Guardian Technologies, Inc. announced earlier this morning that they have received their first order from the South African National Health Laboratory Services for three of their fully automated Signature Mapping Tuberculosis Diagnostic (TBDx™) systems. The orders are slated to be shipped at the end of April in preparation for the final clinical evaluation of the TBDx fully automated detection system that will begin in May 2010.
TBDx is an automated diagnostic solution using sophisticated detection algorithms to identify tiberculosis under microscopy in sputum samples at the laboratory level. One of the benefits of this procedure is that it eliminates the majority of the human factor for errors. It also eliminates some of the tedious components of testing as it uses a fully automated slide handling system capable of continuously processing 200 slides without the need for human intervention.
Sensitivity and specificity results from Phase I clinical trials that were concluded in December 2009 were very encouraging, exceeding 92% against present microscopy methods, which yield much lower detection rates. The system also has been proven to produce a low false positive rate. The breakthrough application significantly advances the efficiency, accuracy, consistency and speed of TB diagnosis by microscopy.
Guardian, based in Herndon, Virginia, has specific goals for the Phase 2 testing:
• confirm the initial clinical results obtained in October 2009 utilizing the auto-focus integrated microscope and camera capability
• measure the operational efficiencies and potential cost-savings of fully automated operations
Upon confirmation of results during this final testing phase, the TBDx systems will be relocated to the South African National Health Laboratory Services laboratories most heavily involved in ongoing tuberculosis research.