TBDx™ Evaluations Ready for Journal Publication and Nearing Completion

Applied Visual Sciences, Inc. (APVS.OB) – March 30, 2015 – Leesburg, Virginia

As is true with the introduction of any new TB diagnostic technology today, gathering scientific evidence of its routine performance is a necessary step towards endorsement and acceptance within a healthcare system. Oftentimes these data are gathered from evaluations conducted by interested health care systems or through the collective work of independent scientific organizations.

These evaluations not only follow strict procedural protocols, but also the results are subjected to unbiased scrutiny from industry experts, and often lead to peer-reviewed scientific publications. Evaluations advise prospective users on the performance characteristics of the technology, guide how best to use the technology within their laboratory process, and provide the technology developer with insights into performance and operational characteristics.

For the past few years TBDx™ has been a part of several technology evaluations. Three such evaluations have been completed, and two evaluations are nearing completion. We thought our readers would welcome an update on our progress.

South Africa

Two evaluations have been completed by the Center for Tuberculosis. In 2011 a “proof of concept” evaluation led to the conclusion that TBDx’s™ automated sputum microscopy could be a viable alternative to routine smear microscopy. With improvements in the algorithm, TBDx™ could be used as a stand-alone diagnostic, or could perform in tandem with another diagnostic test. PLOS ONE, the Public Library of Science, an open access peer-reviewed scientific journal, published these results.

In 2013 the evaluation focused on the potential of TBDx™ to be used as a triage or “rule-out” TB test where positive cases could be confirmed by a more specific diagnostic test. A high-level presentation of the 2013 evaluation results was described during the 2013 Union World Conference on Lung Health.

The team of industry-leading evaluators have organized the final results of this recent evaluation into a manuscript and submitted it for publication to the American Journal of Respiratory and Critical Care Medicine (AJRCCM). The working title of the manuscript is Performance of a novel algorithm using automated digital microscopy for diagnosing tuberculosis. The twice-monthly AJRCCM is a peer-reviewed medical journal of the American Thoracic Society. The manuscript has been reviewed and is likely to be accepted for publication following the modest edits that were requested. According to the AJRCCM website “officially accepted articles are posted within 48 hours; print versions are posted within 2 months.”.

This second published evaluation continues our effort to present clear and convincing scientific evidence of the performance characteristics of the technology. A follow-on article is expected later this summer when the current authors present an analysis of the economic impact of TBDx™ as a sole diagnostic test, and as a “rule-out” triage test where TBDx™ positive cases are confirmed by GeneXpert.

Nigeria

Under the direction of the Liverpool School of Tropical Medicine, the National and FCT Tuberculosis and Leprosy Control Programs, and the Zankli Medical Center in Abuja, the preliminary performance analysis was presented last October during the 2014 Union World Conference on Lung Health. TBDx™ slide processing completed prior to the end of the year; however, the corresponding culture tests were not finalized until last month. The complete results are now under review by the primary investigators and we are told that a review of these data should be available at the end of March, or the early part of April. The intent is to submit the evaluation results to a scientific journal for peer review and publication, likely in May.

Based upon the interim results, we anticipate the performance results will be similar to the performance of a highly experienced laboratory microscopist, though not as high as results from South Africa. This is the first time TBDx™ has evaluated direct sputum smears, and industry research evidence shows that detection rates are lower in direct smears than their concentrated sputum smear counterparts (such as what was used in South Africa). Additionally, TBDx™ processed one slide while the microscopist examined two. The published research comparing the detection rates when using one or two slides always shows that detection rates are higher using two slides.

Peru and Vietnam

Last Spring we entered into a Cooperation Agreement with the Foundation for Innovative New Diagnostics (FIND). FIND is well regarded as an objective evaluator of new diagnostic technologies. In exchange for providing our TBDx™ technology to the evaluation sites, FIND agreed to develop the necessary study protocols and test TBDx™ using their laboratory network of approved hospitals and clinics. Evaluations were scheduled for Lima, Peru and Ho Chi Minh City, Vietnam. The intent of the evaluations has been to measure the performance of the technology and learn more about its operational characteristics. Most importantly, it represented an evaluation that included both direct and concentrated sputum smears, hoping to identify and measure any performance differences between the two smear types.

TBDx™ processing has been completed in Lima. The culture tests have been completed and the data are being collected and analyzed by the FIND staff, for each type of smear. All results will be compared against culture, the gold standard, and each case seen by TBDx™ will have a corresponding molecular test, and a routine microscopy read.

Today, TBDx™ is processing cases in Ho Chi Minh City and should finish in the first week or two in April. The results can be tabulated and compared quickly as the culture tests for each specimen have been completed. Both evaluations use exactly the same testing protocol so all results will be compared against culture, and will include direct and concentrated smears, and routine microscopy and molecular testing.

It is our understanding that FIND intends to complete all of the analysis for internal presentation in May.

Final Comments

In the weeks ahead we will release additional performance results as they become publicly available. Each of these evaluations are independent of the company. We provide the technology, but the study, it’s funding and the data with all of its written analyses, belong to the sponsoring organizations or to the journal publisher. For example, we have known the details behind the South Africa evaluation, but have only released what has been made available to the public so far. When the published article appears, and is posted on the blog, you will see a great deal more details and you may notice that APVS is not among the cited authors, appropriately so.

We genuinely appreciate your patience with the process. These efforts involve talented and dedicated scientists at work, focused on the fair and accurate evaluation of new diagnostic technologies that may lead to earlier disease detection and better health outcomes. Truly the emphasis always remains on precise and accurate analysis.

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