New diagnostic tool predicts tuberculosis infection with 73% accuracy
A new diagnostic technology has demonstrated the ability to identify human tuberculosis (TB) infection and those at highest risk of developing the disease with high levels of accuracy.
PBD Biotech’s Actiphage assay is marketed as a test for detecting TB and Johne’s disease in cows via a blood or milk test, but has shown in clinical trials to also be very effective in human diagnosis.
Currently, diagnosis is made via the analysis of sputum samples from the lungs, but this method is flawed due to the inability of some patients to produce sputum, and because it struggles to identify the disease accurately in cases of extrapulmonary TB which spread beyond the lungs, a particularly common case in HIV patients.
A study to investigate the efficacy of the Actiphage assay in TB diagnosis enrolled 66 participants, dividing them according to their status as living with active pulmonary TB, latest TB, healthy individuals, and those who were referred on suspicion of TB infection but were found to be healthy.
The patients were tested once and then again 12 months later, and the tool was found to predict TB infection with 73% accuracy, based on which patients were later diagnosed with TB. The tool produced positive results for three participants with latent TB infection, and two of them went on to develop the disease more than six months later, meaning Actiphage could potentially be used to identify latent TB carriers who are at risk of developing an active form of the disease.
PBD Biotech Chief Scientific Officer Dr Catherine Rees remarked: “While we are cautious about generalising from a small sample size, we are optimistic that these initial findings indicate that Actiphage can be used as a tool to help us better understand the dynamics of the infection in humans.”
Dr Ben Swift, PBD Biotech’s Director of R&D, also added: “A blood test is an easy sample to take and process and it gives you a lot of information. If we can detect viable bacteria in the Actiphage test we can say that this individual is definitely infected with a live bug. We see it as quite a powerful tool in addition to what doctors do to confirm the diagnosis of TB and look to monitor treatment in the future.”
The technological pharmaceutical company IMIDEX has been granted clearance from the US Food and Drug …
On 16 August 2023, the US Food and Drug Administration (FDA) officially cleared Artiva Biotherapeutics’ …