General Information |
| 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 |
| 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
|
