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Source: COVID-19 Diagnostics  May 09, 2020  3 years ago
COVID-19 Diagnostics: US FDA Grants Approval To First COVID-19 Home Saliva Test
COVID-19 Diagnostics: US FDA Grants Approval To First COVID-19 Home Saliva Test
Source: COVID-19 Diagnostics  May 09, 2020  3 years ago
COVID-19 Diagnostics: Biotech Firm, Rutgers' RUCDR Infinite Biologics received an amended emergency use authorization from the US FDA for the first SARS-CoV-2 coronavirus/COVID-19  test that will allow individuals to collect their own saliva in the comfort of their  homes and send to a lab for testing and results, without risking any exposure in crowded healthcare settings.

The newly approved at-home saliva self-collection assay, developed by RUCDR in partnership with Spectrum Solutions and Accurate Diagnostic Labs, allows for broader screening than through the standard method using nose and throat swabs at a healthcare facility or testing location that requires a physical interaction with a healthcare professional.
Dr Andrew Brooks, CEO and director of technology development at RUCDR, who also is a Professor in the School of Arts and Sciences Department of Genetics at Rutgers University-New Brunswick said, "The implications of this approval means that not only do we no longer have to put healthcare professionals at risk for infection by performing nasopharyngeal or oropharyngeal collections, we can now preserve precious PPE for use in patient care instead of testing and can significantly increase the number of people collected each and every day in places other than a healthcare setting."
He added, "This will enable testing for individuals that do not have the means to get to a collection center and/or are at home because they are sick, quarantined, at increased risk for infection or simply concerned about exposing themselves by traveling to a collection site. This approach will have a significant impact on helping people in New Jersey and across the America get back to work as we will be able to monitor large numbers of individuals in a variety of locations.”
Dr Brooks further added, "Collecting a saliva sample at home mitigates the risk of exposure needed to travel to a facility or drive through and is less invasive and more comfortable and reliable than sticking a swab up one’s nose or down one’s throat. Protecting both patients and healthcare professionals from any unnecessary exposure is of paramount importance and saliva home collection addresses almost all issues around testing quality, safety and availability."
The US FDA emergency use authorization is the second obtained by RUCDR Infinite Biologics and its collaborators in recent weeks. The first was for a new collection approach that uses saliva as the primary test biomaterial for the SARS-CoV-2 coronavirus, which was the first such approval granted by the FDA and allowed health care workers to collect people's saliva at testing sites.

This fully automated nucleic acid extraction workstation at Rutgers' RUCDR
Infinite Biologics can process up to 10,000 saliva samples per day for 
SARS-CoV-2 coronavirus testing. Credit: David Sokolowsk
Last month, RUCDR also launched a genetic testing service for the coronavirus that can test thousands of samples daily. With the new saliva tests and expanded collection strategy, that number can increase to tens of thousands of samples daily.
Rutgers-New Brunswick University Chancellor Chris Molloy commented, "RUCDR Infinite Biologics' pioneering research exemplifies Rutgers' commitment to addressing the most pressing global challenge we face. By significantly increasing the number of people who can be tested every day, we are helping combat this pandemic and providing a way to move our communities forward. We are proud that Rutgers can be on the cutting edge of this achievement."
Dr Brooks also added, "Saliva testing addresses many critical issues associated with large-scale screening that is required to get people back to their normal daily lives. Saliva testing is very important for symptomatic patients at home, so they can better determine how long it will be until they are no longer infectious and can safely return to their daily activities. Significantly, this new approval will help the Rutgers community directly by allowing for convenient and precision testing of faculty, students and staff when the time comes for Rutgers to reopen the campus."
The university and its commercial arm and also partners are planning to scale up production not only for domestic use but also for exports to other countries needing such test kits and services.
For the latest developments with regards to COVID-19 diagnostics, keep logging to Thailand Medical News.
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