Guardian Technologies International, Inc. (OTCBB: 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.