A highly accurate, non-invasive, disposable breath test that aims to detect the virus before the onset of symptoms and in less than 3 minutes could be on the global market by Q1 2021
The ultra-rapid, highly accurate breath test for the detection of COVID 19 is designed to identify those who are acutely infected with SARS COV-2 as well as those who have not yet developed symptoms.
The hand-held mobile test is suitable for mass screening and repeat testing which will be critical to opening the economy, reducing transmission and helping to end the pandemic.
Through the capture of unique breath biomarkers, the disposable digital test, which mitigates contamination, uses next-generation nanosensors and cloud-based artificial intelligence for analysis.
This pivotal clinical trial of 750 subjects will yield preliminary results before the end of December, and will aim to be in the market early 2021.
Cleveland, USA /Delhi, India, December 2020: US-based Canary Health Technologies (Canary) and DIVOC Laboratories (Divoc), a Delhi-based laboratory certified by the National Accreditation Board for Testing and Calibration Laboratories (NABL), will collaborate on a ground-breaking trial to develop an ultra-rapid and highly accurate breath test for the detection of COVID19. The hand-held digital test which requires minimal training can be performed at the point of care without the need of a lab. Canary’s cutting-edge R&D and manufacturing facility based in Bangalore is at the center of this technological development.
Using exhaled Volatile Organic Compounds (VOC’s) found in human breath as biomarkers of the virus, this screening test (ASU Detect CV19) is designed to detect the virus in people with and without symptoms. US CDC recently noted that most of the COVID spread is caused by people without any symptoms. While current tests measure the viral load in a person to determine if they are infected, Canary’s breath test detects the person’s metabolic response nearly immediately after infection.
Viral infections increase oxidative stress. The highly reactive free radicals produced by oxidative stress are powerful biomarkers of the diseases found in exhaled breath. The presence of unique VOC signatures in COVID-19 and similar viruses like rhinovirus, influenza, MERS and SARS are well established. Designed to detect a COVID-19 infected person in less than 3 minutes, the disposable breath test, which mitigates the risk of contamination, uses highly sensitive nanosensors to collect breath samples and cloud-based pattern recognition technology to determine if a person is infected.
This pivotal trial in Delhi will be the first and largest clinical trial using a real-time breath test for the detection of an infectious disease with cloud-based artificial intelligence for pattern recognition as the analytical tool. It will be carried out according to international Good Clinical Practice (GCP) standards. The trial is being conducted under registration with the Clinical Trials Registry- India (CTRI) and the trial protocol was approved by the ethics committee of the Good Society Ethical Research. Trials in the United States and Europe are also being planned and are due to start before the end of 2020.
ASU Detect CV19 is developed on Canary’s powerful breath analysis platform which is also being developed to diagnose cancer, infectious diseases and inflammatory diseases. In 2019, a clinical trial in Canada demonstrated that the platform can detect lung cancer with high sensitivity and specificity. Proof of concept and pivotal trials for a number of high-burden diseases are being planned in the US and Asia. A trial to diagnose rheumatoid arthritis is due to start in New York in January, 2021. Canary has also performed bench studies for tuberculosis, one of the deadliest diseases, with promising results, indicating that a highly sensitive breath test for TB is within reach. Discussions are on-going with global health actors to start a trial for TB detection at the start of 2021.
Raj Reddy, CEO of Canary Health Technologies, an expert in nanosensor technology, said:
“Canary is thrilled to collaborate with Divoc which is a world-class lab focused on best-in-class technologies and innovative delivery of services. We believe Canary's breath diagnostic platform is the future of COVID detection. Our cutting-edge technology enables easy, rapid testing every few days in order to optimize safety in workplaces and other settings. Our unique strength will be our ability to detect COVID in under 3 minutes before the onset of symptoms which will be critical in reducing transmission and ultimately put an end to the pandemic. The ultra-rapid breath test is ideal for use in doctors’ offices, nursing homes, airports, and large event venues."
Not only will ASU Detect CV19 have the ability to detect the disease from the time of infection, because the results are analyzed in a cloud-based system, the platform will also provide real-time surveillance for disease monitoring, and track and trace initiatives. Health authorities will be able to see disease hotspots as they form and respond quickly. Ultra-rapid screening at airports and other high density and transmission areas will drastically reduce the potential for disease transmission, and allow COVID-free people more freedom of movement.
Professor Ashok Rattan, the Principal Investigator of the trial, a prominent lab scientist who was formerly professor at the All India Institute of Medical Sciences (AIIMS), New Delhi and Lab Director of PAHO / WHO administered Central Asia Regional Economic Cooperation Program, said:
“This is next-generation technology and has the ability to completely revolutionize testing for COVID-19 and play a critical role in stopping the spread of the virus. Currently there does not exist an ideal test that could be a real time, non-invasive, highly accurate mass screening tool to be used to reduce transmission. The biomarkers in the breath are as unique as our fingerprints in the identification of diseases. The Canary breath test has the potential to responsibly open the economy and protect the population.”
Dr. Kanav Kahol, CEO of DIVOC Laboratories, a renowned healthcare innovator said:
“We are excited to be partnering with Canary on this ground-breaking technology. With this test, we are accelerating into the digital age where healthcare is provided on the spot. The potential of this transformative platform is almost limitless. Beyond COVID-19, this digital platform can detect many other diseases including cancer and TB. The easy-to-use, mobile nature of the test can make an enormous health impact in a country like India where tele-medicine is becoming the norm. Personalized healthcare will see the biggest surge in the coming decade and the Canary breath test platform will be uniquely positioned to lead that movement.”
The trial will see the collection of breath samples from 750 people - both COVID-19 positive patients and those who do not have the virus. They will be asked to breathe into the device. The device will then translate their breath biomarkers into electronic signals which will be transmitted to a centralized “lab in the cloud” for analysis. Preliminary results are expected before the end of December 2020.
If the trial is successful, Canary Health Technologies will seek to move quickly to apply for fast-track regulatory approval while continuing to trial the test in real-world settings such as at airports, in resorts and in other high density areas.
About Canary Health Technologies
Canary is a medical technology company that uses proven biomarkers, proprietary nanosensors and AI-powered software to map and uncover data in human breath so cancers, inflammatory and infectious diseases can be detected early and treated more successfully. The ultra-rapid digital test uses raw exhaled breath with no pre-processing or shipping of samples and with results in less than 3 minutes. The cloud-based solution also enables real-time disease surveillance. The hand-held mobile platform is aimed to be used in primary healthcare settings with minimal infrastructure and training.
About DIVOC Laboratories
DIVOC Laboratories was formed by leading global health experts and practitioners to enable a digitally empowered integrated approach to diagnostics. The multi-disciplined team from United Kingdom and India is committed to bringing 21st century innovations into diagnostics. DIVOC’s aim is to provide a modern, quality driven digital approach to laboratory operations that provide consumers unprecedented convenience, reliability and impactful innovations. It has received NABL certification to run molecular biology testing in our lab and have ICMR permission for running RT PCR COVID 19 testing.
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