See country-specific product labeling for regulatory status. System Digital LightCycler system Country Specific Labeling Digital LightCycler® System SYS_362 09 274 804 001 9 274 804 001 09274804001 9274804001 09274804001 Digital LC Analyzer Digital LC Analyzer 07613336175941 Instruments Not Available Not Available 09 224 777 001 9 224 777 001 09224777001 9224777001 09224777001 Digital LC Partitioning Engine Digital LC Partitioning Engine 07613336175934 Instruments Not Available Not Available The Digital LightCycler® System supports a semi-automated workflow to run Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT). The system performs digital endpoint PCR analysis of microfluidic partitions, combining the functionalities of instrumentation, consumables, reagents, and data management to provide an efficient workflow from sample partitioning to result interpretation.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. en 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 concentrations6 fluorescence channels for multichannel detection3 analysis types (absolute quantification, CNV, indel)Workflows for diagnostic and development purposesDevelopment software for detailed data analysis5x concentrated DNA and RNA master reagents for higher sample fractionPartitioning of each sample into a large number of nanowells on a dedicated nanowell plateMerged lanes to emulate the partitioning of a larger sample volume into an even higher number of nanowells3 types of nanowell plates (universal, high resolution, high sensitivity) for different applicationsPartitioning of up to 8 samples on 1 nanowell plate in the partitioning engineProcessing of up to 96 samples on 12 nanowell plates on the analyzer en

Digital LightCycler^® System

Country Specific Labeling

Image of a laboratory technician using the touchscreen on the Digital LightCycler® System

Unleash the true power of digital PCR

The Roche Digital LightCycler® system is the digital PCR instrument of tomorrow. With a unique combination of 3 nanowell plate configurations, 6 advanced optical channels, and 5x concentrated DNA and RNA master mixes, it has the potential to help your lab make the leap from publishing research to producing clinically viable assays.

High sensitivity and unambiguous thresholding^1-4

Backed by Roche’s legacy of IVD leadership with the original LightCycler® system, the Digital LightCycler® combines enhanced features and detection capabilities to deliver superior data visualization and high confidence in results—even with minimal target input.^1-4

What sets it apart:

High-sensitivity 20,000 partition plate with 45 μl reaction volume
5x concentrated master mixes (RNA, DNA) for high sample input and utilization
Clear cluster separation of positives and negatives with very little rain

Benefits at a glance

High resolution for increased precision^1-4

Digital PCR with 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

One consolidated, flexible digital PCR system^1-4

The Digital LightCycler® system is designed to provide flexibility and efficiency, offering features that streamline workflows and adapt to a variety of laboratory needs:

Choose batch size increments of between 8 and 96 samples per run
Combine lanes for the 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, and High Resolution)
Analyzer run times vary for different batch sizes to save time on smaller batches
Support assay development with a flexible platform suited for evolving research needs
Option to design lab-developed tests (LDTs) with in-house assay customization capabilities

Seamless integration^1-4

Bringing it all together, the Digital LightCycler® System integrates advanced reagents, smart digital connectivity, and robust hardware design to deliver reliable, reproducible results.

Chemistry of generic reagents:
- 5x concentrated master mixes for 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 a simple digital workflow and sample tracking
Algorithm for sophisticated rejection of non-PCR artifacts
Absolute quantification without the need for standard curves
Unambiguous thresholding with clear cluster separation of positives and negatives, and very little rain

Bespoke testing with 3 one-of-a-kind nanowell plates^5-8

The unique hexagonal-shaped nanowell partitions and the filling dye that validates partitioning give 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, enabling the detection of rare mutations and allowing for a higher tolerance to inhibitors present in a sample.

Universal plate

30μL, 28,000 partitions
Gene expression
Transplant rejection

High sensitivity

45μL, 20,000 partitions
Cell-free DNA
Oncology, rare mutation detection

High resolution

15μL, 100,000 partitions
Copy number variation
NIPT, Human genetic disease

High sample utilization

Get the most out of your samples with the Digital LightCycler® system's 5x concentrated master mixes.^1-4

Improved sample percentage in each reaction means confidence in results
1 Step RNA (RT) with a hold time of just 15 minutes
Filling dye control that validates partitioning
Single tube
50-75% less primer/probe usage

Simplified workflow with end-to-end sample tracking

The Digital LightCycler® system guides users through a streamlined PCR workflow while enabling sample tracking via its integrated web application.

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.

2. The newly extracted 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.

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.

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

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

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

Automated data management with comprehensive customer support

The Digital LightCycler® Service Software streamlines your lab’s operations by supporting automated workflows and data management. This eliminates the need for external tools to calculate, collate, analyze, and contextualize results—freeing up more time to focus on high-value tasks.

