TB is a preventable and treatable condition that is second only to Covid as the most fatal infectious disease worldwide. A recent report has highlighted that Actiphage is the only rapid molecular diagnostic currently in development that can detect subclinical human TB from a blood sample, consequently the company has committed to supporting the fight to #EndTB.
Size and urgency of unmet need
Jane Theaker, CEO of PBD Biotech, the developer of Actiphage comments: “The size and urgency of the unmet need for human TB diagnostics has driven our decision to focus in the short term on this goal. The proof of concept clinical trials have gone well, and we are talking to pharma companies about the use of Actiphage for developing therapeutics as well as the application for screening and triage.”
“Research for animal health – Bovine TB and Johne’s Disease – will continue in parallel with academic partners. We are still keen to receive expressions of interest in this research area but will be unable to provide the commercial service in the near term.”
Molecular diagnostic for rapid screening
Actiphage is novel as it uses a bacteriophage, specific to a strain of mycobacteria, to find the bacteria in blood, it replicates quickly breaking open the cell walls to enable identification of the mycobacterial DNA with PCR. This allows swift screening of a population and early diagnosis of those that are at most risk of developing the disease.
Most other tests, such as IGRA, detect the host’s immune response and this occurs later when the disease has progressed.
Additionally, other tests use a sample of sputum which is difficult for children and many adults to produce.
WHO Target Product Performance
WHO and FIND have identified the development of rapid molecular diagnostic as a research priority and created a clearly defined Target Product Performance criteria. This has not happened in animal health. Therefore, PBD Biotech has a clear route to market for its Actiphage test in human health.
Knowledge emerging from the human programme could benefit animal health.
The Treatment Action Group (TAG) Pipeline Report Tuberculosis Diagnostics published in November 2022, highlights Actiphage® as the only blood-based diagnostic in development for subclinical tuberculosis that directly detects mycobacteria and provides an early indication of disease progression.