December 22, 2010 - 2:21 PM EST
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Highly Successful Clinical Trial Results Advance Signature Mapping TBDx Solution to Operational Evaluation in South Africa
Highly Successful Clinical Trial Results Advance Signature Mapping TBDx Solution to Operational Evaluation in South Africa

Dr. Gerrit Coetzee, Head of the National TB Reference Laboratory, stated, "If TBDx clinical trial results, on the remaining studies, continue to demonstrate this measured detection performance it will certainly have a major impact on the detection of TB in South Africa. The automated system and supporting data are very impressive. TBDx will vastly improve diagnostic performance, resulting in faster medical attention for the patient. This speaks directly to saving more lives and reducing the growth rate of TB."

The independently prepared and analyzed clinical data was presented to a panel of South African TB experts, including the top executives at the South African National Health Laboratory Services (NHLS). "The study used slides from a well characterized group of patients detected through symptoms and chest radiographic screening. The performance characteristics suggest that the TBDx technology may have an important public health benefit by detecting more TB cases sooner, thereby interrupting TB transmission," stated Dr. Dave Clark of the Aurum Institute.

In addition to demonstrating the fully automated 200-slide TBDx system, Signature Mapping Medical Sciences presented the full analytical details of the intermediary clinical trial to a panel of leading experts in the field of TB detection.

The panel included:

  • Sagie Pillay -- CEO of NHLS
  • Dr. Wendy Stevens -- NHLS Director of Clinical Programs, Infectious Diseases
  • Dr. Gerritt Coetzee -- Head of the National TB Reference Laboratory
  • Dr. Bernard Fourie -- Director of the Medical Research Council of South Africa, Chief Scientific Officer of Medicine in Need, and Extraordinary Professor in the Dept. of Medical Microbiology at the School of Health Sciences - University of Pretoria
  • Dr. Hendrik Koornhof, Emeritus Professor of Microbiology -- University of the Witwatersrand and Advisor to NHLS on infectious diseases
  • Dr. Gavin Churchyard -- CEO of the Aurum Institute
  • Dr. David Clark -- Deputy CEO of the Aurum Institute

The following preliminary statistical data represents intermediate clinical trial results:

  • TBDx is exceptionally sensitive, with high predictive values on non-scanty positive and normal cases;
  • TBDx was 74% more sensitive than the highly experienced microscopist;
  • Microscopist sensitivity improved by 25% when presented with fields of view from potential scanty cases. By comparison, the World Health Organization recommended the use of LED microscopes based upon approximately a 10% increase in microscopist sensitivity;
  • TBDx had low specificity on potential scanty cases (between 1 and 4 potential TB bacilli);
  • Specificity improved markedly when the positive fields of view, on those potential scanty cases, were reviewed by a microscopist.

Given TBDx's operational flexibility, NHLS will determine the various workflow configurations and the number of digital images to be collected under various clinical detection scenarios prior to operational deployment. In support of NHLS procurement requirements, TBDx will be installed at one additional laboratory to move the technology through the required "demonstration project" stage.

With the South African government's plans to screen approximately 15 million citizens for HIV and TB it is critical to find a low-cost, high-performing, and fast method for screening and diagnosing TB, with high sensitivity. Without an improved methodology the laboratory system will be stressed beyond its current capacity, and the potential for misdiagnosing TB cases amongst co-infected patients will be high. Post-completion of the clinical trial and the demonstration project, Dr. Coetzee has projected that NHLS will issue an order for approximately six 200-slide TBDx systems and 40-50 scaled down 8-slide automated systems. These systems will be deployed in a regional environment and used to determine the full extent of NHLS's system-wide requirements.

The panel agreed that sputum microscopy will not be replaced in the near future by any other detection technology, principally due to cost and speed issues. The much publicized DNA analysis system is currently undergoing clinical trials and evaluation at NHLS, and it is the belief of the panel that TBDx is every bit as sensitive as the DNA system, but without the specificity problems associated with the DNA system.

Dr. Churchyard stated, "I'm excited to say that the TBDx preliminary clinical results are promising and of critical importance to the worldwide fight to detect and control TB. The data suggest that the combined utilization of the laboratory microscopist and TBDx is a more sensitive approach to quickly identify TB, especially in difficult to analyze cases. TBDx holds the promise of providing the world with a cost effective screening tool capable of identifying greater numbers of TB positive cases. The remaining clinical trial must be completed quickly, and the results published so that the scientific community can understand the technology's contribution towards the search for a low-cost TB screening device. I would expect that the completion of the clinical trial will definitely demonstrate that TBDx should be moved into laboratory operation as expeditiously as is feasible."

About TBDx
The SM TBDx solution combines Applied Visual Sciences highly sensitive and specific image analysis software with an automated slide loader capable of processing 200 slides without human intervention, a bar code reader, an automated microscope stage navigator to process the slide through the capture of 100 fields of view (FOV), and an auto-focus camera to digitally capture each FOV. SM TBDx Manages and synchronizes the hardware components for hands-free slide acquisition and TB detection analysis. A video of the TBDx automated solution is available at the following link:

About National TB Research Laboratory
The NHLS forms a national network of integrated pathology laboratories throughout the country that utilize common laboratory management systems and transport networks to facilitate transport of specimens, referral of tests to reference laboratories and delivery of results. Approximately 265 laboratories are included in the NHLS, employing about 6,500 people. Their activities comprise diagnostic laboratory services, research, teaching and training, and production of sera for anti-snake venom, reagents and media. All laboratories provide laboratory diagnostic services to the national Department of Health, provincial hospitals, local authorities and medical practitioners.

About Aurum Institute
Aurum Institute, a leading international research institute in South Africa committed to the detection and treatment of HIV, malaria and tuberculosis. Aurum has received many international awards for their work in HIV, TB and malaria. Aurum's research has been funded by the Gates Foundation, The World Health Organization, CREATE, various South African mining companies and the South African Government.

About Applied Visual Sciences, Inc.
Applied Visual Sciences, Inc. is the holding company and IT development organization for subsidiaries specializing in high-performance imaging analysis technologies and advanced analytics for automated recognition of targets of interest. Applied Visual Sciences' subsidiaries include Guardian Technologies International, Inc., a homeland security/defense technology entity, and Signature Mapping Medical Sciences, Inc., a healthcare technology entity. The company is quoted on the OTC Bulletin Board under the symbol APVS.

Safe Harbor statement under the Private Securities Litigation Reform Act of 1995:
Statements in this news release looking forward in time involve risks and uncertainties, including the risks associated with the effect of changing economic conditions, capital raising activities, trends in the markets, variations in the company's cash flow, competition, business development efforts, technology availability and cost of materials and other risk factors. Factors that could cause actual results to differ materially are discussed in the Company's most recent filings with the Securities and Exchange Commission.


For Applied Visual Sciences:
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+1 703-464-5495

For Signature Mapping Medical Sciences
Richard Borrelli
+1 703-464-5495

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