Cepheid develops integrated sample preparation and detection systems for rapid molecular diagnostic applications at a point of use environment. Currently, Cepheid has the GeneXpert system, which is a cartridge and instrument platform for integrated sample preparation and real-time PCR detection of target nucleic acids in biological samples. The current configuration of the GeneXpert system filters bacteria from samples and then lyses the bacteria for PCR detection of endogenous DNA. The next level in the evolution of the GeneXpert platform is to incorporate a nucleic acid purification function to address biological samples such as frozen tissue sections, where the presence of inhibitors may stop PCR. We believe that this automated system with nucleic acid purification will be invaluable in clinical diagnostic laboratories and will find many uses in molecular oncology applications. Specifically, our hypothesis is that a disposable fluidic cartridge, with integrated functions of RNA isolation and real-time QRT-PCR, can accomplish sample preparation and analysis of tissue cross-sections for detection of cancer marker expression in 25 minutes or less.
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