UK-based Iceni Diagnostics is developing a home-use SARS-CoV-2 diagnostic using glycan biology with the goal of having the test validated by autumn. Development of the hand-held device is being conducted at the University of East Anglia & John Innes Centre (JIC) spinout and supported by scientists at the Manchester Institute of Biotechnology, led by its director, professor Rob Field, co-founder of Iceni Diagnostics. The prototype device uses lateral flow technology similar to a home pregnancy test and gives a simple yes/no answer of the presence of the virus from a nasopharyngeal swab sample, in about 15 minutes.
While the test is undergoing clinical assessment, Iceni Diagnostics is in parallel working to ensure that mass production can be rolled out once validation is completed. Product development manager Chris Liggett said that the firm is “in discussions with two leading lateral flow device manufacturers who have the capacity and availability to support our launch plans for both the UK and overseas markets.” Early evaluation on SARS-CoV-2 clinical samples has yielded “promising results,” she said. “We still have independent validation and early-phase manufacturing to pin down ahead of making devices available.”
Unlike current laboratory tests for SARS-CoV-2 that rely on time-consuming and expensive polymerase chain reaction (PCR) technology to amplify viral nucleic acids, the rapid test being developed by Iceni Diagnostics exploits carbohydrate-pathogen recognition to detect the virus, explained Simone Dedola, R&D manager. “Animal cells are coated with a variety of carbohydrate chains that play a key role in determining host-pathogen interactions (i.e. carbohydrates on the surface of human and animal cells differ and this contributes to determining whether the human or animal can be infected and by what pathogen). Often, the pathogen-carbohydrate interaction is very specific, and this can be exploited to gain selectivity in discriminating between pathogens.”
Iceni Diagnostics’ patented host-pathogen glycan recognition (HPGR) technology harnesses this principle through the use of gold nanoparticles coated with host carbohydrate structures. The carbohydrate molecules selected are recognized specifically by the target pathogen, say, SARS-CoV-2, or a human influenza virus, and will bind only to that pathogen if it is present in a sample.
The HPGR technology has advantages over PCR-based lab diagnostics for viruses, Dedola indicated, not least in that the glycan-based approach doesn’t require a prior knowledge of the viral genetic code, which can change as the virus evolves over time, and potentially limit test effectiveness. This means that glycan recognition is also “unaffected by seasonal variation in the genetic code,” he suggested. “The key to the Iceni technology is the ability to make the appropriate carbohydrate ligand for the specific pathogen.”
While the current Iceni Diagnostics SARS-CoV-2 test kit is designed to detect a single virus, Field suggested in a recent statement that the next version of the test will enable the detection and discrimination of a series of pathogens that give rise to similar symptoms. Autumn launch of a coronavirus test might be particularly timely, as an HPGR diagnostic could feasibly be developed help to support differentiation of “flu vs. coronavirus.”
“A duplex coronavirus/generic flu test will provide a rapid differentiation between people with seasonal flu and coronavirus, avoiding unnecessary mass self-isolation and the consequent disruption to society and the economy,” Dedola told GEN. “These two different types of virus bind to different sugars, allowing the Iceni Diagnostics HPGR technology to discriminate between the two in the same sample and on the same device.”
“This would enable, for example, a distinction between flu and COVID-19 in a single sample, which increases the versatility and robustness of the diagnosis,” Field had noted. “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 in the longer term.”
The final SARS-CoV-2 test will be manufactured as a handheld or field-based lateral flow device that is “ideally suited to triage testing,” Liggett continued. Offering an easy-read diagnosis in just minutes the test would facilitate “rapid identification, isolation, and management of infected patients and clearance to return to work/home for uninfected patients on a timescale not available with PCR testing.” Pricing has yet to be finalized, but the costs will be lower than comparable PCR costs, Liggett asserted.
“This technology can be easily incorporated in a standard lateral flow device and absorbed in the current widely available manufacturing industry for this type of device. Self-contained, portable, and easy to use by anyone, it can be deployed in multiple locations—hospital, pharmacy, bedside, practices, community sites—care homes, workplaces, schools and individual homes.”
Assay assessment is being conducted in collaboration with a local NHS hospital, and Iceni Diagnostics is also working with its clinical diagnostics lab to carry out more extensive testing, which will be followed by independent validation studies. When asked whether the company was in discussions with the U.K. Government or Public Health England, Liggett acknowledged, “… these connections are on our radar.” The firm can foresee test supply via the NHS (in the UK) or over-the-counter. Regarding distribution,”the tests are simple to use with minimal instruction and need no refrigeration, making them ideally suited for use in multiple global locations, in medical, community, or home environments.”
The HPGR technology platform has been developed on the back of years’ of collaboration between Iceni Diagnostics’ CSO and co-founder, professor David Russell, PhD, emeritus Professor of Chemistry at the University of East Anglia (UEA), and company CEO, Field, then a project leader at the BBSRC supported John Innes Centre and Honorary Professor of Chemistry at UEA. Having demonstrated the utility of the platform to rapidly discriminate human from avian influenza virus, the researchers founded Iceni Diagnostics in 2014 as a spin-out from UEA and the John Innes Centre. Field recently joined the University of Manchester as Director of Manchester Institute of Biotechnology (MIB).
Based at the Norwich Research Park Innovation Centre, Iceni Diagnostics is leveraging the HPGR technology for the development of a pipeline of carbohydrate-based therapeutics and point-of-care diagnostics for infectious diseases. “Iceni Diagnostics and MIB will be working closely together to progress this and other carbohydrate-based technologies to commercial realization,” Liggett said.
The HPGR technology is ideally suited to the development of rapid diagnostics, the company believes. The “only” change is the carbohydrate-based ligand, which provides the specificity, “therefore the deployment of our lateral flow diagnostic can be rapidly adapted to other pathogens,” Dedola commented to GEN. Field suggested that the company’s technology may also hold huge promise for changing the way that global disease is managed. “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,” he said.
The Iceni Diagnostics’ portfolio includes tests for human norovirus and for human and equine flu viruses. “Diagnostics for influenza are advanced,” Liggett noted, “but on hold in favor of coronavirus work right now.” The equine flu test is undergoing final stages of beta testing, and is planned for launch next year, targeting the performance horse sector, such as racing, international competition and breeding. “It is these animals that are regular travelers and therefore at greatest risk and require the highest levels of protection.” Iceni Diagnostics had expected that the equine flu diagnostic would represent its first commercial launch of the HPGR platform , but this will likely be superseded by a SARS-Cov-2 diagnostic. “There is a strong pipeline of products following, including norovirus and human flu diagnostics, planned in the next two years,” he said.
A variation on use of the HPGR technology as a pathogen detection system could allow the same carbohydrates to be harnessed to prevent infection, by binding to pathogens and so blocking their ability to bind to human cells. “Iceni Diagnostics is exploring this option,” GEN learned. Moving into the therapeutics field would involve a different scale of time- and cost-implications for product development, Liggett commented. “Nonetheless, Iceni Diagnostics does also have nascent carbohydrate-based therapeutics work ongoing.”
The company has been funded to date by contract work, grant funding from the U.K. and EU, and seed corn financing. Further investment is being sought to speed the coronavirus product to market. Iceni Diagnostics is currently in an investment round to support the validation and roll out the commercial launch of its initial product portfolio. The firm is also looking at additional funds from the EU and BARDA. “It’s all about growth and getting product to market quickly,” Liggett stated. “A swift entry to the coronavirus diagnostics market will generate the revenue to grow the business, to advance diagnostic products for human, avian and equine influenza and to support further development of carbohydrate therapeutics work.”