We are waiting on TB slides from Johns Hopkins University. The slides to be prepared, the ‘challenge set’, will originate from a clinical trial currently underway in Uganda. Approval to use the challenge set, outside of the clinical trial, requires regulatory approval from the Government of Uganda. The request has been submitted and is likely to be granted during February. The slides will require 4-6 weeks for preparation, investigation, culture evaluation and quality assurance.
Discussions with the University of Pretoria continue to advance regarding an evaluation trial of our Signature Mapping TBDx™ technology. The University is in the process of collecting 1,000 patient sputum specimens over this next quarter. Those specimens will then be evaluated using both a trained microscopist and results from culture. The University plans to initiate its evaluation of TBDx™ in the second quarter of this year.
There are ongoing discussions with The Royal Tropical Institute of The Netherlands on a project to apply TBDx™ imaging technology to the automatic detection of TB cells in progressively developing culture samples. Their staff has captured a series of time-lapse images. The objective of the project, and their hypothesis, is that our technology will detect image patterns of TB in culture much earlier than the 4-6 weeks required to reach an assessment today. Additionally, they are hopeful the technology will be able to help identify TB strains that are multi-drug resistant. Our analysis of these images will begin in early February.