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The Digital LightCycler® System is a semi-automated system for detection and absolute quantification of nucleic acid target copy number, intended for in vitro diagnostic use by professional users in diagnostic and screening laboratories.

The system is comprised 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.", "Country": "XG", "Code": "Intended Use", "Name": "Intended Use" }, { "Language": "en", "Value": "The system is a nucleic acid quantification system that uses digital PCR technology (dPCR). 

The system partitions a sample into a large number of nanowells to allow for absolute quantification of a target nucleic acid sequence without a standard curve.

The system allows for a wide range of applications, e.g., in oncology by analyzing cell-free DNA, rare mutations, copy number variations, and gene expression, or in infectious disease diagnostics by detection and quantification of low viral loads.

The main features of the system are:
  • Digital PCR technology (dPCR) for detection of low target concentrations
  • 6 fluorescence channels for multichannel detection
  • 3 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 to emulate the partitioning of a larger sample volume into an even higher number of nanowells
  • 3 types of nanowell plates (universal, high resolution, high sensitivity) for different applications
  • Partitioning of up to 8 samples on 1 nanowell plate in the partitioning engine
  • Processing of up to 96 samples on 12 nanowell plates on the analyzer
", "Country": "XG", "Code": "Product Description", "Name": "Product Description" } ] } } ] }

Digital LightCycler® System

Unleash the true power of digital PCR

digital lightcycler product thumbnail
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The 4 pillars of advancement*
Sensitivity

 

The Digital LightCycler® System has an enhanced ability to detect minimal DNA or RNA molecules:

  • High-sensitivity 20,000 partition plate w/ 45μl reaction volume
  • 5x concentrated master mixes (RNA, DNA) enable high sample utilization, which means more confidence in results
  • Little rain and clear cluster separation means setting thresholds is easy
Precision

 

The Digital LightCycler® System’s high resolution 100,000 plate offers laboratories:

  • The ability to more likely discriminate small differences between samples
  • Superior cluster tightness and clarity of results
  • Absolute quantification of results
Flexibility

 

The Digital LightCycler® System brings all these advancements together on one system, offering a bold step forward in digital PCR:

  • Choose batch size increments of between 8 and 96 samples per run
  • Combine lanes for results of a single sample to increase resolution
  • Simplify workflow with sample tracking and automated data analysis
  • Enable high multiplexing with a 6 optical channel analyzer (Demonstrated with both DNA and RNA reagents)
  • Address multiple challenges at once with three plates for different application needs (Universal, High Sensitivity, High Resolution)

Quick, clear, reproducible results give great confidence with the potential for shorter turnaround for publishable scientific research and the potential development of clinically viable assays.

Integration

 

Bringing it all together, the Digital LightCycler® System brings reliable confidence in results:

  • Chemistry of generic reagents:
    • 5x concentrated master mixes means greater potential sample volume input
    • DNA and RNA optimized for multiplexing
    • Filling dye control that validates partitioning
  • 6 optical channels
  • Nanowell plate types: Solid phase partitioning instead of droplets increases reliability and replicability
  • Closed system minimizes the chance of amplicon contamination
  • Laboratory Information Digital LightCycler® System connectivity means simple digital workflow and sample tracking
  • Algorithm for sophisticated rejection of non-PCR artifacts
  • Absolute quantification without the need for standard curves
Bespoke testing with 3 one-of-a-kind1-4 nanowell plates

The unique hexagonal-shaped nanowell partitions and the filling dye that validates partitioning gives the Digital LightCycler® System the ability to handle a wide variety of extracted samples such as FFPET, cfDNA, Whole Blood, and more.

Through these partitions, target sequences are efficiently concentrated within isolated microreactors. This concentration effect reduces template competition, thereby enabling the detection of rare mutations and allowing for a higher tolerance to inhibitors present in a sample.

thumbnail-digital-lightcycler-hexagon-3
High Resolution

 

15μL, 100,000 partitions

Copy Number Variation

NIPT

Human Genetic Disease

thumbnail-digital-lightcycler-hexagon-2
Universal Plate

 

30μL, 28,000 partitions

Gene Expression

Transplant Rejection

thumbnail-digital-lightcycler-hexagon-1
High Sensitivity

 

45μL, 20,000 partitions

Cell-free DNA

Oncology

Rare Mutation Detection

digital lightcycler thumbnail image 1
Increased flexibility with 6-channel multiplexing*

6 advanced optical channels enable a high degree of multiplexing for DNA or RNA targets.

 

  • Batch size increments of between 8 and 96 samples per run
  • Demonstrated with both DNA and RNA reagents
  • Analyzer run times vary for different batch sizes to save time on smaller batches
High sample utilization with with 5x concentrated concentrated DNA and RNA master mixes*

Get the most out of your samples with the Digital LightCycler® System's 5x concentrated master mixes.

