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Organization Contact Information

Name: Signature Mapping Medical Sciences
Street 1: 525K East Market Street
Street 2: 116
City: Leesburg
Province: Virginia
Post Code: 20176
Country: United States of America
Phone: (703) 539-6190
Email: info@signaturemapping.com
Web Site: http://www.signaturemapping.com

Focal Point Contact Information

Salutation: Mr
First Name: William (Bill)
Last Name: Donovan
Title: Chief Executive Officer
Email: bill.donovan@signaturemapping.com
Phone: (703) 539-6190

Alternate Focal Point Contact Information

Salutation: Mr
First Name: Sean
Last Name: Kennedy
Title: President
Email: sean.kennedy@appliedvs.com
Phone: (703) 539-6190

General Information

Board Constituency: Private sector
Organization Type - Primary: Private Sector
Organization Type - Secondary: Company
Is your organization legally registered in your country: Yes
Organization Reach: International
Organization Description:
Signature Mapping Medical Sciences, Inc. (SMMS) is a wholly-owned subsidiary of Applied Visual Sciences, Inc., focused on the development of automated medical diagnostic and decision support software solutions for radiology and laboratory/pathology applications.

Signature Mapping Medical Sciences, Inc. (SMMS) has started 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. 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 microsco
 
Total number of staff in your organization: 26 - 50
Number of full-time staff who are directly involved with TB: 11 - 25
Number of part-time staff who are directly involved with TB: 1 - 5
Number of volunteers who are directly involved with TB: 0
 
What is your organization's annual budget (USD) dedicated to TB? $1,001-$5,000
How did you hear about the Stop TB Partnership: Involvement in TB control provision
If you were informed or referred by another partner of the Stop TB Partnership please tell us who:
Why do you wish join the Stop TB Partnership: Network with other partners
 
Are you a member of a Stop TB national partnership: No
Are you in contact with your national TB programme: No
Please tell us how your organization is contributing to your country's national TB control plan:
N/A
 

Geographical Reach

Which country is your headquarters located in: United States of America
Which WHO region is the main focus of your work: African
Which countries do you do operate in:
(This includes countries you are conducting activities in)
India
South Africa

Specializations

Provision of drugs, diagnostics and commodities
Research and Development

Specializations in Countries

Provision of drugs, diagnostics and commodities India
Provision of drugs, diagnostics and commodities South Africa

Contribution

Please tell us how your organization will contribute to the Global Plan to Stop TB by briefly describing its involvement in any of the areas of work listed below:

New Diagnostics:
Signature Mapping Medical Sciences has developed a fully automated slide management system that eliminates the need for a human to look at slides through a microscope for the detection of TB in auramine-O stained slides. It is currently undergoing clinical evaluations in South Africa. A single system can handle up to 200 slides and provide a highly sensitive diagnosis of tuberculosis. The product name is TBDx which accurately provides a TB diagnosis within minutes, at a very low cost and with minimal human intervention – making it an ideal mass screening tool for the masses in countries with high burdens of TB. The company also has developed a solution (TBDxV) for Ziehl-Neelsen stained sputum slides for display and technician diagnosis.

Declaration

Declaration of interests:
I don't believe there to be a conflict of interest at this time.

Application date: March 3, 2011
Last updated: June 16, 2014