In this series of blog posts we have introduced you to TBDx™ and how the journey to automatically detect TB bacilli in stained sputum slides using a digital camera, slide loader, microscope, and algorithms originated. We exposed the creative process that led us to new intellectual property discoveries that:
- Automatically focus a digital camera to capture high-quality slide images,
- Integrate multiple technologies into one seamless automated platform,
- Intelligently capture digital images, and
- Apply sophisticated computer-vision detection algorithms to complex human visual challenges.
What began as a simple query to understand the impact of our existing core image analysis technologies on the detection of TB bacilli evolved into the development of a sophisticated and fully-automated multi-disease diagnostic technology platform.
Today there are professionals in the scientific community considering the TBDx™ platform for automated detection of many tropical and non-tropical diseases. A short list of these include malaria, leprosy, leukemia, sample cells from an FNA breast biopsy, or even the examination of patients with dengue fever. In general, any clinical routine that relies on microscopy for diagnosis could be an application for Signature Mapping™ and its related automated microscopy technology.
These initiatives have led to groundbreaking capabilities and important new intellectual property. The challenges have not been trivial, but the effort has produced a unique solution with the potential legacy of saving lives. The next step, as you can surmise, is successfully working through the extensive technology evaluation process previously discussed. We have made significant strides in this area and will continue to focus our efforts on satisfying the requirements of evidence-based science.
Over the coming weeks TBDx™ will go through a clinical evaluation in South Africa as part of a much larger clinical study being conducted by The Center for Tuberculosis. The performance of TBDx™ will be evaluated based on the processing of 1,600 patient cases randomly selected from all participants in the overall clinical study. The study evaluation protocol follows well-understood evidence-based scientific method. The study will not only evaluate performance comparisons with conventional microscopy, but also begin to more fully quantify the cost benefits of the sequential use of TBDx™ and GeneXpert™ in a layered diagnostic approach.
In addition to the clinical trial to be conducted in South Africa, there are other geographically diverse opportunities in the pipeline that we are diligently moving forward.
- The Liverpool School of Tropical Medicine has expressed an interest in evaluating TBDx™, in Nigeria, as part of its ongoing clinical work. The study is expected to commence during January 2013.
- The Japan Anti-Tuberculosis Association, the same organization that provided panel slides for our internal evaluation of algorithmic precision, has also expressed interest in the evaluation of the TBDx™ technology. This is in the early stages of discussion and no study protocol or testing objectives have yet been discussed.
- Study protocols for multiple TBDx™ studies in India are currently under development and would include the evaluation of TBDx™ under LED lighting conditions, evaluation of the TBDxV™ decision support system for Ziehl-Neelsen staining conditions, and lastly, the development and evaluation of a fully-automated detection solution for Ziehl-Neelsen staining conditions.
- Potential strategic development agreement with a foreign entity that has developed a rapid slide scanning system. The discussions have only recently begun, and until we can inspect the system and determine its full capabilities we won’t know if there is value to our technology platform.
Revenue – will it ever happen?
The single most frequently asked question. While there are no guarantees that revenue will ever develop for TBDx™, there certainly are sound reasons for optimism. We have technological advancements that expand and dramatically improve upon a well understood diagnostic process, sputum smear microscopy. We have the determination, commitment and dedication of our employees who have advanced the technology and the testing forward in the face of economic constraints. We have the attention of leaders in the TB diagnostic arena. And lastly, we have competitive advantages over the molecular designed diagnostic applications, and in fact, TBDx™ may be the perfect complement in a layered diagnostic approach.
It goes without saying, the journey has taken longer than we all wanted, but nothing worthwhile comes without perseverance and sacrifice. Confucius said, “It does not matter how slowly you go, as long as you do not stop.” We have no intention of stopping!
Stay tuned as the future unfolds!