Each year the Stop TB Partnership, and its New Diagnostic Working Group, host an open half-day meeting to discuss the development of new TB diagnostics. The meeting arrays a list of promising technologies that are in the evaluation pipeline. This year’s list included products focused on gene sequencing, protein bio-markers, the use of lipids, a multiplex bio-chip (lab-on-a-chip), and for the first time, automated sputum microscopy.
At a time when funding for global health initiatives is increasingly tighter, and budgets dedicated to infectious diseases are far smaller, focusing on automated sputum microscopy acknowledges the difficult economics of the laboratory environment today. High technology diagnostic solutions, especially those based on bio-markers and gene sequencing will require time to fully develop and be evaluated. When that occurs, it is still expected that their diagnostic costs may be too expensive to be scaled-up and widely deployed in countries suffering the greatest disease burden.
Focusing attention on automated sputum microscopy acknowledges that the technology is well researched, well known, and frequently used in disease-burdened countries. It is a more affordable technology. Automating this process, by using image analysis science to “see” what is missed by human vision, can deliver considerable benefits. It can more consistently identify the most likely TB positive cases, which should progressively reduce TB transmission rates. Additionally, it can be widely deployed as a replacement for routine microscopy.
During the half-day presentations, three specific Automated Sputum Microscopy technologies were noted in the diagnostic “pipeline,” either in development or in evaluation. TBDx™ was acknowledged as the technology most ready for use having been evaluated in South Africa and Nigeria. Two additional evaluations, sponsored by the Foundation for Innovative New Diagnostics (FIND) were underway in Lima, Peru and will be underway soon in Vietnam. Our technology is seen as having essential utility in laboratories with high slide volume requirements, in supporting quality assurance programs that often lag because of insufficient staff needed to recheck slides, and in monitoring the progress of drug therapies in TB patients.
The two additional technology companies and their principals are well known to our company and are well regarded. All three companies have designed their automated technology approach to address specific market niches where unique and affordable diagnostic value can be delivered.
In our next series of blogs we will be reporting our observations and insights that were obtained from the meetings and presentations during the 45th World Union Conference on Lung Health, recently held in Barcelona, Spain. We will report on the latest in Target Product Profiles, developed by WHO / CDC / FIND and others, intended to guide developers in their product development. We will report on the latest in prevalence surveys, an effort to gain a clearer picture of TB burden throughout the world. Lastly we will report on research and operations that will show where TBDx™ can be best targeted and successful.