Guardian Technologies International, Inc. (/exchange>OTCBB/exchange>>/>: GDTI) today announced that its Software Quality Assurance Team has completed all unit, component, integration, and systems tests of Signature Mapping TBDx™ (TBDx™) in preparation for September clinical trials in South Africa. Under rigorous internal performance testing of 740 sputum slides, TBDx processed each slide in minutes while maintaining a consistently high bacilli detection level of over 90%, with false positives of less than 3%. In a global environment where sputum microscopy detection is only 20%-60% accurate and final results can take up to eight weeks, TBDx represents a diagnostic transformation towards automated detection of tuberculosis (TB). Further, the Signature Mapping platform can potentially be applied to all laboratory diagnostic procedures (i.e. malaria, leprosy, HIV, etc.).
TBDx began with one objective: automate the process of TB diagnosis and eliminate the human factor limitations associated with routine sputum microscopy. Accomplishing this objective, Guardian overcame vast extremes in slide quality, stain penetration of the acid-fasting bacilli, and differing regional staining techniques. February 2009, Guardian completed and delivered to South Africa a working prototype for initial evaluation. Based on the successful performance of the prototype, Guardian entered into a Memorandum of Understanding with the South African National Health Laboratory Services (NHLS) in March 2009, and in cooperation with our clinical partner, The Aurum Institute for Health Research, Guardian has enhanced the application's performance and customized it to meet the diagnostic and quality management requirements of NHLS. TBDx is a robust and accurate automated diagnostic tool, with highly consistent performance and increased slide throughput, in a flexible software application that can be adapted to both rural and regional laboratory settings.
In April 2009, Guardian formed a medical advisory board of South African luminaries to assist in the development of specific global requirements and to advise on issues related to the detection of TB. "The members of this advisory board represent some of the best minds in medicine, specifically infectious diseases, and have provided invaluable advice and guidance. Each member brings the scientific, clinical and academic guidance that has significantly advanced our knowledge base on both the challenges facing TB detection, and the opportunities for the greatest advancements," stated Michael Trudnak, Guardian's Chief Executive Officer. The advisory board consists of: Dr. Gavin J. Churchyard, Thibela TB Principal Investigator; Dr. Gerrit Coetzee, Head of the National TB Reference Laboratory, NHLS; Dr. Bernard Fourie, Chief Scientific Officer, Medicine in Need; Dr. David Clark, Chief Operating Officer, Aurum Institute; Mr. Stan Harvey, Business Manager, Executive Regional Manager, NHLS; and, Dr. Natalie Beylis, Director of Laboratory TB Services, Braamfontein Hospital, NHLS.
Completion of TBDx is an achievement that fittingly reflects the Company's mission statement, "To Save Lives." Michael Trudnak stated, "We are very excited to be joining the global fight to stop the spread of TB. We are very pleased with the application's level of performance, which far exceeds our original design goals. Stress testing of TBDx with the South African National Labs will provide a tremendous opportunity to test all aspects of our system on large slide volumes. The National Labs conduct over four million sputum tests per year and will establish the benchmarks by which we will expand to the rest of the highly infected countries of the world."
TB is a pandemic worldwide challenge, further complicated by strains of drug resistant TB, which are being detected with increasing frequency. One-third of the world's population is infected with TB and up to ten million new cases are diagnosed worldwide annually. Someone dies from the disease every 20 seconds, accounting for approximately 2 million deaths annually. The World Health Organization annual estimates indicate $1 billion is spent annually to diagnose TB. To find out more information about the TB pandemic go to: http://www.who.int/mediacentre/factsheets/fs104/en/index.html
Guardian Technologies International, Inc.