Since our last trip to South Africa much has changed. The physical changes were easy to see. From the exterior physical appearance of the laboratory to the organization of the laboratory’s interior layout it was easy to recognize the intent of the new administration to change the environment and the operating culture of the national TB program. Today a new Director, Dr. Nazir Ishmail, spearheads these changes, directing the efforts of the newly renamed Center for Tuberculosis. Youth and change are powerful organizational combinations, oftentimes challenging operational norms, embracing new processes and technologies, and introducing renewed vitality and optimism. Truly it is a new day at the Center.
Two weeks ago we met with several new pathology professionals at the Center for Tuberculosis, one of several Centers now organized under the National Institute for Infectious Diseases (NICD). We were afforded the opportunity to present to the new Director and several new staff members the TBDx technology and the results of an internal 181 patient case study. This was their initial exposure to our automated smear microscopy detection system.
Their impressions of the technology demonstration were: (i) surprise that the challenge of automating the smear microscopy process had been accomplished; (ii) interest in the performance characteristics of TBDx and its potential for offering a more cost-effective diagnostic solution; (iii) interest in determining the impact of combining TBDx with a secondary diagnostic solution to provide the highest potential sensitivity and specificity; and, (iv) an understanding of the nature of the technology and its potential use in the detection of malaria, and other infectious disease detection.
Over the past year NICD has been deploying molecular testing (GeneXpert) to laboratory centers. Many of the people with whom we had meetings have been closely involved with molecular technologies and were very familiar with their performance and economic characteristics. Time and again a theme emerged in our discussions. No single TB detection technology represents a silver bullet. Each has its strengths, weaknesses, and cost implications. The question that was raised most often focused on combining technologies. The unanimous hypothesis was that layering the best individual technologies would produce faster and more accurate diagnostic results, at the most affordable cost. Their interest is in determining how TBDx can identify the most probable positive TB candidates that can be selected and directed to a second technology for confirmation and drug-susceptibility testing.
This theme was especially pronounced in a meeting with Dr. Ishmail, Dr. Michael Kimerling (Senior Program Officer in Tuberculosis for the Bill & Melinda Gates Foundation), and Dave Clark, Deputy-CEO of The Aurum Institute. Dr. Kimerling had previously requested a demonstration of the TBDx technology following a presentation, on the results of the TBDx clinical trial, by Gavin Churchyard, CEO of The Aurum Institute. Dr. Kimerling was especially interested in the results of our recent internal testing and, following a presentation illustrating the per-positive case cost advantages of using TBDx to select the most probable candidates remarked, “the combination with Xpert could be a game-changer if the TBDx performance could be further tested and evaluated.” He expressed a continuing interest in being kept informed of the plan the Center will create to further test the TBDx/Xpert combined technologies.
The five days in South Africa were well-spent, producing important insights and next steps:
- The Center expects to launch in late May or early June a two-year, nationwide research survey on Drug Resistant Tuberculosis. They intend to use cases from this larger survey to accumulate performance data (likely a few thousand cases) on TBDx. The study objectives will be to determine performance, by itself, together with a microscopist, and in combination with other molecular technologies such as GeneXpert and PCR.
- Until the study is launched and the study protocol for TBDx has been approved, the Center will provide additional TB slides to APVS for further internal evaluation.
- Though the study will employ the existing TBDx technology (FM with mercury vapor light source), the Center permitted us to return home with an LED adapter that will help us further examine the performance of our algorithms using an LED light source.
- Later this month a collection of staff members from the Center, Aurum, and APVS will conduct a conference call to discuss the protocol for the upcoming study. Based on successful outcomes from the study, TBDx will be installed in a minimum of two regional laboratories to gather operational research on functionality under routine laboratory operations. Data and information gathered from the operational study will be used to determine how TBDx can be most effectively deployed.
- There were at least two discussions held on how this technology platform could be used for multiple purposes. Two in particular were malaria detection and for automation of sperm counts. Our hardware-software automation platform delivers digital images acquired from a stained slide to a workstation where multiple algorithms could be created and operated for a range of diagnostic applications. This has been a concept we have reiterated on many occasions.
- Last but not least, we took the opportunity to upgrade the TBDx system at the labs. This new version has been developed and optimized for the Windows 7 environment. New features include a revamped and much more operator-friendly graphical user interface with controls designed for a touch screen. Processing slide times have been drastically reduced to an average of two minutes a slide using a 100 FOV acquisition matrix. A new Quick Review application has been added, allowing an operator to review a case in seconds.
You can see the new generation taking their place in the lab. The older generation is retiring and youth is coming forward. They understand technology, they understand pathology, they are interested in building a world-class pathology center, and are not interested in waiting. It is their time for leaving their mark on infectious diseases. They see this moment as the best time to evaluate TBDx to see if it can be a “game changer” in South Africa. We could not agree more.