Signature Mapping Medical Sciences to Start Phase II Clinical Trial for TBDx Fully Automated Tuberculosis Detection System
20 Ottobre 2010 - 2:45PM
Marketwired
Signature Mapping Medical Sciences, Inc. (SMMS) will start the
Phase II clinical trial of Signature Mapping TBDx (TBDx) on October
21, 2010. The Aurum Institute for Health Research, The London
School of Hygiene and Tropical Medicine, The South African National
Health Laboratory Services, Medicine in Need, and George Washington
University are collaborating on this clinical trial with SMMS, the
healthcare diagnostic technology subsidiary of Applied Visual
Sciences, Inc. (OTCBB: APVS). TBDx is a fully automated,
hardware-software integrated laboratory diagnostic system for the
detection of tuberculosis in stained sputum slides.
The primary objective of the trial is to evaluate the
performance of the TBDx system in identifying tuberculosis on
microscopy slides against the performance of routine microscopists,
using culture as the "gold standard." The trial is designed as a
mono-centric, blind study to be conducted in the offices of SMMS
under the proctorship of Dr. Krishna K. Banaudha, George Washington
University, Department of Biochemistry and Molecular Biology.
The clinical specimens to be evaluated in the trial have been
extracted from a larger set of 3,300 specimens of tuberculosis
suspect patients evaluated at South African mine routine health
services as part of the Thibela TB cluster-randomized trial study
in South Africa. To maintain the highest ethical standards, the
data from this program was collected, verified, and entered into a
database under the control of a statistician in South Africa and
will not be made available to SMMS. Participants in the study are
identified by a unique study number and no information about the
participants will be provided to SMMS.
The trial will capture and report on the sensitivity,
specificity, positive predictive value and negative predictive
value of the TBDx system compared to routine microscopists'
readings, and ultimately evaluated against cultured results. This
Protocol complies with SMMS's ISO standard (ISO-9000 2001). The
study will be documented for publication in a peer-reviewed medical
journal and for presentation at an appropriate conference. The
National Health Laboratory Services in South Africa have partnered
in this study. The Thibela TB Study belongs to the Consortium to
Respond Effectively to the AIDS and TB Epidemic (CREATE) comprised
of high-level policy makers from both the Stop-TB Program of the
World Health Organization and UNAIDS. This will enable the results
of this study to quickly reach and influence high-level policy
makers both nationally and internationally.
About Signature Mapping Medical Sciences,
Inc.: Signature Mapping Medical Sciences, a wholly owned
subsidiary of Applied Visual Sciences, Inc. (OTCBB: APVS), produces
image analysis software to automate and improve the detection of
diseases and other health conditions, including tuberculosis,
breast cancer and brain trauma.
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 are 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.
Safe Harbor statement under the Private
Securities Litigation Reform Act of 1995 Statements in this
news release looking forward in time involve risks and
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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CONTACT: For Applied Visual Sciences: Michael Trudnak +1
703-464-5495 For Signature Mapping Medical Sciences: Richard
Borrelli +1 703-464-5495 Media: Julie Shepherd Accentuate PR +1
815-479-1833 Email Contact
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