Health Canada Authorizes Precision Biomonitoring to Import and Sell Biomeme's SARS-CoV-2 Real-Time RT-PCR Test in Response to COVID-19

Ultra-portable testing solution approved for use across Canada

GUELPH, ON and PHILADELPHIA, July 7, 2020 /CNW/ - Biomeme and Precision Biomonitoring, industry leaders in rapid DNA field detection, announce that Health Canada has approved Biomeme's SARS-CoV-2 Real-Time RT-PCR Test and rapid mobile detection platform for immediate deployment across Canada by Precision Biomonitoring. Approval was based on lab validation data generated through stringent testing of viral samples in performance areas including sensitivity and specificity. The approval is aligned with the Government of Canada's ongoing commitment to collaborate with innovative companies dedicating their efforts to combating the pandemic.

"This approval is the result of the dedication and commitment of our teams at Precision Biomonitoring and Biomeme, as well as ongoing collaboration with our validation partners," says Dr. Mario Thomas, CEO of Precision Biomonitoring. "This rapid test can now be distributed everywhere across Canada, especially in remote areas and workplaces where creating virus-free zones is vital. We can now bring the lab to the sample."

More About the Biomeme Device & Software

Weighing only 1.2 kg, battery-operated and able to deliver results for up to nine samples in about 60 minutes, the mobile device and its easy-to-use software are ideal for all locations where screening is needed such as assessment centers, long-term care and nursing homes, retirement communities, ships, airports, borders and more distant regions. Precision Biomonitoring has also partnered with Guelph-based environmental consulting firm, Shared Value Solutions, to bring the approved rapid mobile testing platform to Indigenous communities in northern Ontario in response to COVID-19.

A free and intuitive smartphone mobile app pairs wirelessly with the device to easily run, monitor, and analyze the results of each test. Tests can be run online or offline, results can be interpreted in real-time, and all data can be securely synced to the cloud. Both the device and smartphone can be transported in a laptop-sized bag making it ideal for spot tests, especially when results are now needed in emergency rooms and more rural and remote regions.

More About the Test

The SARS-CoV-2 Real-Time RT-PCR Test requires no special lab equipment or cold chain and is intended for the qualitative detection of RNA from SARS-CoV-2 in nasopharyngeal and oropharyngeal (throat) swab samples. The assay's two RNA targets are multiplexed together with Biomeme's RNA extraction and RT-PCR process control in a single triple reaction. While being able to perform these tests in remote areas and workplaces is critical, the SARS-COV-2 test is also being manufactured in form factors suitable for high throughput labs. Here is a summary of each shelf-stable, pre-mixed form factor approved for use by health care providers across Canada:

• 3-Well Go-Strips^TM: Optimized for performance in the field. Each Go-Strip^TM has 3 reaction wells and each well contains a 20 µL lyophilized triplex reaction. With this form factor, there is no aliquoting or mixing of components in the field. You just add your sample to the strips and begin your test.
• 96-Well Go-Plates^TM: Optimized for high throughput lab use in standard commercial thermocyclers (Bio-Rad CFX96, ABI QuantStudio5). Just like above, each Go-Plate^TM is shelf-stable, pre-mixed, and pre-aliquoted with the same lyophilized triplex reaction.
• Bulk Vials: Optimized more for lab use in any thermocycler. Each vial is shelf-stable, pre-mixed and lyophilized, but they are not pre-aliquoted, so you are free to use your own plastics.

"Having a reliable rapid test is critical for controlling the spread of COVID-19, especially in certain communities or rural settings where testing may take longer. It will allow these communities to get results faster and will enable healthcare professionals to take the necessary steps to expedite their response to COVID-19 cases," said Dr. Rob Kozak, clinical microbiologist at Sunnybrook Health Sciences Centre.

The approval from Health Canada, combined with these capabilities and various form factors, allows Precision Biomonitoring to contribute to initiatives and programs recently implemented by the Government of Canada, as well as close to home in Ontario, where the government continues to focus on increasing testing capacity and creating safe workplaces.

To learn more about the different COVID-19 testing kits available, please visit pbidiagnostic.com. 

Third Party Clinical Evaluations

Northwell Health is New York State's largest healthcare employer, with more than 68,000 employees and home to 23 hospitals and more than 700 outpatient facilities, as well as urgent care centers, kidney dialysis centers, acute inpatient rehabilitation, sub-acute rehabilitation and skilled-nursing facilities, a home care network, a hospice network, and other services. Northwell completed a clinical evaluation of the Biomeme SARS-CoV-2 Real-Time RT-PCR Test with clinical nasopharyngeal and oropharyngeal samples with a range of Ct values. This evaluation utilized 65 samples tested with 4 comparator platforms: GenMark ePlex, Hologic Panther Fusion, Wadsworth/CDC and Roche Cobas 8800. It found a 98% correlation (64/65).

About Precision Biomonitoring 

Founded in 2016 by a team of scientists from the University of Guelph's Biodiversity Institute of Ontario, Precision Biomonitoring provides TripleLock™ onsite eDNA surveillance platform solutions that give customers earlier detection of organisms for a more rapid response. Customers are any organizations that need onsite surveillance and rapid identification of any organism in any environment. The Precision Biomonitoring team is at the forefront of technological innovations in the genomics industry. Our vision is a world where we can identify any organism on the spot, in an instant, anywhere on the planet. 

About Biomeme

Biomeme entered into molecular detection over 7 years ago when it created the first iPhone add-on capable of performing real-time PCR. Since its inception, Biomeme has used advanced biology and chemistry, along with world-class hardware and software engineering, to create elegant solutions to complex problems. Headquartered in Philadelphia, USA, Biomeme offers a full suite of end-to-end mobile molecular solutions. Biomeme's 1-minute sample prep, shelf-stable reagents, hand-held thermocycler, cloud portal, and web API perform to the gold standard used by the world's most advanced central labs but require no lab equipment or special experience to use.

SOURCE Precision Biomonitoring

Media Contact: Meredith Adams, 416-459-7086, [email protected]