HERNDON, VA--(Marketwire - August 26, 2009) - 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.
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
About Guardian Technologies International
Airport Security: Guardian's technology compliments and enhances
current-generation baggage x-ray scanners with the ability to automatically
and effectively detect, locate, and identify explosives and other types of
threats.
Disease Identification: Existing medical imaging devices used in Computer
Aided Detection (CAD) are further improved with Guardian's auto-diagnostic
ability to detect anomalous tissue (e.g., tumors) and other potential
disease states or conditions.
Forward-Looking Statements
Statements included herein may constitute "forward-looking statements."
These statements are not guarantees of future performance or results and
involve a number of risks and uncertainties. Actual results may differ
materially from those in the forward-looking statements as a result of a
number of factors, including those described from time to time in our
filings with the Securities and Exchange Commission. The Company undertakes
no duty to update any forward-looking statements made herein.
