The term superbug is probably over-hyped, but it is impossible to escape the fact that there is a threat to health from a growing number of harmful and potentially lethal viral and bacterial infections.
It would also be easy to believe that Britain is the only nation where the problems are serious, but these infections are a concern globally.
C.diff and norovirus are names that make frequent headlines, yet they represent just a few of quite a long list.
Such infections grow and spread with frightening speed, and thrive in closed environments such as hospital wards or cruise ships.
While for most sufferers it means an uncomfortable few days of diarrhoea, vomiting and discomfort, for the frail and vulnerable, the infections can be deadly.
Many pathogens become true superbugs — antibiotic resistant — but it is the ability of viruses and bacteria to mutate that makes it imperative to diagnose the exact strain in any patient.
For healthcare practitioners, the emphasis has to be on alleviating mortality rates, but with the spotlight on hospital budgets, reducing avoidable costs is also a key issue. Closing wards because of an outbreak is very expensive.
Andrew Maxwell, chief executive of the Native Antigen Company (NAC), outlined both the problems and the need for rapid and highly accurate diagnosis.
He explained: “These things grow and spread like wildfire, but by the time ward staff discover they’ve got a serious outbreak, it’s already too late.
“What they lack is a simple yes/no test that can be carried out daily on the ward, then a further test to identify the specific strain, and the stage it has reached, to create a therapy regime.”
His company is the newest kid on the Cherwell Innovation Centre block, having spun out of Hybrid Biosystems, now PsiOxus, in December 2010.
NAC has developed techniques to produce native antigens that in laboratory tests, called in-vitro diagnostics or IVD, behave in exactly the same way as they do in the human body.
Antigen is an abbreviation of antibody generator. The antigens are the molecules of infection, and trigger an immune response in the body to fight and kill them.
Recombinant antigens can be easily and quite cheaply produced, but they lack the specificity to identify a mutation with pinpoint accuracy, and the sensitivity to classify which of the infection’s multiple stages it has reached.
Developed from PsiOxus’ expertise with viruses and bacteria, NAC grows the pathogens and then isolates and purifies the harvest to create the native antigens.
Mr Maxwell said: “It is difficult. But using native antigen helps IVD manufacturers to achieve the required specificity of 95 per cent or more, and that is the level of accuracy demanded.”
Concentrating initially on Europe, NAC’s products have created considerable interest around the continent from the manufacturers of in vitro diagnostic kits.
The company’s target market is these manufacturers, not sales to end-users.
NAC is presently aiming at respiratory and gastro infections, as these show the highest mortality rates.
Their antigens are used in two ways. One is as a control to ascertain that the diagnostic test is performing correctly.
The second, known as “antigen down”, involves the coating of the wells of a test plate or the impregnation of the absorbent pad of a lateral flow diagnostic kit.
In either case, a spot of a body fluid is placed in the well or on the pad, creating a readout for the clinician. Using plates with multiple wells, screening tests are robotised and produce results that can be instantly compared with a calibration curve.
Mr Maxwell was formerly the consultant to Hybrid Biosystems on IVD, before heading up the new company.
NAC is 70 per cent financed by the Mercia Seed Technology Fund, a West Midlands-based organisation supporting leading healthcare technologies with global potential. The balance is provided through business angels and private investors.
But a significant source of revenue is co-development work on test kits with leading IVD manufacturers.
The antigens are combined with the necessary reagents to produce kits that the manufacturers guide through testing and regulatory approval.
Such co-development is scheduled to produce 40 per cent of NAC’s first year revenue in milestone payments.
“Co-development also means long-term revenue for us,” Mr Maxwell said.
“Even if a rival can make a similar product, changing the antigen would mean a kit maker going through all the approval process again — and that is time-consuming and expensive.”
The IVD market is expanding rapidly and is currently estimated to be worth £100m.
Mr Maxwell added: “The great thing is that we’ve only been going a few weeks, but we have products ready to sell, and there’s not many start-ups that can say that”
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