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
"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
SOURCE: Guardian Technologies International, Inc.