World’s First Saliva PCR SARS-CoV-2 Test for Point of Care Will Protect Workspaces for Public Employees
Charlottesville, VA – July 11, 2022- MicroGEM, a leading innovator of person-portable diagnostic devices and nucleic acid extraction products, has partnered with Government Scientific Source (GSS), a small business distributor of laboratory supplies to the U.S. government, to bring fast saliva PCR COVID-19 testing to government entities.
MicroGEM, a Virginia-based life sciences and molecular diagnostics company, develops innovative point-of-need diagnostic devices based on its revolutionary 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.
“With over 30 years serving federal, state, and local governments as a leading supplier of laboratory products, Government Scientific Source is the perfect partner to bring MicroGEM’s Sal6830 Point of Care PCR System to these critical clients,” said Geoffrey Stein, Director of Channel Partner Sales for MicroGEM. “Sal6830 uses on-the-spot RT-PCR to quickly detect intact virus using easy-to-collect saliva samples, allowing fast decision-making about a person’s possible infectiousness. It’s a first-of-its-kind option for government entities to keep their doors open while quickly and comfortably protecting their staff and visitors.”
With facilities in California, New Mexico, Tennessee, and Virginia, GSS works with a broad range of government procurement platforms including the Department of Energy’s Integrated Contractor Purchasing Team (ICPT) and Supply Chain Management Center (SCMC) agreements, the Defense Logistics Agency’s Electronic Cataloging (E-Cat), the Army Medical Logistics Command’s Medical Materiel Development Activity (USAMMDA), and the Department of Health and Human Services’ Intramalls. The company has key contracts with various states, health agencies, and U.S. federal departments, including the Department of Defense and the Department of Energy.
“GSS looks forward to partnering with MicroGEM to bring this innovative technology to our federal, state, and local government customers,” said Megan Devine, PhD, Life Science Category Manager at GSS. “The Sal6830 Point of Care System and its test cartridges will be made available on our GSA contract to further streamline federal purchasing needs.”
The MicroGEM Sal6830 SARS-CoV-2 Saliva Test has not been FDA cleared or approved but has been authorized for emergency use by the 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. The MicroGEM Sal6830 SARS-CoV-2 Saliva test is also authorized for laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate, or waived complexity tests.
For more information about how MicroGEM and Government Scientific Source are providing fast, accurate PCR testing at the point of care, visit https://www.govsci.com/product-detail/MICROGEM–US–INC–/SCFMA/EA/.