The emergence of COVID-19 has exposed a frailty in the ability to rapidly detect and screen new infectious diseases.
British company Iceni Diagnostics is developing a new approach that identifies the virus – not by its genetic code, which can mutate, but by using its reliance on chains of sugars which are constant and unchangeable. The existing prototype product for influenza can detect the virus in less than 20 minutes and could be adapted to identify other pathogens such as Coronavirus.
Viruses typically invade the body through cells in the respiratory tract. These cells are covered in a coat of sugar chains, known as glycans, which are used to recognise beneficial substances. Viruses can utilise these glycans as part of the infection process. This process can also be used in reverse to identify the virus in saliva or nasal fluids.
Professor Rob Field, a glycan science specialist and Director of the Manchester Institute of Biotechnology, is the co-founder of Iceni Diagnostics. The company has developed this diagnostic technique that uses an artificial glycan receptor to capture the virus.
“Right now, everybody is talking about a vaccine for coronavirus but vaccine development, validation, safety-testing, manufacture, regulatory approval and deployment is a time-consuming process,” said Professor Field. “A low-cost, easy to use screening test that can be performed at the point of care is an ideal way to limit initial disease transmission in the country or location of origin.”
Field explained that current COVID-19 tests are largely based on PCR (polymerase chain reaction) that requires a laboratory setting for analysis and relies on prior knowledge of the viral genetic code. “This code can change as the virus evolves, limiting the effectiveness of the test. The Iceni Diagnostics approach uses glycan recognition, which is unaffected by seasonal variation in the genetic code, and can be offered as a handheld home or field-based test.”
Iceni Diagnostics has already developed a series of prototype products that can specifically detect pathogens such as Norovirus and different strains of influenza in less than 20 minutes. Field says that the most advanced product, for equine influenza, is performing well in early stage clinical trials.
The hand-held device uses lateral flow – like a home pregnancy test – to give a simple yes/no answer. It requires no refrigeration and no training, meaning the test is usable in any location, by any person, in order to detect flu or other pathogens.
The current Iceni Diagnostics products detect a single virus. However, the next generation of diagnostics will enable the detection and discrimination of a series of pathogens that give rise to similar symptoms. This would enable, for example, a distinction between flu and COVID-19 in a single sample. This increases the versatility and robustness of the diagnosis. Additionally, the way the virus interacts with its glycan receptor makes it seasonally consistent, so, even if the virus genetic code mutates, it will still be detected – meaning the Iceni Diagnostics’ test should remain effective indefinitely.
Professor Field believes that the device holds huge promise for changing the way we manage global disease: “This new approach, which is based on host-pathogen glycan recognition could potentially result in a more universal detection technique, crucial in early diagnostics of outbreaks.”
Iceni Diagnostics is currently in an investment round to support the validation and roll out the commercial launch of its initial product portfolio. It is also looking at additional funds from the European Union and the Biomedical Advanced Research and Development Authority.
Currently, the U.K. is only testing suspected COVID-19 sufferers in hospitals.