The CPC001 test is currently based upon the Luminex xMAP multi-plexed assay platform. Luminex develops, manufactures, and markets the xMAP technology with applications throughout the life-sciences industry and clinical diagnostics. Open-architecture xMAP technology enables multiplexing of biological tests (bioassays) reducing time, labor, and costs over traditional methods. Systems using xMAP technology perform discrete bioassays on the surface of color coded beads known as microspheres which are then read in a compact analyzer. Using multiple lasers and high-speed digital-signal processors, the analyzer reads multiplex assay results by reporting multiple colors on each individual microsphere particle.
xMAP technology works by using proprietary techniques to internally color-code microspheres with two fluorescent dyes. Through precise concentrations of these dyes, up to 500 distinctly colored bead sets can be created, with each bead set coated with a reagent specific to a particular bioassay. Reagents may include: antigens, antibodies, oligonucleotides, enzyme substrates, or receptors. After an analyte from a test sample is captured by the bead, a reporter molecule, labeled with a different fluorescent dye, is introduced to complete the reaction on the surface of each microsphere. Next, the microspheres pass rapidly through a laser, which excites the internal dyes marking the microsphere set. A second laser excites the fluorescent dye on the reporter molecule. Finally, high-speed digital-signal processors identify each individual microsphere and quantify the result of its bioassay based on fluorescent reporter signals.
» Here is a short video that demonstrates the xMAP technology.
The CPC001 test was developed using Luminex polystyrene bead technology. This technology is appropriate for LDTs, but does not fit in with CPC's long term plan of developing an IVD kit approved by the FDA. CPC is currently migrating from the Luminex bead technology to protein microarray technology. Protein microarrays are poised to become a central proteomics technology, important in basic research and commercially for biotechnology enterprises. CPC is taking advantage of this development.
Migrating to a microarray technology offers several advantages over bead based technology such as:
• No restrictions to the field of use
• No royalties or commercialization agreements needed
• Lower cost of instrumentation
• Reduced costs of key reagents
• Automation-friendly, i.e. no filter plates
• Increased sensitivity
• Faster throughput
Protein microarrays are rapidly becoming established as a powerful means to detect proteins, monitor their expression levels, and investigate protein interactions and functions. The industry is seeing explosive progress and interest at the moment and has become one of the most active areas emerging in biotechnology today. The objective behind protein array development is to achieve efficient and sensitive high throughput protein analysis, carrying out large numbers of determinations in parallel by automated means. While they were conceived originally as miniaturized immunoassays, further development is being driven by genome projects on the one hand and improved expertise in expression of recombinant proteins on the other. Protein arrays make possible the parallel multiplex screening of thousands of interactions, encompassing protein-antibody, protein-protein, protein-ligand or protein-drug, enzyme-substrate screening, and multi-analyte diagnostic assays. In the microarray or chip format, such determinations can be carried out with minimum use of materials while generating large amounts of data.
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