ABC NEWS:

WASHINGTON POST
HEALTH 202: The newest way to test for coronavirus: Spitting in a tube

Scientist behind saliva test breakthrough sees bridge to nationwide coronavirus screening

In a Rose Garden briefing, Tuesday President Donald Trump touted a potential new way of testing for the novel coronavirus could be safer for suspected coronavirus patients and health care workers and help alleviate the backlog in hard-hit cities — spit.

The Food and Drug Administration gave emergency authorization Friday for a testing method developed by a Rutgers University lab that, instead of relying on swabs that reach deep into the nasal cavity, is designed to check for evidence of the virus in a patient’s saliva.

“I call it innovation under pressure,” Trump said. “The tests can be self-administered by patients in health care settings, which will reduce exposure for medical workers and save personal protective equipment.”

Rutgers said the saliva tests are already being made available to the large New Jersey health care system RWJBarnabas and at a number of New Jersey hospitals and facilities. A drive-thru testing facility utilizing this new method is also planned this week in Edison, New Jersey.

Though the tests are only now ramping up, already several companies have begun working on manufacturing and selling versions of them, including the start-up Vault Health, a New York-based men’s health company.

“This is not an at-home test,” Hahn said of the government-authorized method. “This still has to be performed with a provider, but it does provide great advantages moving forward and expands the opportunities for testing.”

Abdelmalek said concerns about self-administered tests stem in part from the worry that the patient could make an error that leads to an incorrect outcome — and waste valuable testing resources in the process.

Spectrum Solutions Saliva Collection Kit COVID-19 Testing

© Spectrum Solutions™ | Photo Credit: Leslie Titus Bryant

Scientist behind saliva test breakthrough sees bridge to nationwide coronavirus screening

In a Rose Garden briefing, Tuesday President Donald Trump touted a potential new way of testing for the novel coronavirus could be safer for suspected coronavirus patients and health care workers and help alleviate the backlog in hard-hit cities — spit.

The Food and Drug Administration gave emergency authorization Friday for a testing method developed by a Rutgers University lab that, instead of relying on swabs that reach deep into the nasal cavity, is designed to check for evidence of the virus in a patient’s saliva.

“I call it innovation under pressure,” Trump said. “The tests can be self-administered by patients in health care settings, which will reduce exposure for medical workers and save personal protective equipment.”

Rutgers said the saliva tests are already being made available to the large New Jersey health care system RWJBarnabas and at a number of New Jersey hospitals and facilities. A drive-thru testing facility utilizing this new method is also planned this week in Edison, New Jersey.

Though the tests are only now ramping up, already several companies have begun working on manufacturing and selling versions of them, including the start-up Vault Health, a New York-based men’s health company.

“This is not an at-home test,” Hahn said of the government-authorized method. “This still has to be performed with a provider, but it does provide great advantages moving forward and expands the opportunities for testing.”

Abdelmalek said concerns about self-administered tests stem in part from the worry that the patient could make an error that leads to an incorrect outcome — and waste valuable testing resources in the process.

Spectrum Solutions Saliva Collection Kit COVID-19 Testing

© Spectrum Solutions™ | Photo Credit: Leslie Titus Bryant

ABC News- Trump touts saliva coronavirus tests after FDA emergency authorization

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Noninvasive
Saliva Diagnostics

This changes everything

Health is a dynamic state of well-being. Healthcare providers and researchers have long believed that changes in our saliva record our ongoing state-of-health story. 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
Questions, Let’s Connect!

Noninvasive
Saliva Diagnostics

This changes everything

Health is a dynamic state of well-being. Healthcare providers and researchers have long believed that changes in our saliva record our ongoing state-of-health story. 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
Questions, Let’s Connect!

Outside-of-the-Box Thinking, Inside-of-the-Box Clinical Innovation

Anywhere from customized testing solutions to new medical science product innovations–we’re here to help.

Outside-of-the-Box Thinking, Inside-of-the-Box Innovation

Anywhere from customized testing solutions to new medical science product innovations–we’re here to help.