Whether the technology is routine or disruptive it can be received with considerable skepticism, especially if it result
s in a substantial shift to an existing paradigm. It is the nature of the scientific method to demand proof and repeatable results whenever new technologies are introduced. While the technological landscape changes, the basic questions remain the same. Explain the science behind the technology? How is it different from other similar technologies? Where has it been tested? How was it tested, and by whom? Was the data gathered from testing statistically relevant?
The scientific evaluation surrounding TBDx™ has been particularly arduous, for several reasons. First, unlike radiology where the use of digital imaging has been well-developed over the past 20 years, pathology laboratories, particularly those focused on infectious diseases, are just now beginning to see the potential of applying image processing to their work. Second, an understanding of the science behind image processing is in a nascent period for the professionals in the field. Being familiar with identifying TB bacilli by peering down a microscope is relatively foreign to the process of using detection algorithms to evaluate the pixels within a digital image. Lastly, laboratories turn most often to biomedical, chemical, and molecular sciences for answers. It fits within their comfort zone educational and professionally. It’s what they do day in and day out. Lying outside the typical laboratory sphere of knowledge, image processing science is not the first considered when seeking new diagnostic technologies.
Unlike developed countries where the use of medical technologies and diagnostic tools are closely evaluated and regulated by government agencies, developing countries have not always had in place the evidence-based standards needed to fully analyze the efficacy of deploying certain technologies. From time-to-time this has led to disappointing results and wasted investments. Over time laboratories and the agencies funding or subsidizing technology purchases became more skeptical of the claims made by commercial enterprises.
With the efforts of the World Health Organizations (WHO) this situation has steadily reversed. Much more money is spent on evaluating the performance of technology and measuring its impact on patient outcomes, thus generating the body of evidence needed to justify a purchasing decision. One such medical application is the TB blood test, which has been widely sold throughout the developing world. Recently WHO withdrew its approval of the technology due to its low rate of detection and high ‘false alarm’ rates. In actual fact, the evidence was showing that the test did not meet its claims and should not be used as a reliable TB test.
Global health organizations, like WHO, have established universal evaluation protocols that provide evidence-based data, independent of the technology manufacturer, upon which to measure the effectiveness of patient outcomes. As much as this information is needed to adequately and fairly evaluate technologies, it represents a significant hurdle for a small research and development company. At the very least, it extends development timelines and requires significantly more investment. Today’s healthcare protocols involve:
- Multi-country clinical evaluations.
- Funding in the range of $100k – $300k per clinical evaluation.
- A well-established and respected clinical partner whose work will be viewed as independent, thorough and scientifically defensible.
- Establishment of a well-grounded research protocol that addresses statistical relevance, ethical considerations and expected outcomes.
- The protocol outlines in detail the objective of the study, how diagnostic accuracy will be determined, what will be accomplished, the funding that will be required, the methodology and diagnostic standards that will be followed, the participants, statistical methods that will be used, and how the results will be reported.
- The protocol requires multiple reviews and revisions until finalized.
- The final protocol requires an Ethics Committee review from an internationally recognized organization.
- The protocol requires final approval by an Internal Review Board, generally a designated committee internal to the government agency or research organization.
- The study is then conducted, which may take up to six months or more to complete.
- The final results are distributed, and a final report is prepared for publication.
- The draft of the report is submitted to a peer review journal. The journal distributes the draft to multiple reviewers. The reviewers send in their comments and questions. These questions are answered by the authors. The draft is revised, finalized, and submitted to the publication, or it may be submitted as a paper to a medical conference where the results may be presented by the author.
- The cost of contracting for an independently prepared and reviewed publication can range from $10K to $50K.
- Drafting, submitting and reviewing the paper prior to submission generally takes 3-6 months.
- Publication generally takes 6 -12 months after receipt by the journal, wholly dependent upon the number of issues created per year and the backlog of publications.
The entirety of the above process is essential for the validation not only of TBDx™, but also any additional applications that the Company introduces to the marketplace, and there are many applications to be layered on the existing automated laboratory platform.
Expedite revenue generation, why publish?
Purchasing decisions are heavily influenced by published literature in respected medical journals. Published research is trusted as objective evidence and is relied upon if the study methodology is sound. Journal articles are the very first piece of information requested by any prospective purchaser, and they establish the scientific evidence for technology performance. Without this independent scientific evidence, the ability to generate revenues is non-existent.
NOTE: We took a good deal of time in determining how much information to provide above. We have provided a lot of information because it is important that our shareholders understand the lengthy process that we simply refer to in our information releases as clinical studies or evaluations. Given the number of clinical studies that may be ongoing at any point-in-time, they will be at various stages of completion. Our communications on these studies will mean much more if you understand the process and implications with respect to the time required for completion.