Health Canada authorizes world's first saliva point-of-care PCR test to quickly detect Sars-Cov-2

MicroGEM US Inc., a U.S.-based molecular biology company, has announced that Health Canada has issued an Interim Order authorization for the Sal6830 SARS-CoV-2 Saliva Testing System, which provides polymerase chain reaction (PCR) results at the point of care in under 30 minutes.

The authorization comes as the nation braces for what health officials describe as the seventh wave of COVID-19, driven by the Omicron BA.5 subvariant.

“We are pleased that, with Health Canada’s action, the Sal6830 SARS-CoV-2 Saliva Testing System is now available to help strengthen COVID-19 testing with a fast and accurate on-site PCR option at this critical time,” said MicroGEM’s Ottawa-based Chief Commercial Officer, LeRoy Blake.

“The Sal6830 represents a transformative shift in testing for SARS-CoV-2. A saliva sample is much more comfortable to provide compared to an intrusive nasal swab, making it ideal for children, routine testing, and anyone who dislikes or is anxious about swabbing. Easy sample collection, combined with accurate PCR at the location where it is needed, ensures real-time decisions without delays sending samples to a lab. This is a critical advancement in testing capabilities, ensuring the availability of easy sampling and on-site PCR results to keep the economy open and protect workplaces and communities,” said Blake.

The Sal6830 SARS-CoV-2 Saliva Testing System is the first PCR saliva test authorized by Health Canada for SARS-CoV-2 for use at the point of care. Clinically evaluated during both the Delta and Omicron waves of the pandemic, the Sal6830 SARS-CoV-2 Saliva Testing System has proven to perform robustly throughout the viral mutations.

MicroGEM’s Sal6830 is designed to capture intact virus, a key indicator of infectiousness, and then implements a unique process of thermophilic enzymatic RNA extraction, adsorptive purification, and microscale high-speed RT-PCR to detect SARS-CoV-2. In April 2022, the Sal6830 received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), for deployment in a variety of U.S. locations including healthcare settings, film production sets, and government and academic facilities, mobile testing sites, and other businesses.

MicroGEM has a Canadian distribution agreement with Guelph, Ontario-based Songbird Life Science. A national leader in providing point-of-care rapid testing solutions in some of the most challenging and complex environments, Songbird offers an unmatched understanding of pathogen transmission within the built environment. Now, with the Sal6830 added to its range of authorized DNA/RNA-identification technologies, Songbird is deploying its science-based solutions to even more Canadian businesses and communities.

The Sal6830 SARS-CoV-2 Saliva Testing System is simple to operate with easy saliva collection, efficient workflow, and touchscreen instructions. Additional benefits include:

• Robust with existing variants: Clinically evaluated during both the Delta and Omicron waves, the multiple SARS-CoV-2 gene targets allow for robust detection of current variants and protect against obsolescence from future variants.
• Portable: The platform’s small size is easily incorporated at testing sites such as mobile testing labs, ambulatory surgical centers, emergency departments, workplaces, and gathering places.

The Sal6830 SARS-CoV-2 Saliva Testing Kit’s innovative cartridge design allows new targets to be added or replaced quickly, significantly reducing both assay and product development time. The company’s plans include seeking authorization to expand the test menu and ruggedize the system to address austere field conditions presented in military and disaster medicine use cases. Plans are also underway to adapt the system for the fast-growing precision medicine healthcare market with quantitative gene expression panels used as biomarkers.

MicroGEM has established a North American-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.

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