The EUA status enables the immediate use of saliva in COVID-19 testing exclusively applying the Spectrum SDNA-1000 saliva collection device
The FDA EUA approval allows the immediate use of saliva in COVID-19 testing using the Spectrum SDNA-1000 saliva collection device. (Credit: Business Wire)
The US Food and Drug Administration (FDA) has granted emergency use authorisation (EUA) for saliva-based COVID-19 test.
The EUA status allows the immediate use of saliva in COVID-19 testing exclusively applying the Spectrum SDNA-1000 saliva collection device, which enables to protect and preserve RNA used to detect infection.
Spectrum Solutions CEO Stephen Fanning said: “Using saliva to test for COVID-19 overcomes many of the challenges the nation faces that are inherent to current testing methods including supply shortages and risks to exposure for healthcare professionals.”
Rutgers’ RUCDR Infinite Biologics has worked closely with Spectrum Solutions and Accurate Diagnostic Labs (ADL) to develop the new saliva collection method that is believed to screen broader population than the current method of nose and throat swabs.
The EUA status was based on the data of saliva versus swab study, which uncovered a testing alternative using saliva collected with Spectrum’s SDNA-1000 saliva collection device.
The results helped to fast-track the EUA approval for RUCDR Infinite Biologics – Rutgers Clinical Genomics Laboratory and its Perkin Elmer nucleic acid extraction and ThermoFisher TaqPath SARS-CoV-2 automated processes using the Spectrum SDNA-1000 device.
The new test will facilitate self-administered sample collection by individuals who are in quarantine or self-isolation
In addition, the new test will facilitate self-administered sample collection by individuals who may be in quarantine or self-isolation, enabling to reduce exposure to healthcare professionals and patients.
Recently, RUCDR has also announced the launch of genetic testing service for the coronavirus, which can test thousands of samples per day.
RUCDR Infinite Biologics chief operating officer Dr Andrew Brooks said: “The Spectrum Solutions SDNA-1000 Saliva Collection Device was chosen to collect, transport and store saliva specimens for the TaqPath SARS-CoV-2 Assay proof-point study given RUCDR’s experience with Spectrum products across a wide range of applications currently employed.”
Separately, the FDA has granted an emergency use authorisation (EUA) for a blood purification system to treat COVID-19 disease.