Product Description

Mutation Detection – Oncology

Key Features:

• Semi-Automated Workflow: The Digital LightCycler® System supports a semi-automated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT).
• Digital Endpoint PCR Analysis: The system performs digital endpoint PCR analysis of microfluidic partitions, combining the functionalities of instrumentation, consumables, reagents, and data management for efficient workflow from sample partitioning to result interpretation.
• Intended Use: Designed for in vitro diagnostic use by professional users in diagnostic and screening laboratories.
• System Components: The system consists of the Digital LightCycler® Analyzer, the Digital LightCycler® Partitioning Engine, and specified consumables, core reagents, and application software. All assays are developed independently of the Digital LightCycler® System.
• Digital PCR Technology (dPCR): The system uses dPCR technology for absolute quantification of nucleic acid target copy number without a standard curve.
• Advanced Applications: The system allows for a wide range of applications, such as oncology by analyzing cell-free DNA, rare mutations, copy number variations, and gene expression, or infectious disease diagnostics by detecting and quantifying low viral loads.
• Main Features:
  • Digital PCR technology for low target detection.
  • Six fluorescence channels for multichannel detection.
  • Three analysis types (absolute quantification, CNV, indel).
  • Workflows for diagnostic and development purposes.
  • Development software for detailed data analysis.
  • 5x concentrated DNA and RNA master reagents for higher sample fraction.
  • Partitioning of each sample into a large number of nanowells on a dedicated nanowell plate.
  • Merged lanes emulate the partitioning of a larger sample volume into an even higher number of nanowells.
  • Three types of nanowell plates (universal, high resolution, high sensitivity) for different applications.
  • Partitioning of up to eight samples on one nanowell plate in the partitioning engine.
  • Processing of up to 96 samples on 12 nanowell plates on the analyzer.