Locally developed 60-second breath test receives provisional authorisation from HSA

An easy-to-use breath test that can accurately detect COVID-19 within a minute has received provisional authorisation from Singapore’s Health Sciences Authority (HSA). Developed by Breathonix Pte Ltd, a spin-off company from the National University of Singapore (NUS), the BreFence™ Go COVID-19 Breath Test System is the first breath analysis system to secure provisional authorisation in Singapore.

Breathonix is now working with the Singapore Ministry of Health (MOH) to run a deployment trial of their technology at Tuas Checkpoint where incoming travellers will undergo screening with the BreFence™ Go COVID-19 Breath Test System. This breath analysis will be carried out alongside the current compulsory COVID-19 antigen rapid test.

Breathonix is founded by three NUS graduates, Dr Jia Zhunan, Mr Du Fang and Mr Wayne Wee Shi Jie, along with Dr Jia’s PhD advisor, Professor T. Venky Venkatesan. It is supported by the NUS Graduate Research Innovation Programme (GRIP), a scheme that encourages talented NUS graduate students and research staff to establish and run high potential start-ups based on deep technologies.

Under the leadership of Professor Freddy Boey, Deputy President (Innovation & Enterprise), the NUS GRIP team has been working closely with Breathonix to achieve this milestone, providing expertise and equipment to carry out biomedical studies to validate the technology, and leading them to obtain regulatory approvals for the deployment of the system.

“We are proud to play a part in Singapore’s fight against COVID-19 by turning our cancer detection technology into a system that rapidly screens for the coronavirus. After months of hard work, we are delighted that the BreFence™ Go COVID-19 Breath Test System is now ready to be deployed to protect the nation. Our team is grateful for the invaluable support and advice provided by NUS,” said Mr Du, Co-founder and Chief Operating Officer of Breathonix.

Fast, non-invasive breath test

The BreFence™ Go COVID-19 Breath Test System works by detecting Volatile Organic Compounds (VOCs) present in a person’s exhaled breath. VOCs are produced by various biochemical reactions in human cells. As the VOC signature from a healthy person’s breath vary from that of a person with an illness, changes in VOCs can be measured as markers for diseases like COVID-19.

The breath test is simple to administer by trained personnel but does not require medically trained staff or laboratory processing. A person only needs to blow into a disposable one-way valve mouthpiece connected to a high-precision breath sampler. The exhaled breath is collected and fed into a cutting-edge mass spectrometer for measurement. A proprietary software algorithm analyses the VOCs biomarkers, and generates results in less than a minute. Any individual screened positive will need to undergo a confirmatory Polymerase Chain Reaction (PCR) COVID-19 swab test.

Dr Jia, Chief Executive Officer of Breathonix, explained, “Our breath test is non-invasive. Users only need to breathe out normally into the disposable mouthpiece provided, so there will not be any discomfort. Cross-contamination is unlikely as the disposable mouthpiece has a one-way valve and a saliva trap to prevent inhalation or saliva from entering the machine.”

The breath analysis system underwent clinical trials at three locations conducted from June 2020 to April 2021. In Singapore, trials were carried out at the National Centre for Infectious Diseases and Changi Airport while the third trial was carried out in Dubai, in collaboration with the Dubai Health Authority and the Mohammed Bin Rashid University of Medicine and Health Sciences.

Next steps

There is strong commercial interest in the BreFence™ Go COVID-19 Breath Test System, and Breathonix is in discussion with several local and overseas organisations to use the system.

The NUS GRIP team led by Prof Boey will also continue to render support and advice to Breathonix.

Prof Boey said, “Securing provisional authorisation in Singapore is a major milestone for Breathonix, and NUS is very proud of this achievement by our start-up. This adds to the University’s ongoing efforts to help Singapore fight the COVID-19 pandemic on multiple fronts.”

“The pandemic is likely to go on for several years. Mass, repeated testing has to be widely adopted as a key public health strategy to support the safe reopening of economies, and Breathonix’s home-grown technology hits the right spot. I’m confident that their novel technology will make a significant contribution towards protecting the safety and health of Singaporeans and the global community,” he added.

 

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