PBD Biotech broadens patent for tuberculosis diagnostic

Africa-based trials for blood test which detects risk of disease progression are due to begin

PBD Biotech has received grant of its patent application for Actiphage – its incipient tuberculosis (TB) diagnostic – within the regional African Intellectual Property Organization (OAPI). The patent covers the mainly French-speaking countries within West Africa.

Actiphage is used as a diagnostic for early-stage infection. The system can accurately identify live cells of Mycobacteria TB (M.tb) from a blood sample, providing evidence that an individual has an active infection that will progress to full disease – incipient TBI – unless treated.

Meanwhile, improved diagnosis for identifying people with incipient TBI, before they demonstrate clinical symptoms of the condition, remains a strategic priority for the World Health Organization’s #EndTB strategy.

Thus far, PBD Biotech holds two patent portfolios in this area: ‘Mycobacteria detection using bacteriophages’ from 2015 and 2020’s ‘Methods relating to Tuberculosis’, which specifically covers its tests for incipient TB.

The Actiphage patent is supported by a study published in Clinical Infectious Diseases, which was led by Raman Verma and Pranabashis Haldar of the National Institute for Health Research Respiratory Biomedical Research Centre at the University of Leicester.

Using a phage-based blood assay, researchers reported the first concordant evidence to demonstrate associations of Mtb bacteraemia with progressive phenotypes of latent infection, along with active pulmonary TB (PTB). It was duly concluded that Actiphage offered potential as a blood-based diagnostic tool for infectious PTB, while allowing for earlier diagnoses in patients unable to expectorate sputum.

Jane Theaker, chief executive of PBD Biotech, reflected: “Actiphage offers a potential game-changer in the detection and treatment of people with incipient TB. By identifying those with active disease before they start to transmit the bacteria, it offers potential to break the cycle of infection.”

She added: “We are currently working in Zambia and South Africa on clinical studies. We are pleased to report on the grant of this patent as it provides evidence of our commitment to expand our operations and patent portfolio, while protecting our interests in this competitive market.”