With this new test, vulnerable patients with long-term conditions, such as Cystic Fibrosis (CF), Chronic Obstructive Pulmonary Disease (COPD) and Asthma, can keep a check on their health by measuring the activity of pathogenic bacteria in their lungs with a simple test using a sample of sputum.
Many people with long-term respiratory problems get frequent flare-ups or exacerbations of the bacteria living in their lungs and with each event the lungs become damaged as a result of the inflammation that is caused. The key to preserving lung function is to keep fit and healthy, treat infections quickly and use the right antibiotic medicines for the current exacerbation. Over time, these exacerbations cause the loss of lung function and in the most extreme cases the only solution is a lung transplant.
One of the challenges is to quickly detect an exacerbation before it becomes too severe. This is where a home alert system could help patients with COPD and CF, who are often colonised with the pathogen Pseudomonas aeruginosa. The Aseptika test can detect when this bacterium starts to flare out of control. In healthy people, this bacterium can be eradicated by treatment with antibiotics. Those with respiratory problems cannot get rid of it and it hides within the lungs awaiting some other event to trigger sudden multiplication, leading to serious harm for the patient. The Aseptika test detects how active the bacterium has become and whether another round of treatment is required.
The second challenge the test addresses is knowing when the infection is under control or whether the correct antibiotic medication been used. By following the levels of activity of the bacteria, it is hoped that clinicians will be able to decide whether an infection is under control after two days of treatment, rather than waiting seven days to see whether the treatment is effective. This means that different medication could be utilised if the first lacks efficacy. Pseudomonas aeruginosa can rapidly mutate once established in the lungs and there is no certainty that the medication that controlled the last exacerbation will be effective for the next one, even in the same patient.
The Patent granted to Aseptika in the UK (Patent GB2494953), with worldwide applications taking place under the International Patent Treaty, tracks the presence of two very different materials (biomarkers) produced by the bacterium. The test is currently being used in a clinical trial with volunteers who have Cystic Fibrosis and it is hoped to make a home-use version available within two years.
The Aseptika test was a concept put forward to the NHS and the Technology Strategy Board as one of a number of solutions to help people with long-term conditions to stay well at home, under the Small Business Research Initiative (SBRI) programme. Funding was used by the Company to undertake an initial proof of concept, which was followed with a larger-scale trial with volunteers in the East of England. As part of this, the Company received support to file a patent application and undertake the process of steering its invention through the rigorous examination pathway by the UK's Patent Office before being granted on the 25th September 2013. The process took two years to complete.
Karen Livingstone NHS England Director of SBRI and EAHSN Director of Industry Engagement commented, "This is great news for Aseptika and allows the Company to move forward with development knowing that its intellectual property has been protected. The SBRI funds support innovative organisations to develop new technologies that we will need to advance healthcare and for the UK to be a World leader in this field. We recognise that in holding the patent protection a company can build and grow its place in that global market and the SBRI scheme is keen to support business growth as well as resolving healthcare problems. In this particular call for solutions to help people stay well at home, we received 77 applications. Aseptika was one of 5 that were awarded the two phase contract."