Ground-Breaking Phage-Based Diagnostic Kit for Laboratory Tuberculosis Testing Presented at AACC 2023

Improved diagnostic tests for latent tuberculosis infection are crucial to better identify individuals at the highest risk of progressing to active tuberculosis. Diagnostic laboratories play a key role in combating TB and require innovative techniques to identify and isolate Mycobacterium tuberculosis (Mtb), the causative agent of the disease. At the AACC Clinical Lab Expo, PBD Biotech (Birmingham, UK) is showcasing Actiphage, a phage-based test that detects Mtb in the blood – which is considered an early indicator of ‘active’ TB disease. The test shows potential for screening latent TB and drug management. Actiphage combines phage-based DNA extraction with polymerase chain reaction to identify low levels of viable Mtb in blood.

Actiphage was also highlighted in the AACC webinar titled "Phage-Based Laboratory Diagnostics Role in the Detection of Tuberculosis," sponsored by PBD Biotech. At the webinar, experts discussed the epidemiology of tuberculosis and the limitations of current tests that assess host response. Attendees gained insights into how phage-based diagnostic technology can be employed to detect incipient and active TB. PBD Biotech recently launched one of the largest clinical trials to date for Actiphage TB, which builds upon a previous study that demonstrated the detection of Mtb in the blood of naive pulmonary TB patients. Furthermore, PBD Biotech has successfully secured a US patent for its diagnostic kit associated with Mycobacteria detection using bacteriophages, specifically relating to the diagnostic kit. This further strengthens the protection for the Actiphage technology.

“We already have a granted US Patent for the specific method steps, but this new allowance relates to the specific components that make up the Actiphage TB diagnostic kit, strengthening our rights,” said Jane Theaker CEO of PBD Biotech. “We are particularly pleased with this result, claims covering diagnostic kits are notoriously difficult to obtain before the USPTO as the components of the kit are generally considered individually and not in relation to how the kit is to be used.”

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