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--‐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 analysis and 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 developed in the research laboratory to be translated into clinical settings and enhance patient treatment with cutting edge flow cytometry assays.

Agency
National Institute of Health (NIH)
Institute
National Institute of Allergy and Infectious Diseases (NIAID)
Type
Small Business Innovation Research Grants (SBIR) - Phase I (R43)
Project #
1R43AI094929-01A1
Application #
8253426
Study Section
Special Emphasis Panel (ZRG1-IMST-J (15))
Program Officer
Beisel, Christopher E
Project Start
2012-03-01
Project End
2014-02-28
Budget Start
2012-03-01
Budget End
2014-02-28
Support Year
1
Fiscal Year
2012
Total Cost
$268,481
Indirect Cost
Name
Cytobank, Inc.
Department
Type
DUNS #
828762513
City
Mountain View
State
CA
Country
United States
Zip Code
94043