For in vitro diagnostic use. System Digital LightCycler system IVD 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

Semi-automated system for the detection and absolute quantification of nucleic acid target copy number during Polymerase Chain Reaction (PCR) based Nucleic Acid Testing (NAT).

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Make the leap from idea to impact

It's time for a leap forward in digital PCR technology. 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 to make the leap from publishing research to producing clinically viable assays.

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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

Digital LightCycler^® System Video

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Bespoke testing with 3 one-of-a-kind^1-4 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.

High Resolution

15μL, 100,000 partitions

Copy Number Variation

NIPT

Human Genetic Disease

Universal Plate

30μL, 28,000 partitions

Gene Expression

Transplant Rejection

High Sensitivity

45μL, 20,000 partitions

Cell-free DNA

Oncology

Rare Mutation Detection

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 5x 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

Simple workflow and data tracking

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.

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

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

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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	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

Clear cluster separation of positives and negatives
Very little rain

Roche Digital LightCycler^® System

Competitor A

Competitor B

A wide range of research possibilities

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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 without a standard curve

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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

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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* 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

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

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