Canary Health Technologies Submits a Revolutionary 25-Second, 98% Sensitivity, Digital COVID-19 Saliva Test to the FDA
CLEVELAND, Feb. 9, 2021 /PRNewswire/ -- Med tech company Canary Health Technologies, Inc. has developed a 25-second COVID-19 test, delivering real-time results with 98% sensitivity and 100% specificity. The test is being submitted to the U.S. Food and Drug Administration (FDA) under Emergency Use Authorization (EUA) for Over-the-Counter (OTC), non-prescription use for the detection of SARS-CoV-2. Suitable for self-testing, Canary's Pelican COVID-19 Ultra-Rapid Mobile Test (Pelican CV-19 Mobile), a digital antigen test, is designed for testing inside homes, businesses, and clinics. Submission for a CE Mark in Europe will soon follow.
Once approved for market, users can use this self-test to quickly and accurately determine if they have COVID-19, including detection of the known new variants. This antigen saliva test utilizes cutting-edge technology with dual targeting to reduce errors, delivering results on an easily readable LCD display. The same sensitivity of 98% is also found in patients with low viral loads found earlier in the infection, often before the onset of symptoms.
"Combining the power of nanosensor and digital detection technology, Canary is offering a 25 second test that can return a highly accurate result with 98% sensitivity and 100% specificity on the spot," said Raj Reddy, President and CEO of Canary Health Technologies. "The challenge with current rapid tests is that too often results are delivered after viral transmission already has happened. Together with accelerated 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 technology in viral detection in saliva, Canary's device has overhauled the need for cumbersome and invasive nasal sampling, previously thought to be the best way to determine the presence of 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 Covid-19 early, before the onset of symptoms or those who never develop symptoms will help reduce household and community transmission," added Reddy, "The potential for its use to safely open businesses, schools and event venues is a game-changer."
The device consists of a handheld re-usable digital reader with direct digital 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.
The device can also wirelessly connected to a smartphone-based app for automated reporting. A result of "positive" or "negative" is given in 25 seconds 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 HIPPA compliant which protects the integrity of protected health information of users.
SOURCE Canary Health Technologies