 

  • Improved sample percentage in each reaction means confidence in results
  • 1 Step RNA (RT) with a hold time of just 15 minutes
  • DNA and RNA optimized for multiplexing
  • Filling dye control that validates partitioning
  • Single tube
  • 50-75% less primer/probe usage
digital lightcycler sample utilization vs competitive system

Simple workflow and data tracking

thumbnail small icon digital lifecycler 1

1. First batches are created either manually or with orders from the Laboratory Information System (LIS). The system automatically sets up the layout and creates the samples.

thumbnail small icon digital lifecycler 2

2. The newly extracted samples are then samples are then transferred to the PCR where a pipette is used to mix the samples and the master mix and the nanowell plate of choice is scanned into the web application for full sample tracking.

thumbnail small icon digital lifecycler 3

3. The PCR mix is then transferred into the nanowell plate which is then loaded into the partitioning engine. This is done for each plate.

thumbnail small icon digital lifecycler 4

4. All the plates are then loaded into the Analyzer.

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5. After the run is complete, positives and negatives are counted up and the Poisson calculation is applied.

thumbnail small icon digital lifecycler 6

6. Results are validated and then sent back to the LIS.

product image digital lightcycler
Focus on core tasks with comprehensive customer support

The Digital LightCycler® Service Software will help automate workflow and manage data ensuring no external calculations, software and processors will be required to collate, analyze, and contextualize assay results.

 

  • Remote accessible software
  • Automatic clustering
  • Flexible for development of assays
  • Build your own In-Vitro Diagnostics
  • Analysis types
    • Absolute Quantification
    • Indel
    • Copy Number Variation
  • Full sample tracking
  • Laboratory Information System interface
thumbnail digital lightcycler small image screen
Designed to make workflows simple and easy

Find out how the latest digital PCR systems are impacting modern research laboratories and opening up new avenues for discovery.

 

Download the workflow brochure

A comprehensive suite of powerful features

View Full Table

A comprehensive suite of powerful features

Backed up by a strong history of IVD leadership and recognition with the original LightCycler® System, the Digital LightCycler® has a combination of unique features that make it a powerful competitor in the digital PCR space.1-4

 

Competitor A

Competitor B

Competitor C

Competitor D

Roche

Partitions

20,000 - 100,000 8,500 - 26,000 20,000 - 30,000 20,000 20,000 - 28,000 - 100,000

Samples

1 - 96 24, 96 4,12 1-16 8-96

Concentration on MMx

2x, 4x  4x 5x, 10x 2x 5x

Channels

4, 6 2, 5 6 4 6

Total volume

20μL 12μL, 40μL 7μL, 25μL 20μL 15μL - 45μL

MD Label

Yes No No No Yes

Unambiguous thresholding = Confident results

 

Backed up by a strong history of IVD leadership and recognition with the original LightCycler® System, the Digital LightCycler® has a combination of unique features that make it a powerful competitor in the digital PCR space1-4.

  • Clear cluster separation of positives and negatives
  • Very little rain

 

digital lightcycler chart 1

Roche Digital LightCycler® System

digital lightcycler chart 2

Competitor A

digital lightcycler chart 3

Competitor B

A wide range of research possibilities

View Full Table

A wide range of research possibilities

The Digital LightCycler® System’s unique precision and sensitivity capabilities make it ideally suited for a number of real-world applications and research areas:

Application Oncology

Rare species and

variant detection

Microsatellite

instability detection

Pathogen load

Digital

LightCycler® 

System Potential

Known specific variants of interest and tracking of treatment efficacy and disease progression  Absolute quantification without a standard curve Hyper sensitivity Absolute quantification with a standard curve
Application Graft rejection monitoring in transplant cases

ID - Environmental

surveillance

Pharma - Large

clinical trials

Noninvasive

prenatal testing

Digital

LightCycler® 

System Potential

Ability to measure graft cfDNA (est. Molecular Market 600 mio CHF)

High sensitivity and precision.

Inhibitors for particular sample

types may mask NA content

making difficult the rtPCR

curve analysis

Large volume testing for specific

biomarkers & larger accuracy

than rtPCR

Limited accuracy with antigen

testing

Registration status

IVD

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Making the leap from idea to impact

Modern clinical research demands a leap forward in instrumentation capability. With its flexibility, quality and advances in sensitivity and precision, the Digital LightCycler® System can help laboratories push the boundaries of clinical research forward

 

Unleash the true power of digital PCR with the Roche Digital LightCycler® System.

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Explore the oligo houses of our Partner MilliporeSigma

Discover their portfolio

 

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* Roche data on file: DH_02365.01_031B_Digital_LightCycler_Reagent_Feasibility_Report_v3, Document Number: 0000000000001200000501942

Roche data on file: DH-02365.01-500E_Digital LightCycler System Performance report

Roche data on file: DHF Digital_LightCycler_Reagent_Feasibility_Report

Roche data on file: DH-02365.01-008B_Digital_LightCycler_System_Feasibility_Report

  1. https://www.qiagen.com/us/products/instruments-and-automation/pcr-instruments/qiacuity-digital-pcr-system/ (last accessed on 08/20/2022)
  2. https://www.bio-rad.com/en-us/life-science/digital-pcr/qx-one-droplet-digital-pcr-ddpcr-system (last accessed on 08/20/2022)
  3. https://www.stillatechnologies.com/6-color-dpcr/ (last accessed on 08/20/2022)
  4. https://www.thermofisher.com/order/catalog/product/4489084 (last accessed on 08/20/2022)

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