Encouraging Results Continue to Emerge from TBDx™ Evaluation

One very important hallmark, in any technology evaluation, is the ability to consistently produce similar results across multiple independent tests. Can the performance of TBDx™ in external laboratory tests match its’ performance during internal tests?  Can this technology play a role in TB diagnostics? We asked Dr. David Clark, Deputy CEO of the Aurum Institute,  one of the collaborating institutional researchers, if he could provide his impressions of the study results to-date. Here are his thoughts:

Researchers working with APVS set out to evaluate performance of the system in a high volume setting against the ‘gold standard’ of organism culture. The evaluation aimed at investigating the performance of TBDx™ as a diagnostic, but also the possible impact of using TBDx™ as a front-end screening application to other diagnostic modalities.

Use of TBDx™ on over 1,100 sputum specimens from a high volume setting, together with matching organism culture results, has been completed and data is in the process of being cleaned and finalized. This data will enable credible measurement of the sensitivity and specificity of TBDx™ in high volume settings and provide important input to an economic analysis model being developed by leading TB modeling scientists in the field.

Preliminary calculations on the data thus far are particularly encouraging and researchers from South Africa and the USA are engaged in finalizing their investigations with a view to publication, as soon as possible.

From October 30 to November 3, 2013 the 44th World Conference on Lung Health will be held in Paris, France. This is the industry’s premier educational conference where new research findings are announced.   An effort is underway to submit an abstract, by the end of July, of the evaluation results for consideration in the “Late Breaker” session.  The session will feature a panel presentation on the latest in diagnostic research results.  This is a very competitive process, with hundreds of abstracts submitted for consideration.  We are hopeful the abstract will be accepted.

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2 Responses to Encouraging Results Continue to Emerge from TBDx™ Evaluation

  1. Albert Pickeral says:

    Please explain the idea of using TBDx as a front end application for use with other diagnostic applications ? Why the need for other applications ?

    • APVS says:

      Molecular technologies, such as GeneXpert, not only are capable of diagnosing TB consistently and accurately but also testing for drug susceptibility. However, TB laboratories have been slow to adopt the technology because of the strict operational requirements and because of the expense of the hardware, cartridges, and reagents. As you might imagine, these healthcare systems have not been immune to the global economic slowdown. Budgets are severely constrained, making the scale-up of new TB diagnostic technologies less affordable.

      The purpose for the TBDx evaluation is to determine how well the performance compares with routine microscopy. Does it identify TB cases and classify them accurately? If the performance is better than routine microscopy, can TBDx be deployed as a less expensive “screening” technology on the front-end of a two-stage diagnostic process?

      Rather than test all TB suspects using an expensive molecular technology, can TBDx perform as a less expensive initial test, screening out the 85%-90% of cases that are negative, at a lower cost? If it can perform as a screening technology, and send to GeneXpert ONLY the most likely TB positive cases, the cost savings will be substantial to the healthcare system. The preliminary results of the evaluation indicate TBDx can perform this role successfully.

      The combination of TBDx and GeneXpert leverages the strength of each technology. TBDx can identify the most likely TB positive cases and screen out the TB negatives cases. GeneXpert can confirm TB positive cases, remove false positive cases, and test for drug susceptibility. Together the two technologies can offer a substantial cost reduction to the healthcare system.

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