Effort expands access to the world's first saliva PCR SARS-CoV-2 test
for use at point of care
Charlottesville, VA, July 5, 2022 — MicroGEM, an innovator of person-portable diagnostic devices and nucleic acid extraction products, announced today that is partnering with Songbird Life Science, a leading distributor of point of care rapid testing solutions, to bring fast saliva PCR COVID-19 testing to industries ranging from manufacturing and mining to sports competitions — wherever physical distancing may not be possible or access to PCR testing is limited.
MicroGEM, a Virginia-based life sciences and molecular diagnostics company, develops innovative point-of-need diagnostic devices based on its evolutionary approach to sample preparation. The company recently received Emergency Use Authorization from the FDA for the MicroGEM Sal6830 SARS-CoV-2 Saliva Test, the world’s first saliva PCR test to detect SARS-COV-2 at the point of care in under 30 minutes.
“Songbird’s dedication to providing their clients with solutions and strategies that guarantee uninterrupted operations aligns with the unique capabilities of the MicroGEM Sal6830 Point of Care PCR System,” said Geoffrey Stein, Director of Channel Partner Sales for MicroGEM. “Sal6830 is the first FDA-authorized testing platform that provides fast, simple, on-the-spot saliva PCR testing to detect SARS-CoV-2 at the point of care. It is a valuable testing tool for use in both congregate work settings where operations depend on safe, healthy employees and in remote locations where waiting hours or days for COVID-19 results is not tenable.”
Songbird Life Science provides an unmatched understanding of pathogens, ventilation, air quality, and industry operations. It brings together world-class experts in DNA-molecular biology and building science to ensure operations run uninterrupted and people feel safe within shared spaces where social distancing is not realistic.
“The Songbird Life Science team is thrilled to be partnering with MicroGEM as part of its U.S. launch of Sal6830,” said John Andonoff, General Manager at Songbird. “Songbird focuses on identifying novel solutions that help create safe, shared work environments. The innovative Sal6830 will enable more US businesses to protect their employees, allowing for businesses to remain up and running at this critically important time. Combining MicroGEM’s ingenuity with Songbird’s expertise in creating safe workspaces results in a powerful collaboration.”
The MicroGEM Sal6830 SARS-CoV-2 Saliva Test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA for use at the point of care in patient settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation. MicroGEM is seeking full FDA approval.
For more information about how MicroGEM and Songbird Life Science are providing fast, accurate saliva PCR testing for SARS-CoV-2 in industrial workspaces, visit https://songbirdlifescience.com/rapid-testing/pcr/sal6830/.
About Songbird Life Science
Songbird Life Science offers science-based, point-of-care rapid testing solutions to keep people and places safe from COVID-19. The joint venture between RWDI, leading engineers in building science, and Purity-IQ, world-renowned genomic and biotechnology scientists, Songbird provides an unmatched understanding of pathogen transmission within shared spaces. The first company in Canada to offer point-of-care PCR rapid testing during the height of the pandemic, Songbird remains committed to sourcing only top-quality, FDA and Health Canada-authorized technology.
MicroGEM is democratizing molecular diagnostics by moving molecular techniques out of conventional, highly skilled laboratories to non-laboratory settings. The company’s innovative enzymatic approach to nucleic acid extraction provides the foundation for efficient sample preparation suitable for PCR analysis. Recently awarded over $50 million by the National Institutes of Health, Rapid Acceleration of Diagnostics (RADx) initiative, MicroGEM has leveraged its RNA extraction capabilities to develop the MicroGEM Sal6830 Point of Care PCR System and SARS-CoV-2 Saliva Test, representing the next generation of point-of-need solutions for the management of infectious diseases and other personalized medicine applications.