Reproduced with thanks to Business Weekly

A collaboration between industry and academia is developing one of the most innovative and important rapid diagnostics lateral flow tests for Covid-19.

What makes Iceni Diagnostics’ duplex test different from any other lateral flow test currently on the market is that it is based on glycoscience (carbohydrate chemistry and biology), relying on sugars not antibodies to make the diagnosis. As a result, the pioneering test can tell in minutes whether a person is suffering with flu or coronavirus – which is especially useful given the virus’ evolving symptoms and, in particular, the more flu-like symptoms of the Delta variant. Perhaps most importantly, this test is additionally mutation-proof so can pick up new variants as they appear.

Professor Rob Field, Iceni Diagnostics’ Chief Scientific Officer, explains: “Using sugars as specific targets for infectious disease identification is a growing and exciting new approach to diagnostics. The theory was, if it worked for flu, then it was a reasonable assumption that it would work for coronavirus too. They are both respiratory pathogens, and there was this recognition that Covid-19 was likely to be a sugar-binder. But, in fact, what works for flu is very different to what works for coronavirus.”

University of Warwick’s input was key in terms of adding a polymer (a large molecule made up of chains of linked repeating subunits) to the work Iceni Diagnostics was doing with sugars (glycans), transforming it into something that works for Covid-19 too.

Professor Matthew Gibson heads up the academic research team from the University of Warwick (Department of Chemistry and Warwick Medical School). He says: “The most important point to highlight is the fact that academia and industry working together along the basic questions, leading to the applied applications, really does work. And these collaborations really are two-way.

“Our technology uses polymers to present sugars which recognise the virus rather than antibodies – and so, in crude terms, we provided the ‘linker’, the bit that has to bind to the virus or toxin or hormone, or whatever it is you are trying to detect. This was one of those cases where details matter an awful lot, and small changes can have enormous impact. The polymers have additionally succeeded in reducing the non-specific inter-reactions (that is, the false positives) whilst helping us to change how that sugar is presented.

“But where we have added our area of expertise, we have also gained invaluable knowledge regarding commercialising a product – something an academic would rarely consider.”

Professor Field agrees: “The jump from academic idea to commercial product is often unfeasible. It’s very easy to dream up academic ideas but they often cost a fortune and are not practical for real world use. What’s required is the more pragmatic industry approach. You need to be aware of the cost of your goods and the practicality of your scaleup – neither of which are ever questioned in an academic publication. It requires a different outlook and mindset to drive all that through, which is why it’s the combination of industry and academia that’s so beneficial.”

The two parties have since agreed an exclusive global licence to integrate the key virus detection intellectual property (IP) developed by the University of Warwick into Iceni Diagnostics’ commercial programmes – and it is expected to have even broader applicability than just flu and coronavirus.

Professor Field says: “Now that we are confident this polymer approach does offer a lot of opportunity, particularly with Covid-19 as demonstrated, then we want to look at using this elsewhere – for example, in relation to our flu products, which includes our equine flu product, to see if there can be any added value there.

“We also feel the polymer approach could really help to improve the diagnosis of Norovirus where you are dealing with a stool or vomit sample, which can be far more challenging than a saliva sample.”

Currently in academic peer review, the revolutionary duplex test is in late-stage development, and is set to come on to the market early next year. Advanced prototyping has been outsourced to Bedford-based manufacturer Mologic, a company experienced in developing lateral flow devices and have the necessary quality systems to facilitate CE marking and regulatory approval.

Professor Field explains: “The underlying science and technology all work and that’s what’s been submitted for academic peer review – showing the principle really clearly that it can identify Covid-19 positive patients with a near 100% success rate.

“As the test we are developing is nothing like anyone else’s, we have happily gone the extra mile to get the community on board, because what we’re doing is so ground-breaking.”