Guardian Technologies International meets and presents SM TBDx to Indian healthcare officials

Tuberculosis (TB) continues to be a serious global pandemic health threat with more than 9 million new cases diagnosed annually. TB is a leading cause of mortality in India, killing nearly 1,000 people each day. During October 2009, Guardian Technologies International (OTCBB: GDTI) was invited by the Government of India to meet and present Signature Mapping TBDx™ (SM TBDx) to senior government healthcare officials and scientists. Of prime importance were the beneficial implications that SM TBDx could potentially provide as a diagnostic solution to improve TB detection and stem the country's TB epidemic.

Guardian presented to a very distinguished group including: the Secretary of the Ministry of Science and Technology; the Secretary of Health Research; the Deputy Director General of the Ministry of Health and Family Welfare; and, the Director General of the Indian Council of Medical Research (ICMR). As a direct result of these presentations, as well as meetings with three of the Regional Laboratory Directors responsible for healthcare research and implementation within India's decentralized program for TB control, India's healthcare officials requested a detailed proposal to fund the migration of SM TBDx. The delivered proposal is intended to both accommodate the Indian laboratory protocols and to provide a fully automated diagnostic system, from automated slide handling to image capture to case level analysis.

"Guardian's Signature Mapping TBDx system provides a very promising solution to the labor-intensive task of diagnosing TB," said Dr. N.K. Ganguly, Advisor to the Health Minister, Ministry of Health and Family Welfare, a distinguished biotechnology fellow and advisor at the Translational Health Science & Technology Institute, and the former Director General of ICMR. "Based upon our discussions, the SM TBDx demonstration, and information shared in our meetings, I am hopeful that it can be applied in India, as well as other impacted countries. We are reviewing Guardian's Pilot and Clinical Study Proposal for consideration to move the program forward."

Dr. Ganguly also plans to incorporate a technical review of Guardian's SM TBDx system in a forthcoming whitepaper reviewing new TB diagnostic technologies and their potential impact on the global TB healthcare challenge.

"Our meetings could not have gone any better. We were most fortunate to garner the interest of very highly placed government healthcare officials, who quickly embraced the concepts of the technology and were able to envision India's TB diagnostic program in the future," stated Dr. Krishna Banaudha, Biochemistry & Molecular Biology, The George Washington University - School of Medicine, and Guardian's India Advisor. "At the clinical laboratory level, I was impressed by the creative ideas that were generated around the technology. Signature Mapping TBDx certainly provides an impressive platform for next-generation laboratory research."

With more than 37.8 million patient slides processed annually, and with each slide having up to 100 fields of view (FOVs) to analyze, India is the world's largest diagnostic reviewer of TB sputum slides, utilizing approximately 13,000 laboratories. The SM TBDx system is an automated diagnostic solution using sophisticated detection algorithms to identify TB. SM TBDx's greatest advantage is its ability to quickly screen patient samples, more consistently and efficiently than laboratory technologists. It holds the potential to significantly reduce the number of cases requiring review by trained technologists. In India alone, it could eliminate more than 10 million case reviews and more than one billion manual FOV reviews. The benefits are faster, more consistent and more accurate TB diagnosis and increased productivity of existing resources, which leads to quicker treatment, and ultimately slows the pandemic spread of the disease.

Mr. Donovan further stated, "Globally, TB is the world's second leading cause of death from infectious disease with more than US$ 1 billion being spent annually on TB diagnostics. Due to its extremely high burden rate, the Government of India maintains one of the world's largest and most aggressive campaigns against TB. The proposed Signature Mapping TBDx project to migrate the technology to the Ziehl-Neelsen staining method will improve India's diagnostic results and improve productivity in a cost effective manner that can be replicated in other heavily impacted countries."