Millions of people suffer each year from viral diseases such as flu. These ailments develop quickly and can spread rapidly – at huge cost to the healthcare system and sometimes with severe consequences for the patient. Globally, flu epidemics are responsible for at least 500,000 deaths each year, with the very young and the elderly being at particular risk.
The speed of medical response is vital, as antiviral drugs are only effective if taken within two to three days after the onset of symptoms – so doctors need a rapid, simple and low-cost test that can be carried out at the clinic or even the patient’s own bedside.
The current “gold standard” test for detecting these viruses is based on polymerase chain reaction (PCR) technology. This test can’t be done at the patient’s bedside, however – the sample must be sent to a central laboratory for processing, which causes delays in diagnosis and treatment.
So in 2008 a consortium was created in North East England to devise a solution to this problem. Led by UK nano-biotechnology firm Orla Protein Technologies, the partners in the VIRASENS project included Newcastle University professors Jeremy Lakey and Geoffrey Toms, the UK’s Health Protection Agency’s Public Health Laboratory in Newcastle and regional technology centre RTC North.
The intention was to create a device which would allow doctors and paramedics to perform rapid near-patient testing without the need for complex equipment. A successful outcome would improve the speed of treatment, help to contain the outbreak, benefit patients and reduce the cost to the healthcare system.
The £1.1m project, part-funded by the Technology Strategy Board, the UK government’s innovation agency, has successfully developed biosensors for three of the main viral culprits – the Influenza A and B viruses and Respiratory Syncytial Virus (RSV). It has also resulted in the creation of a new company, OJ-Bio Ltd, to commercialise the technology.
The Health Protection Agency collected nasal secretions, nose/throat swabs and nasal aspirates from patients and used these samples to test the consortium’s technology – Surface Acoustic Wave (SAW) biosensors – against the current benchmark PCR method, as well as another commercially available test.
The results showed that the new SAW biosensors gave results in around 10 minutes, had good levels of diagnostic sensitivity for the three test viruses and did not give false positives – they demonstrated 100% specificity even when other viral analytes were present.
Equally promising is the fact that the SAW biosensors have the potential to communicate the results via wireless networks or a smart phone connection, so that further medical attention can be given if needed. This means that as well as being used in clinics, devices based on the technology could be used for community or home use.
SAW chips are already mass manufactured for use in mobile phones. What the VIRASENS project has done is find a way to coat SAW chips with proteins oriented on the device surface to give highly specific responses when they come into contact with samples containing the disease concerned. The reaction that takes place is turned into an electronic signal which can be combined with a small reader to transmit and receive data.
Dr Andrew Sails, Head of Molecular Diagnostics and R&D at the Health Protection Agency Public Health Laboratory in Newcastle says “This is very exciting technology which has the potential to revolutionise point of care testing for infectious diseases.”
The company formed to commercialise the technology is Newcastle-based OJ-Bio, a joint venture involving global electronics company Japan Radio Company (JRC) who provide the SAW chip expertise and Orla Protein Technologies, the UK company that provides the protein surface technology.
Dr. Dale Athey, CEO of OJ-Bio, said: “The VIRASENS results are a great boost for our technology and allow us to approach major companies who will want to produce and sell these devices. We are also developing products for other diseases, as the technology works for any immunoassay based test and on samples from blood or urine, as well as saliva”.
The company also recently announced that it is starting clinical trials of a SAW device for the point of care detection of periodontal gum disease – another infection with huge economic impact, estimated at £2.78 billion per year in the UK alone.