Decision Biomarkers, Inc. (DBI) has developed a novel, automated, immunoassay platform to simultaneously evaluate multiple biomarkers in a single reaction vessel. Biomarker panels are used for many research and clinical indications.

We have generated data from a multiplex assay measuring a panel of 10 angiogenesis factors: VEGF, VEGF-R2, ICAM-1, TIE-2, PLGF, TIMP-1, HGF, FGF basic, E-selectin, and IL-8. The heart of the system is a microarray of the biomarker specific monoclonal antibodies spotted onto a glass slide which has been coated with an ultra-thin, two-dimensional film of nitrocellulose.

This microarray is assembled in a plastic biochip (MAX BIOCHIP®): a self-contained device with a series of microfluidic channels, valves, sensors, and reagent chambers containing dried, biotinylated detection antibodies, streptavidin-conjugated Dy-Light, and wash buffer. The biochip is processed in the AVANTRA® Biomarker Workstation following injection of 200 ml of sample (100 ul of plasma diluted in 100 ul of buffer). The instrument initiates, in sequence, the flow of sample, detection antibody, label, and buffer, across the array. The end result is in a fluorescent labeled complex that is then imaged by an internal CCD camera. Spot intensity is correlated with analyte concentration by instrument software.
Master curves electronically stored in the instrument are used to calculate analyte concentrations. Each angiogenesis factor assay has a 2-4-log dynamic range and analytical sensitivities competitive with individual ELISA's. Of note, normal ranges for these analytes range from the low pg/ml for IL-8 to high ng/ml for ICAM-1. DBI has developed a proprietary method enabling all analytes to be evaluated in a single reaction despite this 5 log spread in analyte concentration. Both the intra- and inter-assay precision results yielded mean CV's consistently less than 15%.

Reproducibility was demonstrated by overlapping curves following replicate standard evaluation. The unique surface chemistry, marker specific reagents, and enhanced biochip microfluidics and instrument automation, all combine to produce a robust and easy to use multiplex immunoassay. Currently in develop-ment are a 12-plex cardiac panel and a toxicity panel, which will both soon be available. Additionally, assays for numerous other biomarker panels are slated for future development. Custom assay development is also available.

In summary, DBI has developed a sensitive and precise, multiplex immunoassay for 10 angiogenesis factors that runs on the new, automated platform, the AVANTRA® Biomarker Workstation.

Multiplex assay is illustrated below).

Angio Product Sheet

 View the Angio Poster here for a more in depth explanation

 "The Devices made by DBI and contained in this website are intended for research use only and not for diagnostic use such as reporting patient-specific results or for making medical decisions in clinical trials. These devices have not been reviewed by the FDA."