Medical practitioners in Europe can use Bio-Rad’s CE-IVD marked QX200 Droplet Digital™ PCR (ddPCR™) System, IVD for highly-accurate diagnostic detection and quantification of nucleic acids, aiding clinical decision-making in the treatment of diseases ranging from cancer to transplant rejection and viral infection.
The system includes a QX200™ Droplet Generator, QX200™ Droplet Reader, and QuantaSoft™ software. The droplet generator and reader are CE-IVD marked for use in the European Union for in vitro diagnostics and are the only digital PCR instruments available for use in a clinical laboratory.
The product is used to partition a ddPCR reaction mixture into thousands of nanoliter-sized droplets. After endpoint PCR on a thermal cycler, droplets are read individually as they are streamed single file past a two-color optical detection system on the QX200 Droplet Reader. The PCR-positive and PCR-negative droplets are counted to provide absolute quantification of target DNA.
The product features:
• Most precise and sensitive digital PCR solution for a wide variety of diagnostic applications
• Flexible digital PCR chemistry, optimized for TaqMan probe and EvaGreen applications
• Convenient assay design – no standard curves
• Flexible assay setup – scalable for high sensitivity or high throughput
• Easy-to-use workflow with 96-sample throughput
Applications:
• Liquid biopsy cancer detection and monitoring
• Gene editing validation
• Viral load and residual disease monitoring
• Copy number determination
• Gene expression analysis

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