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Last updated on April 23, 2014 at 10:33 EDT

Guardian Technologies International Enters $2.5 Billion Worldwide Tuberculosis Pathology Market

August 7, 2008

Guardian Technologies International, Inc. (OTCBB:GDTI), announced today further developments in its Agreements with the Aurum Institute for Health Research in South Africa. Based on the broadly reviewed results of Guardian’s product prototype for sputum analysis, using Signature Mapping(TM) capabilities for the automated detection and quantification of Tuberculosis, Guardian has expanded its relationship with Aurum to include collaboration on product development and commercialization, as well as marketing and distribution rights in South Africa. It is anticipated that Aurum’s distribution rights will extend to additional automated pathology products developed as a result of this collaboration, as well as additional international markets. Aurum will be responsible for the marketing, sales, installation, training and ongoing customer support within its geographical markets.

Both companies agreed to collaborate in the further development of a full product suite for pathology, as well as fully automated imaging analysis systems for the early identification and quantification of tuberculosis, silicosis and other infectious and non-infectious diseases.

Using Signature Mapping(TM) technology integrated into a digital pathology workflow system will significantly improve diagnostic detection accuracy, reduce diagnostic processing time and lower the cost to analyze tens of millions of sputum microscopy specimens around the world for Tuberculosis. The strategic objectives outlined in the Agreement are inline with the guidelines and objectives of the World Heath Organization (WHO): (1) to promote and improve the performance of testing procedures, (2) to make testing procedures easier to complete and less expensive to operate, and (3) to bring diagnosis closer to the point of primary care(1).

“Improved diagnostics supports early detection, which translates into early commencement of treatment, one of the most powerful weapons against diseases such as TB,” says Dr. Dave Clark, Aurum’s Executive Director. “We believe that Signature Mapping(TM) will play a key role in the automation of early-stage diagnostics in several clinical and pathology settings. Our goal is to further develop and distribute Signature Mapping(TM), in tandem with Guardian, to help reduce labor costs, provide faster diagnoses and redirect scarce professional skill application in developing countries.”

WHO has declared tuberculosis a global health emergency and estimates that over 83 million sputum microscopy tests are performed annually at a cost to the worldwide health system of approximately $2.5 billion(2). Of that total cost, 80% of the disease occurs in 22 high-burden countries, including India, China, Indonesia, Nigeria, Pakistan, South Africa, and the Russian Federation. Microscopic sputum analysis is a labor-intensive and tedious process requiring trained technologists to analyze hundreds of glass slide samples per day, in a manual process that is prone to fatigue and human error. Even with these challenges, WHO guidelines clearly state that sputum microscopy is still the preferred field method for diagnosis of TB. With only 40% of TB accurately detected by microscopy, sensitivity improvements are needed to update the methodology while reducing the current analysis costs. Signature Mapping(TM) technology holds the potential to significantly improve the accuracy of diagnosis while lowering the cost and time to diagnose, all of which is critical to the treatment and management of TB.

Bill Donovan, President and Chief Operating Officer of Guardian Technologies International states, “We believe this collaboration is simply a perfect blending of technology and clinical science to save lives by advancing new technology products to the market. We have developed, beyond a doubt, a groundbreaking technology that we project could generate in excess of $200 million in revenues during the first thirty-six months of product introduction. It is our expectation that the product will be introduced in South Africa during the fourth quarter of 2008. The intangible benefit to this endeavor is that we get the opportunity to save lives and benefit all of mankind.”

“TB is an entirely treatable and curable disease, yet every four seconds someone becomes infected with TB and every ten seconds someone dies from TB. The world needs a better technology to quickly, accurately and cost effectively detect TB,” states Dr. Clark. “The moment we reviewed the results of Guardian’s Signature Mapping(TM) applied to a set of case studies we had provided, I knew we had found a basis for a new and better way of detection of TB – I am very encouraged by our initial results. Our success in this program will potentially revolutionize the diagnosis of TB leading to real time treatment in remote areas, where it could be weeks before test results would be determined by conventional methods.”

About Aurum Institute

The Aurum Institute for Health Research is an independent medical scientific organization for the treatment of and research into epidemic and other diseases in developing countries. The negative impact of the poor understanding and management of these epidemics is vast, affecting individuals, communities and economies. The recognition of the huge advantages of controlling these diseases is Aurum’s motivation.

Aurum has an international reputation for its work in the fields of tuberculosis, HIV/AIDS and is the recipient of research, awards and other grants from South African and international agencies and institutions.

About Guardian Technologies International

The impact of Guardian’s industry-first computer aided detection technologies are immediate and profound for helping to eliminate human error in both the Homeland Security and the Medical Industry sectors. The Company’s software solutions can be seamlessly installed to compliment existing imaging devices, such as baggage scanners and medical MRI, to scan the contents of any image and immediately identify items of interest not easily discernable by the human eye.

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.

Technology-Independence: Because Guardian’s technologies utilize and process the actual image output generated by the original imaging systems, virtually any existing or future imaging device can be upgraded with Guardian’s products, delivering an instant, multi-billion dollar potential customer base with no competition.

Forward Looking Statements

This news release contains forward-looking statements that involve risks and uncertainties. Forward-looking statements in this document and those made from time to time by Guardian through its senior management are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements reflect the Company’s current views with respect to the future events or financial performance discussed in this release, based on management’s beliefs and assumptions and information currently available. When used, the words “believe,”"anticipate,”"estimate,”"project,”"should,”"expect,”"plan,”"assume” and similar expressions that do not relate solely to historical matters identify forward-looking statements. Forward-looking statements concerning future plans or results are necessarily only estimates and actual results could differ materially from expectations. Certain factors that could cause or contribute to such differences include, among other things, in particular, the size and timing of contract awards, performance on contracts, performance of acquired companies, availability and cost of key components, unanticipated results from audits of the financial results of the Company and acquired companies, changing interpretations of generally accepted accounting principles, outcomes of government reviews, developments with respect to litigation to which we are a party, potential fluctuations in quarterly results, dependence on large contracts and a limited number of customers, lengthy sales and implementation cycles, market acceptance of new or enhanced products and services, proprietary technology and changing competitive conditions, system performance, management of growth, dependence on key personnel, ability to obtain project financing, general economic and political conditions and other factors affecting spending by customers, the unpredictable nature of working with government agencies and other risks, uncertainties and factors including those described from time to time in Guardian’s filings with the Securities and Exchange Commission, including without limitation, Guardian’s Form 10-K for the year ended December 31, 2007, and its quarterly reports on Form 10-Q. Guardian expressly disclaims any obligation to update any forward-looking statements.

(1) World Health Organization, Diagnostics for tuberculosis, Global demand and market potential, Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by UNICEF/World Bank/WHO

(2) World Health Organization, Diagnostics for tuberculosis, Global demand and market potential, Special Programme for Research & Training in Tropical Diseases (TDR) sponsored by UNICEF/World Bank/WHO