Biomarkers of Immunity Company™
Our automated laboratory diagnostic solutions provide dramatically faster and more sensitive ways to measure correlates of immune protection associated with bacterial vaccines.
FlowApps, in collaboration with the CDC, has patented a multiplexed, multivalent, high throughput process that is highly specific, easier, and up to 20 times faster than first generation reference methods for functional opsonophagocytic antibody detection.
FlowApps diagnostics enables pharmaceutical companies, bio defense firms, public health organizations and academic researchers to slash the time it takes to determine the efficacy of existing and candidate bacterial vaccines by measuring immunological end points as an alternative approach to assessing vaccine performance.
A Brief History of Opsonic Antibody Detection
The World Health Organization (WHO) and the Food and Drug Administration (FDA) have stressed the importance of Opsonic Antibodies as Serologic Correlates of Immunity. Presently, the accepted method for detection of Opsonic Antibodies is a first generation manual killing assay developed by Steiner et. al., at the United States Centers for Disease Control and Prevention (CDC). The original phagocytic assays developed by Steiner, et. al., established the utility of functional antibody measures. This method works well and has been established as the current "gold-standard". However, the first generation manual or "killing assay" uses viable (potentially infective) bacteria.
The "killing assay" other inherent advantages and drawbacks
* Sandra Romero-Steiner, Ph.D.(Classical Technology transfer opsonophagocytic killing type assay Power Point presented at the Pneumococcal Antibody Opsonization Assay Meeting, Supported by NIH/CDC/WHO, Sept., 2005)
||Volume of Sera
|Endpoint = Viability
The FlowApps Advantage
Flow Applications, Inc. and the United States Centers for Disease Control and Prevention (CDC) have developed automated technology for the detection of opsonic antibodies elicited by vaccination. This was accomplished by a cooperative research and development agreement (CRADA) between the Dr. George Carlone's lab at the CDC, Flow Applications Inc, and academic partners. The success of this CRADA resulted in FlowApps obtaining a patent (6,815,172 ) with the CDC as well as an exclusive license to commercialize multiplexed opsonophagocytic testing and assays. In 2008 FlowApps was also awarded the FLC Southeast Region 2008 "Excellence in Tech Transfer" award for our Multiplexed Opsonophagocytic Assay (OPA) technology.
Because manual phagocytic assays are time-consuming and technically cumbersome, FlowApps' multiplexing technologies connect serological measures to high-throughput automation.
In comparison to the first generation manual killing assay FlowApps' automated assay:
- Correlates with the manual assay
- Uses non-viable, non-infective targets
- Still uses culturable phagocytes
- Eliminates manual colony counting
- Is automated
- Eliminates discontinuous titers
- Is high throughput
- Uses far less sera and reagents
- Can meet FDA GMP guidelines
- Can be standardized
- Can eliminate inter-lab variability