new exclusive approval for direct-to-patient delivery using the SDNA-1000 saliva collection kit brings immediate relief to healthcare facilities while expanding their ability to easily test and help more people in the comfort and safety of their home.”

“Spectrum engineered its SDNA-1000 saliva collection device to eliminate common user collection errors in a universally intuitive, 3-step process which provides visual confirmation when successfully completed,” said Jeremy Johnson, research and development engineer at Spectrum Solutions. “We not only engineered this device to make self-collection intuitive, we also added a preservation chemistry that has proven itself to be the catalyst needed to deliver to labs the quality samples required for accurate COVID-19 detection.”

How It Works

  1. Individuals looking to purchase this EUA approved saliva-based at home COVID-19 test should contact their doctor to order or visit spectrumsolution.com/COVID19-at-home for an approved seller list.
  2. Patient arranges an appointment with a physician, which could be in person at the doctor’s office or via a telemedicine session.
  3. If physician determines the patient is a candidate for a COVID-19 test, the physician will prescribe the test and arrange for the test to be delivered to the patient.
  4. The patient will follow the simple saliva collection instructions in the kit on how to supply their saliva sample and how to return the sample to the processing lab through direct mail or drop off service.
  5. The lab will run the sample and report the results to the physician. The physician will then go over the results with the patient and determine the next course of action.

ABOUT SPECTRUM SOLUTIONS AND SPECTRUM DNA

Headquartered in Salt Lake City, Utah, Spectrum Solutions and its medical device and services division, Spectrum DNA, focus on innovative, end-to-end product development, manufacturing, and global fulfillment solutions. With concentrated industry expertise, Spectrum DNA specializes in engineering innovative molecular diagnostic solutions that simplify the biosample collection process while offering donors complete physical and digital chain-of-custody. With on-site production facilities, we are a single-source provider of full-service medical device manufacturing, custom and private label packaging, kitting, and direct-to-donor global fulfillment. Our new biosample collection devices, patented technology, and services provide measurable process optimization, unprecedented efficiency, and unmatched global scalability. For more information, please visit www.spectrum-dna.com.


ę Business Wire 2020
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