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Canary's 25-Second, 98% Sensitivity, Digital COVID-19 Saliva Test Achieves CE Mark

15 Marzo 2021

- Non-invasive ultra-rapid test delivers 98% sensitivity and 100% specificity in symptomatic and asymptomatic individuals with SARS-CoV-2 including variants

- Designed for point-of-care (POC) diagnosis, ease of use and rapid mass-screening, the digital platform enables efficient track & trace and has potential to open up the economy

NEW YORK, March 15, 2021 /PRNewswire/ -- Med tech company Pelican Diagnostics, a Canary Global Inc. company has received CE Mark for a 25-second COVID-19 saliva test, delivering real-time results with 98% sensitivity and 100% specificity. The Pelican COVID-19 Ultra-Rapid Mobile Test for the detection of SARS-CoV-2 is now cleared for sale and distribution in the European Union (EU). The test is also under review at the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA) for Over-the-Counter (OTC), non-prescription use and as a self-test.

The testing kit consists of a handheld reusable digital reader and disposable testing cartridges with direct detection technology to analyze multiple targets – spike (S) and nucleocapsid (N) proteins in saliva - to detect SARS-CoV-2. With a limit of detection of 1fg /ml, it correlates well with RT-PCR reference assay, the current gold standard. Taking less than 2 minutes for the entire testing process, the digital antigen saliva test has high sensitivity in both symptomatic and asymptomatic users, including detection of the known new variants. The POC test detects the virus without the need for lab equipment or amplification processes.

"Combining the power of nanosensor and digital detection technology, the Pelican CV19 test is the first point of care test that can return an accurate result with a 98% sensitivity and 100% specificity in less than 2 minutes" said Raj Reddy, President and CEO of Canary Global Inc. "The challenge with current rapid tests is that too often results are delivered after transmission already has begun. The more sensitive PCR tests take too long and are not suitable as point of care tests. Together with vaccine rollout, rapid, accurate and frequent testing on a connected platform to improve contact tracing is what is needed to stop the pandemic. This is what Pelican can provide."

Using cutting-edge nano-sensing technology in viral detection in saliva, the Pelican test has overhauled the need for invasive nasal sampling, previously thought to be the best way to detect the virus. Recent studies have indicated that using saliva can be an accurate detection method and can provide more information on the virus than a nasal swab test.i Most conventional rapid antigen tests which takes up to 30 minutes for a result suffer from accuracy challenges, particularly in asymptomatic individuals as demonstrated in a recent CDC studyii.

"The ability to detect SARS-CoV-2 early, before the onset of symptoms or those who never develop symptoms will help reduce household and community transmission, and enable fast clinical decisions for patient triage and care," added Reddy, "The potential for its use to safely open businesses, schools and event venues is a game-changer."

The device can also be wirelessly connected to a smartphone-based app for automated reporting. A result of "positive" or "negative" is given on the screen of the reader with more information for the patient on the connected mobile app. 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. The cloud-based testing system is HIPAA compliant which protects the integrity of protected health information of users.

www.pelicandetect.com/

Unleashing the Power of Smart Sensors & Deep Learning for Early Disease Detection

Contact:  Anna WangSVP, Corporate Affairsanna@canarydetect.com

i https://www.medrxiv.org/content/10.1101/2021.01.04.21249236v1 ii https://www.cdc.gov/mmwr/volumes/70/wr/mm7003e3.htm

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