Dr Ben Swift, one of the trial’s co-leads, will present the findings at the American Thoracic Society Conference in Dallas on 21 May 2019.
Despite recent reductions, England still has one of the highest rates of tuberculosis TB in Western Europe (PDF, 8.5MB) and Leicester, where the trial was conducted, has one of the highest rates in England with between 160 and 200 new cases identified each year.
TB is a serious bacterial infection, which can be life threatening if not properly treated with antibiotics. Pulmonary TB of the lungs or throat is contagious, but TB can affect any part of the body.
One of the biggest challenges in human TB is rapid early diagnosis. Early detection of those at risk of developing TB would enable more effective management of the disease.
Traditional tests rely on sputum to detect the infection but almost half of all people with pulmonary TB are unable to produce sputum, particularly in early disease. This contributes to delays in diagnosis and starting treatment, and promotes transmission in the community.
Actiphage, developed by PBD Biotech, is an alternative to bacterial culture. The underlying biotechnology was originally used for the detection of human TB – under the FastPlaque brand – but was only suitable for use on sputum. Now the phage-based diagnostic has been optimised, so it can detect the presence of the mycobacteria in blood in just six hours. This means it may help to improve the speed and reliability of diagnosis for TB patients, and avoid the need for some patients to have more invasive tests performed.
The clinical trial of the new Actiphage test will involve a cohort of patients with both latent and active TB at Leicester’s Hospitals.
Dr Pranab Haldar from the University of Leicester, one of UK’s leading TB research groups, is the lead clinician on the trial and commented, “Many think of TB as a disease of the past and yet it is continuing to affect people, particularly in vulnerable communities across the country. Despite having a modern and well-equipped NHS, a third of patients still wait more than three months after symptoms begin to have a diagnosis made and treatment started.
“Through this trial we are keen to explore the potential of Actiphage to provide better insights into M. tuberculosis infection and determine how the test can support and contribute to tackling this public health problem in the UK as well as internationally.”
Dr Ben Swift, who is also co-founder of PBD Biotech, commented, “Actiphage is novel blood test for TB and is being used for disease management within agriculture where early detection can prevent the unnecessary destruction of the herd. Within the human population it offers the potential to target those at risk of the disease and save lives. This is a game-changing development.”
Findings from the clinical trial are currently undergoing peer review and are due to be announced, in full, later this year.