TBDx and Its Fit in the World of TB Diagnostics

A View from 35,000 Feet

TBDx™ revolutionizes the 105-year old TB sputum microscopy diagnostic process. It creates an innovative diagnostic paradigm that augments the almost symbiotic relationship between a human and computer technology. By integrating state-of-the-art digital image processing science and leveraging the embedded technology (microscope), a novel diagnostic platform emerges for the 21st Century.

Over the past five to ten years there have been international research and development initiatives aimed at the production of new diagnostic tools for the detection of TB.  These initiatives arose from: (i) the under-performance of smear microscopy as a diagnostic tool; (ii) a desire to eliminate human factor errors from the diagnostic process; and (iii) the need for faster and more accurate diagnostic results.  While several new and promising technologies have been developed and introduced to the international TB community, experts continue to believe that smear microscopy will remain the primary TB diagnostic tool into the foreseeable future.  Their rationale is predominantly driven by economics. TB is often prevalent in those areas of the world with high population concentration and low per capita income.  The cost of these new diagnostics exceeds the country’s ability to economically support a mass deployment.  The rise in laboratory operating costs may be 10 – 20 times above their current operating expenses, due to the high cost of consumables.  This is a financial burden most countries cannot absorb, even with international subsidies.

This is why we believe TBDx™, when clinical evaluations have been completed, will be the preferred choice for first-tier TB screening.  Few adjustments are needed to existing laboratory protocols to implement TBDx™. It requires neither special power systems nor specified operating temperatures to remain effective.  Further, TBDx™ uses smear microscopy, an extremely well-understood diagnostic medium as its basis. Through automation, human involvement is minimized on slide management, patient data recordation, and diagnostic decision-making.  Each slide is analyzed in approximately two minutes and the diagnostic results are immediately available to a user-defined distribution list.  Just as importantly, the cost of TBDx™ fits within the current laboratory financial operating structure.  Laboratory technicians (approximately four techs to handle 200 slides per day) previously assigned to read smear slides can be reassigned to other laboratory procedures that may have greater impact and less tedium.

We believe that the newly developed diagnostic technologies have an essential role to play in TB diagnostics and, more importantly, represent a complimentary technology to TBDx™ that will strengthen the diagnostic accuracy and timeliness of TB detection.  Utilizing a layered diagnostic approach, with all TBDx™ positive cases being secondarily screened by one of the new technologies or culture, laboratories will reduce the number of TB cases undiagnosed and lower their cost per positive diagnosis.  This will lead to earlier treatment and fewer opportunities for the disease to be transmitted to other healthy individuals.

Since cost has been an inhibiting factor for molecular diagnostics, validation of a layered technology approach could accelerate adoption of these diagnostic technologies as second-tier case confirming solutions.

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