A new clinical trial of Actiphage TB, a ground-breaking phage-based, molecular diagnostic, has been agreed between its developer PBD Biotech, University of Leicester and the NIHR Respiratory Biomedical Research Centre, Leicester (UK).
This is the largest clinical trial for Actiphage TB test, with over 100 patients. It builds on a prior study that demonstrated detection of Mycobacterium tuberculosis (Mtb) in the blood of naive pulmonary TB patients, with a sensitivity of 73% and specificity of 100%. In that study, sensitivity of the assay associated with radiological and microbiological correlates of increased disease severity.
The study will assess Actiphage TB’s performance against the World Health Organization (WHO) minimum reference target product profile thresholds of 75% sensitivity and 80% specificity for a community TB triage test.
Interim results are expected later this year.
PBD Biotech will be on booth #4578 in the AACC Clinical Lab Expo.
More about Actiphage clinical studies.
