Droplet Digital PCR
Goes Clinical*

Any Lab, Any Instrument, Any Operator — Same Result

*For researchers & clinical labs that use the FDA Cleared QXDx BCR-ABL % IS Kit

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Discover ddPCR

Droplet Digital PCR provides highly sensitive absolute quantitation of DNA or RNA in serum, plasma, tissue or urine samples along with unrivaled precision and reproducibility, without the need for standard curves. ddPCR has expanded beyond research applications and has moved into clinical laboratories.

Over 900 publications describe the use of Droplet Digital PCR in clinical research applications. View the full list here

Choose between the QXDx System which offers both IVD and research modes and the QX200 System, which is for research use only (RUO).

  QXDx (IVD) QX200 (RUO)
Description The QXDx AutoDG ddPCR system is FDA cleared (with the QXDx BCR-ABL %IS Kit). This system was built with flexibility in mind enabling users to run IVD menu and develop LDTs on a single instrument. The QX200 ddPCR system provides absolute quantitation of target DNA or RNA molecules for EvaGreen or probe-based research use only digital PCR applications.
Regulatory Status FDA Cleared
CE/IVD
Research Use Only
(Not for diagnostic use)
IVD Assay Menu QXDX BCR-ABL % IS Kit
Future Bio-Rad IVD menu
Future Partner IVD menu
Not available
Emergency Use Authorizations SARS-CoV-2 ddPCR Kit SARS-CoV-2 ddPCR Kit
RUO Applications Same as QX200 Mutation Detection
Copy Number Variation
Absolute Quantitation
View the full list here
Software Options QXDx Acquisition Software
QXDx Analysis Software
QX Developer
All RUO software options
QX Manager
QX Manager Regulatory Edition

Oncology

Droplet Digital PCR provides highly sensitive absolute quantitation of DNA or RNA in serum, plasma, tissue or urine without the need of a standard curve. This is achieved by partitioning a sample into thousands of separate DNA or RNA molecules within nano-liter sized droplets. Each droplet can then be directly detected or quantified with unmatched sensitivity and precision.

With a fast turn-around time and low sample cost, Droplet Digital PCR is ideal for liquid biopsy applications including precise copy number analysis, sensitive rare mutation detection and accurate gene fusion quantitation. Droplet Digital PCR also works well for single-gene biomarker quantitation.

Click here to browse peer-reviewed publications that have advanced liquid biopsy with Droplet Digital PCR.

Next-Generation Sequencing Orthogonal Confirmation

Next-generation sequencing (NGS) has experienced rapid adoption by clinical laboratories for the simultaneous detection of multiple gene targets. With this expansion into clinical labs, especially for the use in molecular oncology, various organizations have published guidelines to ensure the accuracy and quality of NGS data used in patient care.

Recently, Droplet Digital PCR has emerged as the gold standard for NGS orthogonal testing due to the ability to precisely detect copy number variations and sensitively quantify variant allele frequencies.

Learn how your colleagues are using ddPCR to confirm their NGS results. Recommended Reading

Newborn Screening & Carrier Testing

The recent addition of Spinal Muscular Atrophy (SMA) to the Recommended Universal Screening Panel has highlighted the utility of Droplet Digital PCR laboratory developed tests (LDTs) for newborn screening.

SMA is an autosomal recessive disorder that is caused by deletions in the survival motor neuron gene 1 (SMN1) resulting in neurodegeneration and progressive muscle atrophy and ultimately respiratory failure. SMA disease severity is correlated with the individuals SMN2 gene copy state (ranging from 0-4+ copies).

It’s also important to note that the American College of Obstetricians and Gynecologists recommends that all pregnant women or those considering pregnancy should be offered screening for SMA.

The precision of Droplet Digital PCR makes it an ideal technology to accurately discriminate copy number states when compared to other molecular methods such as qPCR and NGS.

ddPCR (left) and qPCR (right) measurements of MRGPRX1 copy numbers across seven Coriell DNA samples. The partitioning of ddPCR enables fine quantitative discrimination required to resolve copy number states with confidence.

Learn how your colleagues have implemented ddPCR for SMA testing and newborn screening.

Have questions? Speak with a ddPCR expert ▸