Highly Successful Clinical Trial Results Advance Signature Mapping TBDx Solution to Operational Evaluation in South Africa
December 22 2010 - 2:20PM
Marketwired
Signature Mapping Medical Sciences, the wholly owned medical
diagnostic imaging subsidiary of Applied Visual Sciences (OTCBB:
APVS), announces highly successful intermediary clinical trial
results. Signature Mapping TBDx (TBDx) demonstrated an extremely
high sensitivity, the ability to locate and identify more TB
bacilli, a major shortcoming in worldwide TB diagnostics.
Dr. Gerrit Coetzee, Head of the National TB Reference
Laboratory, stated, "If TBDx clinical trial results, on the
remaining studies, continue to demonstrate this measured detection
performance it will certainly have a major impact on the detection
of TB in South Africa. The automated system and supporting data are
very impressive. TBDx will vastly improve diagnostic performance,
resulting in faster medical attention for the patient. This speaks
directly to saving more lives and reducing the growth rate of
TB."
The independently prepared and analyzed clinical data was
presented to a panel of South African TB experts, including the top
executives at the South African National Health Laboratory Services
(NHLS). "The study used slides from a well characterized group of
patients detected through symptoms and chest radiographic
screening. The performance characteristics suggest that the TBDx
technology may have an important public health benefit by detecting
more TB cases sooner, thereby interrupting TB transmission," stated
Dr. Dave Clark of the Aurum Institute.
In addition to demonstrating the fully automated 200-slide TBDx
system, Signature Mapping Medical Sciences presented the full
analytical details of the intermediary clinical trial to a panel of
leading experts in the field of TB detection.
The panel included:
- Sagie Pillay -- CEO of NHLS
- Dr. Wendy Stevens -- NHLS Director of Clinical Programs,
Infectious Diseases
- Dr. Gerritt Coetzee -- Head of the National TB Reference
Laboratory
- Dr. Bernard Fourie -- Director of the Medical Research Council
of South Africa, Chief Scientific Officer of Medicine in Need, and
Extraordinary Professor in the Dept. of Medical Microbiology at the
School of Health Sciences - University of Pretoria
- Dr. Hendrik Koornhof, Emeritus Professor of Microbiology --
University of the Witwatersrand and Advisor to NHLS on infectious
diseases
- Dr. Gavin Churchyard -- CEO of the Aurum Institute
- Dr. David Clark -- Deputy CEO of the Aurum Institute
The following preliminary statistical data represents
intermediate clinical trial results:
- TBDx is exceptionally sensitive, with high predictive values on
non-scanty positive and normal cases;
- TBDx was 74% more sensitive than the highly experienced
microscopist;
- Microscopist sensitivity improved by 25% when presented with
fields of view from potential scanty cases. By comparison, the
World Health Organization recommended the use of LED microscopes
based upon approximately a 10% increase in microscopist
sensitivity;
- TBDx had low specificity on potential scanty cases (between 1
and 4 potential TB bacilli);
- Specificity improved markedly when the positive fields of view,
on those potential scanty cases, were reviewed by a
microscopist.
Given TBDx's operational flexibility, NHLS will determine the
various workflow configurations and the number of digital images to
be collected under various clinical detection scenarios prior to
operational deployment. In support of NHLS procurement
requirements, TBDx will be installed at one additional laboratory
to move the technology through the required "demonstration project"
stage.
With the South African government's plans to screen
approximately 15 million citizens for HIV and TB it is critical to
find a low-cost, high-performing, and fast method for screening and
diagnosing TB, with high sensitivity. Without an improved
methodology the laboratory system will be stressed beyond its
current capacity, and the potential for misdiagnosing TB cases
amongst co-infected patients will be high. Post-completion of the
clinical trial and the demonstration project, Dr. Coetzee has
projected that NHLS will issue an order for approximately six
200-slide TBDx systems and 40-50 scaled down 8-slide automated
systems. These systems will be deployed in a regional environment
and used to determine the full extent of NHLS's system-wide
requirements.
The panel agreed that sputum microscopy will not be replaced in
the near future by any other detection technology, principally due
to cost and speed issues. The much publicized DNA analysis system
is currently undergoing clinical trials and evaluation at NHLS, and
it is the belief of the panel that TBDx is every bit as sensitive
as the DNA system, but without the specificity problems associated
with the DNA system.
Dr. Churchyard stated, "I'm excited to say that the TBDx
preliminary clinical results are promising and of critical
importance to the worldwide fight to detect and control TB. The
data suggest that the combined utilization of the laboratory
microscopist and TBDx is a more sensitive approach to quickly
identify TB, especially in difficult to analyze cases. TBDx holds
the promise of providing the world with a cost effective screening
tool capable of identifying greater numbers of TB positive cases.
The remaining clinical trial must be completed quickly, and the
results published so that the scientific community can understand
the technology's contribution towards the search for a low-cost TB
screening device. I would expect that the completion of the
clinical trial will definitely demonstrate that TBDx should be
moved into laboratory operation as expeditiously as is
feasible."
About TBDx The SM TBDx solution combines
Applied Visual Sciences 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:
http://www.youtube.com/watch?v=Wn6k5YxhFjU
About National TB Research Laboratory The
NHLS forms a national network of integrated pathology laboratories
throughout the country that utilize common laboratory management
systems and transport networks to facilitate transport of
specimens, referral of tests to reference laboratories and delivery
of results. Approximately 265 laboratories are included in the
NHLS, employing about 6,500 people. Their activities comprise
diagnostic laboratory services, research, teaching and training,
and production of sera for anti-snake venom, reagents and media.
All laboratories provide laboratory diagnostic services to the
national Department of Health, provincial hospitals, local
authorities and medical practitioners.
About Aurum Institute Aurum Institute, a
leading international research institute in South Africa committed
to the detection and treatment of HIV, malaria and tuberculosis.
Aurum has received many international awards for their work in HIV,
TB and malaria. Aurum's research has been funded by the Gates
Foundation, The World Health Organization, CREATE, various South
African mining companies and the South African Government.
About Applied Visual Sciences, Inc.
Applied Visual Sciences, Inc. is the holding company and IT
development organization for subsidiaries specializing in
high-performance imaging analysis technologies and advanced
analytics for automated recognition of targets of interest. Applied
Visual Sciences' subsidiaries include Guardian Technologies
International, Inc., a homeland security/defense technology entity,
and Signature Mapping Medical Sciences, Inc., a healthcare
technology entity. The company is quoted on the OTC Bulletin Board
under the symbol APVS.
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uncertainties, including the risks associated with the effect of
changing economic conditions, capital raising activities, trends in
the markets, variations in the company's cash flow, competition,
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.
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