MicroGEM, a U.S.-based molecular biology company, announced that Medline, a manufacturer and distributor of medical supplies to healthcare providers across the continuum of care, is now offering the MicroGEM Sal6830 Point of Care PCR System and SARS-CoV-2 Saliva Test.
The partnership comes as the nation continues to average more than 100,000 new cases and nearly 500 COVID-related deaths a day, with new cases and hospitalizations driven by the Omicron BA.5 variant, according to the Centers for Disease Control and Prevention (CDC).
“Sal6830 is transforming the ‘new normal’ of living and working with COVID-19 by providing an easy, convenient saliva test that eliminates the discomfort of nasal swabs,” says Geoff Stein, director of channel partner sales for MicroGEM. “Medline is a terrific choice as a partner, joining us in sharing the message that ‘sticks up the nose’ can be a thing of the past, and providing their deep and proven technical knowledge, support, and flexibility to quickly respond to customer needs and demands.”
The Sal6830 leverages MicroGEM’s proprietary point of care technology, which combines enriched intact virus, thermophilic enzymatic RNA extraction, and microscale high-speed RT-PCR to capture whole virus to detect SARS-CoV-2 in under 30 minutes. Sal6830’s non-invasive saliva sampling, simple on-screen instructions, fast on-the-spot results, and portability provide an invaluable tool to quickly and accurately detect COVID-19 in settings ranging from healthcare centers, film production sets, and government and academic facilities, to mobile testing sites, retirement homes and long-term care communities.
Medline will introduce the Sal6830 to healthcare organizations and vulnerable communities, such as assisted living facilities, that have existing and emerging needs to quickly test and protect their staff, visitors, residents, and patients.
“It is important that we continue to look at new ways to help customers drive efficiency around the ebb and flow of COVID-19 testing,” says Nicole Krpan, vice president of Medline’s laboratory division. “Our partnership with MicroGEM expands our product portfolio to offer a saliva-based test for the first time. We expect this to help expand our partnerships with lab leaders to optimize their performance.”
The Sal6830 SARS-CoV-2 Saliva Testing Kit’sinnovative cartridge design allows new targets to be added or replaced quickly, significantly reducing both assay and product development time. The company plans on seeking authorization to expand the test menu and ruggedize the system to address austere field conditions presented in military and disaster medicine use cases, and adapt the system for the precision medicine healthcare market with quantitative gene expression panels used as biomarkers.
MicroGEM has established a U.S.-based supply chain, with R&D pilot manufacturing facilities in Charlottesville, Virginia, large-scale test kit production facilities in Ogden, Utah, and instrument production facilities in Hudson, New Hampshire.
The MicroGEM Sal6830 Point of Care PCR Systemand theMicroGEM Sal6830 SARS-CoV-2 Saliva Testrecently received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) and have been funded in part by the National Institutes of Health (NIH), Rapid Acceleration of Diagnostics (RADx) initiative to expedite the launch of the test with federal funds from the National Institute of Biomedical Imaging and Bioengineering, National Institutes of Health, Department of Health and Human Services, under Contract No. 75N92020C00015.
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 by authorized laboratories. This product has been authorized only for the detection of nucleic acid form SARS-CoV-2, not for any other viruses or pathogens. The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.