HERNDON, VA--(Marketwire - October 20, 2010) - 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
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.
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