HERNDON, VA, Jun 21, 2010 (MARKETWIRE via COMTEX) -- Guardian Technologies International, Inc. (OTCBB: GDTI), today announced that testing of the fully automated tuberculosis (TB) detection system, Signature Mapping TBDx(TM) (SM TBDx), at the South African National Health Laboratories (NHLS) successfully validated the integrated performance of each hardware component of the automated slide management system. The integrated hardware-software TB detection solution accurately identified 100% of the TB slides processed during an abbreviated trial that was delayed due to shipping and customs issues beyond Guardian's control.
In scheduling the clinical trial Guardian was well aware of the tight timeframe, which afforded no margin of delay due to the fact that critical South African personnel were scheduled to attend a weeklong national TB conference at the conclusion of our scheduled time, as well as other logistical challenges associated with the World Cup Games. Based on SM TBDx's speed of diagnosis and strong performance, a consensus was reached by South Africa's top TB experts on a new strategy to expand the scope of the clinical trial protocols to more fully understand and empirically demonstrate the full potential of the new integrated technology. The intent is to measure and demonstrate an even greater level of routine production sensitivity that would translate into the detection of more TB scanty cases, a major area of missed diagnosis responsible for increased incidence of disease.
The urgency to complete the clinical trial of SM TBDx was further amplified by a newly announced aggressive HIV/TB population screening program of an additional 15 million citizens by June 2011, approximately 30% of the population of South Africa. To address the urgency of the situation and to avoid the potential delays of adhering to strict governmental procurement processes, decisions were reached to employ an alternative contracting vehicle to expedite deployment.
Dr. Gavin Churchyard, Chairman of The Aurum Institute, states, "Signature Mapping TBDx is an exciting new technology that enhances sputum smear microscopy for TB by combining automated slide management and computer detection of the TB bacillus. This technology breakthrough provides for the first time, the opportunity to more thoroughly analyze sputum smear samples to find TB, particularly in the earlier stages of disease when the number of bacilli present on the slide are fewer and may be missed with conventional microscopy. Finding and treating patients earlier will help reduce the spread of the disease, while automating the screening process will provide fast and consistent results. TBDx holds the promise to screen large numbers of TB suspects in a cost-effective manner, find more cases of TB and to reduce the TB burden in resource poor settings."
"As South Africa prepares to expand HIV and TB screening to an additional 15 million people, the urgency to complete the trial and negotiate a business contract is that much more vital. Collectively we have agreed to a contract framework to support a maximum rollout, in a minimum amount of time," commented Dr. Dave Clark, Deputy Chief Executive Officer of the Aurum Institute. "The keys to success are a government procurement vehicle that expedites the purchasing process, and securing a financial partner to fund the acquisition of the required hardware procurement. As Guardian's newly appointed Reseller/Distributor, we believe that both goals have been met and we expect to execute the financing agreements over the next two months."
The collective judgment of the interested parties was that the clinical trial protocols should be expanded beyond the current plan to include comparative data, as follows:
-- human expert readers under research conditions -- human laboratory technologists reading under routine conditions -- SM TBDx (at 100 fields of view per slide, the WHO accepted guidelines) -- SM TBDx (500-1,000 fields of view per slide) -- culture (considered the gold standard)
The rationale for expanding the trials to include 500-1,000 fields of view per slide was the ability to conduct a more thorough analysis of the sputum smear and the potential implications for higher sensitivity and more rapid TB detection and verification than the six to eight weeks required for culture. Such a study is only possible because of the speed with which SM TBDx can process and diagnose a sputum slide. Every effort will be made to keep the clinical trial moving expeditiously and to mitigate potential problems such as shipping and customs delays or access to replacement hardware inventories. The parties have agreed that the TBDx trial should be moved to the United States and be conducted under independent observer validation. The selection of the independent observer, the dates to recommence the trials, and the protocols are being coordinated by the Aurum Institute and NHLS to facilitate an unbiased comprehensive trial. It is anticipated that the recommencement will begin by July 19th. "The new clinical protocols will establish higher standards of scientific credibility that will lead to greater international acceptance of SM TBDx. Further, when combined with the procurement and funding vehicles arranged by Aurum, the enhanced clinical trial should accelerate governmental approvals, drive increased revenue, and faster rollout throughout South Africa," stated Bill Donovan, Guardian's President. "The need for SM TBDx is present and growing. We intend to make a considerable positive impact on South African TB detection beginning in 2010."
About SM TBDx: In the first phase of clinical trials in Oct 2009, SM TBDx achieved 92% detection sensitivity and 3.75% false positive rate. The SM TBDx solution combines Guardian's 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 Guardian Technologies International: Guardian Technologies uses high-performance imaging technologies and advanced analytics to create integrated information management products and services. Currently, the company offers products and services for use in disease detection and airport security. By automating the processing of large quantities of graphic, numeric, and textual data, Guardian allows organizations to more efficiently detect, extract, analyze or effectively act upon the information. Guardian's solutions are designed to improve the quality and speed of decision-making and enhance organizational productivity and accuracy. Founded in 2003, Guardian is publicly traded on Nasdaq as GDTI. For more information visit http://www.GuardianTechIntl.com
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, trends in the markets, variations in the company's cash flow, competition, celebrity programs, 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.
CONTACT: For Guardian: Richard Borrelli +1 703-464-5495
Julie Shepherd of Accentuate PR +1 815-479-1833 Email Contact
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SUBJECT CODE: Computers and Software:Hardware Computers and Software:Software Government:International Pharmaceuticals and Biotech:Trials Medical and Healthcare:Healthcare Pharmaceuticals and Biotech:Equipment and Supplies Medical and Healthcare:Health and Nutrition
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