Posted 10 December 2020
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In April this year, as the world came to grips with the global COVID-19 pandemic, Rhinomed CEO Michael Johnson received first hand insight into what was to become one of the major challenges the global health system would face when dealing with the outbreak.
The Melbourne based nursing home his father resides in was one of the first in Victoria to suffer from a COVID-19 outbreak. Four people became infected with all residents being tested on a weekly basis. His father gave Johnson a graphic account of the testing protocol, describing the current gold standard nasopharyngeal swab process as like being ‘stabbed in the brain”. A very real case of an ‘imperfect’ gold standard.
As the extent of the global need for testing became apparent, Rhinomed investigated the solutions further. They discovered that not only was the sampling process extremely uncomfortable and unpleasant for the participant, it was also known that the process could cause coughing and sneezing, meaning healthcare workers administering the swab were in the direct line of fire and at great risk of infection.
Further analysis of existing swabs identified that the load capacity of these swabs was quite small, the time window for sample loading quite short. While not necessarily an issue for RT-PCR testing, both these issues could create a significant issue for Point of Care antigen testing where sample size has a direct correlation to sensitivity and specificity of the test.
According to Rhinomed CEO Michael Johnson, “We had been successfully designing comfortable, well-tolerated nasal devices for over six years with millions of people wearing our devices while exercising or overnight to improve their sleep. We were confident that we could develop a technology that would respond to the issues facing the participant, the healthcare worker and, importantly, one that would work seamlessly with existing pathology workflow processes.”
Some six months later not only has Rhinomed completed development of the all new, comfortable (yes, it really is!) easy to use, self-administered, high load capacity nasal swab, they have now registered it with the US FDA and the Australian TGA with further jurisdictions to follow.
“Having developed the key idea and secured the IP position, our design team from APS Innovations were able to take the ideas and rapidly design and 3D Print the prototypes. Our internal team tested these in our user studies which further informed the process and gave us the evidence we needed to progress. Further pre-clinical validation has been conducted to confirm PCR compatibility and the ability of the swab to detect the SARS- CoV-2 virus in RT-PCR testing in the lab in a spiked study at a range of concentrations. It’s been a great team effort and an illustration of just how Australian innovation can quickly respond to global needs,” said Rhinomed VP of Business Development Peter Jordan.
Nasal swabs remain at the forefront of the Covid testing process. With only two major manufacturers globally, Australia is currently dependent on importing swabs from overseas. “Our novel nasal swabs are not only superior in comfort and yield to alle costing nasal swabs they also present an opportunity to reduce Australia’s dependence on imported kits,” commented Johnson.
Rhinomed will be actively engaging with both Federal and State Governments to work on a future manufacturing program that can not only address state and national clinical needs, but also respond to what is a significant global demand for nasal swabs and test kits.
For further information about Rhinomed swabs visit Rhinomed global or email swab @rhiniomed.global
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