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Secure Web-Based Flow Cytometry in Clinical Use and Translational Research

Award Information
Agency: Department of Health and Human Services
Branch: National Institutes of Health
Contract: 1R43AI094929-01A1
Agency Tracking Number: R43AI094929
Amount: $268,481.00
Phase: Phase I
Program: SBIR
Solicitation Topic Code: NIAID
Solicitation Number: PA10-122
Solicitation Year: 2012
Award Year: 2012
Award Start Date (Proposal Award Date): N/A
Award End Date (Contract End Date): N/A
Small Business Information
United States
DUNS: 828762513
HUBZone Owned: No
Woman Owned: No
Socially and Economically Disadvantaged: No
Principal Investigator
 (650) 265-7806
Business Contact
Phone: (650) 265-7806
Research Institution

DESCRIPTION (provided by applicant): The ability of flow cytometry to measure 30 or more parameters on individual cells makes it a perfect tool for analyzing complex mixtures of cells such as peripheral blood or tumor sample from patients with various diseases. New assays have enabled researchers to measure signaling pathways inside individual cells, providing insight into the pathology of cancers and immunological disorders. Cytobank is a web--and#8208;based software platform for the management, sharing, and analysis of flow cytometry data, providing end users with the ability to generate complex data visualizations such as heatmaps directly from raw flow cytometry data. Currently, multiple software platforms are required for fully analyzing and disseminating data from flow cytometers, therefore making it difficult to comply with the strict requirements of patient information protection regulations. In this grant, we will extend the capabilities of Cytobank by ensuring compliance with 21 CFR Part 11 and developing templates for commonly performed clinical assays. This will allow clinical researchers to move cutting edge flow cytometry assays into the clinic, as they will be able to securely share data with approved individuals who can assist in data analysisand statistical interpretation. The Aims of the grant are to 1) implement an electronic signature for records in Cytobank, 2) create an audit trail for all steps of data management and analysis, and 3) create analysis templates for routine analyses in clinical immune monitoring and translational research in cancer. The ultimate goal of making Cytobank clinically compliant is to enhance global health by enabling more efficient translation of research findings into clinical settings, primarily by connecting clinicians and researchers via a simple to use interface for data management and analysis. PUBLIC HEALTH RELEVANCE: Flow cytometry is used in clinical research and for diagnosis and monitoring of patients with diseases ranging from cancer to autoimmunity. In this grant, we propose to enhance a previously built web-based software analysis suite, called Cytobank, to make all aspects of data management and analysis clinically compliant under 21 CFR Part 11. This will enable important new tools developedin the research laboratory to be translated into clinical settings and enhance patient treatment with cutting edge flow cytometry assays.

* Information listed above is at the time of submission. *

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