HERNDON, VA--(Marketwire - December 01, 2009) - Guardian Technologies
) is bringing the diagnosis of tuberculosis
(TB) into the 21st century with Signature Mapping TBDx™ (SM TBDx), an
automated diagnostic solution using sophisticated detection algorithms to
identify TB under microscopy in sputum samples, at the laboratory level.
Signature Mapping TBDx successfully concluded the Phase I clinical
evaluation at the South African National
Health Laboratory Service's
(NHLS) Recheck Program, and has been
invited to return for Phase II (Final Phase) clinical trials in early 2010.
Sensitivity and specificity results from Phase I are very encouraging,
exceeding 92% against present microscopy methods, which yield much lower
detection rates. The breakthrough application significantly advances the
efficiency, accuracy, consistency and speed of TB diagnosis by microscopy.
Signature Mapping TBDx further eliminates the majority of human factor
limitations that currently hamper the accurate diagnosis of this disease, a
disease that globally infects 9 million people, with a mortality of almost
2 million per annum.
Today's most commonly used TB diagnostic test, sputum microscopy, is more
than 100 years old and detects only half of the world's new TB cases.
(**Source FIND) While new and more sophisticated genetic TB
diagnostics are available, their cost and sophistication restricts their
usage to mainly developed countries and complex individual cases.
Developing nations continue to rely on sputum microscopy and subsequent
culturing as the cornerstone diagnostic methods. (**Source WHO
guidelines) These developing nations, that bear more than 80% of total
global TB burden, lack the equipment, trained personnel, and monetary
resources to support the mass TB screening and diagnosis using the newer
tests now available. Current sputum analysis methods have historically
demonstrated low sensitivity and specificity, lengthy delays between sample
collection and diagnosis, and inconsistent quality due to human
limitations. The high throughput, huge volume of samples, and significant
variations in sputum staining quality further challenge the already
overburdened lab technicians and healthcare systems.
Since TB is the world's second leading cause of death, with persons with
active TB infecting on average an additional 10 to 12 people before
manifesting their illness, improving diagnostic methods is a critical
factor in reducing the spread of this infectious, but generally treatable
SM TBDx's greatest advantage for TB diagnosis is its ability to quickly
screen patient samples more consistently and efficiently than humans, to
deliver an accurate diagnosis, particularly on a negative sample or when
there are very few TB bacilli present. In these cases, technologists spend
hours viewing hundreds of fields of view (FOV) looking for the 'needle in a
haystack' on a negative sample. Worse, they may miss the one or two bacilli
in a sample and misdiagnose the patient as negative, only to have them
return months later with a more advanced stage of TB and having infected
others in the interim.
Signature Mapping TBDx can also be deployed as an effective decision
support tool to quickly review all FOVs and identify which FOVs to review
to confirm a diagnosis. By eliminating the need to review hundreds of FOVs
per patient, and millions per year, SM TBDx enables skilled technologists
to shift their efforts to more productive, higher value laboratory work.
Guardian Technologies, a provider of high-performance security and
healthcare solutions based on Intelligent Imaging Informatics (3i™), has
been working in a very close collaborative relationship with NHLS and The Aurum Institute for Health
Research, Guardian's clinical partner in South Africa, to develop
Signature Mapping TBDx to meet the NHLS's diagnostic and quality management
requirements. SM TBDx automates the diagnostic process, neutralizing the
human limitations associated with routine sputum microscopy and overcoming
extremes in slide quality and consistency. The Signature Mapping
laboratory/pathology platform, the core engine for TBDx, can be developed
and applied to many laboratory-diagnosed diseases such as malaria, leprosy
Dr. Gerrit Coetzee, Head of the South African National TB Reference
Laboratory, said, "The NHLS has welcomed this collaboration to develop an
advanced TB detection and diagnostic technology to automate the detection
process, with the promise of increased productivity and economic gains
through the more rational deployment of scarce technologist staff. With TB
patient volumes growing annually, automation will enable us to produce
results more efficiently while providing diagnoses that are more accurate
and consistent to stem the spread of TB. We have been impressed with the
strides Guardian Technologies has made in developing the Signature Mapping
detection system. We are looking forward to having them return for Phase
II testing of throughput and clinical performance after integrating their
detection technology with a fully integrated automated microscope and slide
processing and management system, which NHLS would be keen to deploy. A
successful integration of an automated technology could translate to saving
thousands of lives and improving quality of life for South Africans."
Bill Donovan, Guardian Technologies' President, stated, "Signature Mapping
TBDx delivered the superior results that we anticipated, and we are very
pleased that the NHLS has requested that we integrate it with a customized
high-throughput automated slide handling system. We believe that the SM
TBDx-integrated system will be unrivaled in its ability to accurately
diagnose TB at an affordable cost to the developing world."
Dr. David Clark, The Aurum Institute's Deputy CEO, said, "Much exciting
progress has been made in taking this technology from concept to reality.
We are looking forward to completing the project, rolling the technology
out in high burden TB countries, and then developing new solutions for
other diseases that plague the globe."
** TB Information:
World Health Organization
Foundation for Innovative New Diagnostics
About The Aurum Institute for Health Research
The Aurum Institute is an independent medical scientific organization for
the treatment of and research into epidemic and other diseases in
developing countries. 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
About Guardian Technologies International, Inc.
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.
Airport Security: Guardian's technology complements and enhances
current-generation baggage x-ray scanners with the ability to automatically
and effectively detect, locate, and identify explosives and other types of
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.