New York (January 18, 2021) – Med tech company Canary Global has received CE Mark for its DigiGENE™ COVID-19 Rapid Molecular Test Kit, a self-collected, PCR-like accuracy, multi-use, rapid point of care (POC) molecular diagnostic test for COVID-19. The saliva-based test produces a positive result in as little as 5 minutes, or a negative result in less than 20 minutes. The window of detection for the Omicron variant can be as early as 2 days after exposure. An immediate verified test result is sent to the individual’s mobile device. A HIPPA-compliant result can also be sent to public health authorities for contact tracing and surveillance purposes. This product is under research and development and not for commercial sale.
The DigiGENE™ COVID-19 Rapid Molecular Test Kit is now cleared for sale and distribution in the European Union (EU). The kit is able to process 4 test samples at the same time, making it highly suitable where quick and accurate results for a large number of people are required such as at schools, airports, event venues, borders and businesses. The test kit is also being prepared for review with the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA) for both home-use as well as POC test in healthcare or business settings.
The testing kit consists of a handheld reusable digital reader and disposable testing cartridges with digital detection technology to analyze multiple targets to detect SARS-CoV-2. This “lab on a chip” technology combines the use of loop-mediated isothermal amplification (LAMP) and smart sensors and cloud-based analytics. With a limit of detection of 600 copies of viral RNA per mL, this molecular test is on par with most lab-based PCR tests, the current gold standard. The hand-held POC test detects the virus without the need for lab equipment or professional operators.
He added, “The challenge with current rapid tests and molecular tests is that too often results are delivered after transmission already has begun. The antigen tests are not sensitive enough while the PCR tests take too long to return a result. Now with the possibility of COVID treatments, accurate testing that can return an immediate result is even more critical. Vaccine rollout, effective treatments and frequent testing is what is needed to stop the pandemic. This is what Canary’s DigiGENE™ technology can provide.”
Using next-generation nano-sensing technology in RNA detection of the virus in saliva, oral and nasal passages, Canary has developed the most sensitive rapid molecular test with real-time reporting capabilities. Recent studies have indicated that using saliva as test samples can provide more information on the virus and detect the virus a day earlier than the current method of the more invasive nose swabs.[i]
“The ability to detect SARS-CoV-2 early, before the onset of symptoms, or those who never develop symptoms, will help drastically reduce household and community transmission. And in the face of therapies that are currently be developed, a faster diagnosis will make all the difference in controlling and stopping the spread of COVID.” added Reddy, “The potential for its use to safely open businesses, schools and event venues is a game-changer. We plan to gear up production to supply the point of care market with millions of units over the coming months.”
The device is also designed to be wirelessly connected to a smartphone-based app for automated reporting. Each disposable test cartridge contains multiple sensors and a unique QR code which is linked to the user’s cell phone or another connected device where the result is sent in real-time. The cloud-based testing system is HIPAA compliant which protects the integrity of protected health information of users.
Unleashing the Power of Smart Sensors & Deep Learning for Early Disease Detection
Contact: Anna Wang
SVP, Corporate Affairs