Remote accessible software
Automatic clustering
Full sample tracking
Laboratory Information System interface
Analysis types
- Absolute Quantification
- Indel
- Copy Number Variation

Enables a broad range of high-value applications

The Digital LightCycler® System is built to support a diverse set of advanced research and clinical applications. Its exceptional sensitivity, precision, and ability to perform absolute quantification without a standard curve make it ideally suited for:

Oncology: Enables detection of known specific variants and supports monitoring of treatment efficacy and disease progression
Rare species and variant detection: Offers hypersensitive detection of low-abundance targets without a standard curve
Microsatellite instability (MSI) detection: Enables hypersensitive identification of changes (instability) in microsatellite regions
Pathogen load detection: Delivers absolute quantification of pathogen load without standard curves
Graft rejection monitoring: Measures graft-derived cfDNA for molecular tracking of transplant rejection risk
Environmental surveillance: Maintains high sensitivity and precision even in inhibitor-rich or complex samples, where nucleic acid content may be masked in traditional rtPCR analysis
Large pharmaceutical clinical trials: Supports large volume testing for specific biomarkers with greater accuracy than traditional rtPCR
Noninvasive prenatal testing (NIPT): Improves reliability over conventional antigen tests

Redefining digital PCR testing

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Revolutionize your clinical research! Find out how the Roche Digital LightCycler® System can power your work to achieve reliable and replicable results with confidence.

Show video transcript

There’s a new technology that redefines digital PCR testing. A system designed to be so precise, so sensitive, so effective, it could revolutionize clinical research. Meet the future of digital PCR—the Roche Digital LightCycler® system.

The Digital LightCycler® system’s nanowell plates partition reactions with incredible precision, replicate with ultimate clarity, and still, its power is yet to be unlocked. Your next clinical research discovery could be found with one of three plate types: the 20,000 partition high-sensitivity plate, 28,000 universal partition, or the 100,000 partition high-resolution plate.

These flexible plate options can power your work in absolute quantification, copy number variation, rare mutation detection, and more. What if that’s just the start? Six optical channels, 96 sample capability per run, and the ability to use up to three different nanowell plates within a single run.

The Digital LightCycler System’s category-leading, five-times concentrated master mix allows for up to four times more sample volume per reaction, versus competitors, reducing rain and enabling you to set thresholds easily.

What if you could push the limits of partitioning with the push of a finger? Maximize your workflow and operations on a system created based on inputs from actual researchers. A system that makes light work of rare mutation detection, down to a 0.1 allele fraction.

Achieve reliable and replicable results with ultimate confidence, now imagine bringing it all together in one instrument to unlock never-before-seen clinical and research possibilities.

Stop imagining, the Roche Digital LightCycler® system is here.

Overview

Ordering information

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Product specification	Value
Partitions	20,000, 28,000 or 100,000
Samples	8-96 samples per run
Concentration on MMx	5 x
Channels	6
Total volume	15μL - 45μL

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References

F. Hoffmann-La Roche Ltd. DH_02365.01_031B_Digital_LightCycler_Reagent_Feasibility_Report_v3, Document Number: 000000000000120000050194. Data on file.
F. Hoffmann-La Roche Ltd. DH-02365.01-500E_Digital LightCycler® System Performance report. Data on file.
F. Hoffmann-La Roche Ltd. DHF Digital_LightCycler_Reagent_Feasibility_Report. Data on file.
F. Hoffmann-La Roche Ltd. DH-02365.01-008B_Digital_LightCycler_System_Feasibility_Report. Ltd. Data on file.
QIAGEN. QIAcuity Digital PCR System. [Internet; cited 2025 Apr 01]. Available from: https://www.qiagen.com/us/products/instruments-and-automation/pcr-instruments/qiacuity-digital-pcr-system/
BIO RAD. QX ONE Droplet Digital PCR (ddPCR) System. [Internet; cited 2025 Apr 01]. Available from: https://www.bio-rad.com/en-us/life-science/digital-pcr/qx-one-droplet-digital-pcr-ddpcr-system
STILLA. The naica® system - Multiplex Crystal Digital PCR™. [Internet; cited 2025 Apr 01]. Available from: https://www.stillatechnologies.com/6-color-dpcr/
Thermo Fisher Scientific. QuantStudio™ 3D Digital PCR Instrument with Power Cord. [Internet; cited 2025 Apr 01]. Available from: https://www.thermofisher.com/order/catalog/product/4489084 (last accessed on 08/20/2022)

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