Simplify your clinical testing

A technology that’s revolutionizing clinical testing

What is digital PCR (dPCR)? Whether you’d like to brush up on your background knowledge or explore for the first time the fundamentals of a technology for the absolute quantification of nucleic acid concentrations, we’ve got you covered. Learn all you need to know about dPCR here.

What are the features and benefits of dPCR for diagnostic testing?

What are the main applications for dPCR in molecular diagnostics?

Cancer biomarker detection

dPCR's high sensitivity and precision make it an invaluable tool for reproducible and reliable detection of cancer biomarkers at low analyte concentrations. This is particularly significant for identifying driver mutations and developing personalized treatment plans where applicable.

This feature is also important for monitoring treatment effectiveness, where the goal is to establish if there is a change in molecular expression and prevalence of biomarkers after treatment has been initiated.

Monitoring and MRD testing

Due to its high precision and absolute quantification features, dPCR is a valuable tool for monitoring the molecular response in oncology patient samples after initiating a targeted therapy. Sequential biomarker monitoring across multiple time points can provide useful data, alongside other clinical findings, that provide information about patient response to treatment and potential relapse.

Specifically within oncohematology, these features are valuable for minimal residual disease testing (MRD testing) for applications such as BCR::ABL in chronic myeloid leukemia (CML). Absolute quantification removes the need to produce a standard curve for quantitation reference, allowing more efficient use of plate wells and chemistry versus qPCR (3, 4).

Liquid biopsy

The non-invasive nature of liquid biopsy combined with the sensitivity of dPCR makes it a promising approach for diagnosis and monitoring treatment response and disease progression through the analysis through the analysis of circulating nucleic acids in body fluids. Liquid biopsy adds the potential for serial testing of patients where frequent tissue biopsies are not feasible (e.g., lung cancer).

Infectious disease diagnosis

For infectious diseases, dPCR is pivotal in identifying pathogens with low copy numbers and for applications where absolute quantification of the target provide valuable information. This is essential for accurate diagnosis and timely intervention, particularly in infectious disease applications.

Genetic testing and rare variant detection

dPCR excels in identifying rare genetic variants, contributing to the advancement of genetic testing. Its ability to quantify specific DNA sequences at low analyte concentration with high precision is instrumental in identifying rare genetic events and predispositions.

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Why choose digital PCR for molecular diagnostics?

Why choose dPCR for molecular diagnostics?

Precise: Achieve precise quantification of nucleic acids, enabling researchers and clinicians to confidently interpret results.
Reliable: dPCR provides accurate and reliable results, critical for informed decision-making in clinical and research settings.
Broad scope of applications: With applications spanning from oncology to infectious diseases, dPCR offers flexibility in addressing a range of diagnostic challenges.
Innovative: Stay at the forefront of molecular diagnostics by incorporating the latest technological advancements into your diagnostic workflows.

Out with the old, in with the new in molecular diagnostic testing

Clinical labs are increasingly under pressure to process a high volume of ready-to-run IVD and self-developed tests. The needs for molecular testing for personalized medicine in oncology are predicted to continually grow (5), based on many factors. These include aging populations, increased licensing of targeted therapies and developments in both the fields of oncology population screening (multi-cancer early detection) and minimal residual disease testing (MRD testing) in oncohematology. Clinicians depend on testing results to guide their decisions, so labs need to deliver results fast.

The problem is that many labs are burdened by complicated, manual steps and long workflows that involve multiple machines that require specialized personnel to run. But complex and clunky workflows aren’t sustainable as needs continue to grow and labs are expected to deliver more with fewer resources.

Out with the old, in with the new in molecular diagnostic testing

Quick and easy workflow

Testing labs are under pressure to do more with less. Deliver more tests quicker, with fewer resources and expertise.

To better balance the high demand for diagnostic testing with the need for quick results, labs need a shorter and simpler workflow that’s easier to run. The QIAcuityDx is a single touchpoint, benchtop system that’ll save labs time, space and deliver results faster than other available dPCR workflows. It’s got a quick, simple and easy-to-run qPCR-like workflow. It’s all a lab needs, in just one machine.

Nanowells enhance precision and sensitivity

QIAcuityDx is a single-instrument workflow utilizing physical nanoplates. The partitioning step is fully automated within the machine, effortlessly distributing the sample into 26,000 nanowells. Nanowells offer high precision by isolating individual reactions, ensuring accurate quantification of target molecules. This enhances sensitivity, minimizes background noise and enables high throughput analysis, making it a game-changer in molecular diagnostics and translational research. The automated workflow means lab personnel only has to prepare the dPCR reactions, seal the plate and run with the partitioning. PCR cycling and analysis occur automatically within the instrument without the need for user intervention. This reduces hands-on time when compared to workflows that require off board partitioning or droplet generation, allowing laboratories to utilize lab personnel resources more efficiently.

dPCR simplified with QIAcuityDx

Using QIAcuityDx, it’s easy to simultaneously run multiple plates with different settings, and continually remove and load new plates. So busy labs like yours can quickly adapt to changing needs. For labs that need to run their own developed assays, QIAcuityDx Utility Mode and IVD off-the-shelf consumables give you a streamlined and simplified route to develop and run your own assay menu using a single platform. When compared to other dPCR workflows QIAcuityDx represents a simpler process, so lab operators can invest less valuable time setting up the machine to deliver results.

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References:

Madariaga RS, Gallego GB, Santana FR, Sperança MA. Comparison of real-time PCR and digital PCR in environmental microbial quantification: A review study. Anal Chem Insights 2018;17(3):123–134.
Nguyen HT, Jeong KJ, Cha CY, Shin K, Kim H, Choi HJ. Comparison of real-time PCR and digital PCR in detection of enteroviral RNA in clinical samples. J Virol Methods 2017;246:34–40.
Tan HH, Chia KS, Chng WJ, Lim ST. Quantitative analysis of BCR-ABL1 transcripts in patients with chronic myeloid leukemia using digital PCR. J Mol Diagn. 2014;17(3):123–134.
Albitar M, et al. Comparison of next-generation sequencing and quantitative real-time PCR for minimal residual disease testing in acute lymphoblastic leukemia. Clin Lymphoma Myeloma Leuk. 2021;17(3):123–134.
Molecular Diagnostics Market Size, Share & Trends Analysis. November 24, 2023 https://www.linkedin.com/pulse/molecular-diagnostics-market-size-share-trends-analysis-hancock-evxbf/ (Accessed January 25, 2024).

The QIAcuityDx medical device is currently under development and will be available in 20 countries in H2 2024. Product availability may vary by country specific regulatory requirements and approvals. Contact your country representative or visit www.qiagen.com for further details.

QIAcuity Digital PCR instruments are sold under license from Bio-Rad Laboratories, Inc. and exclude rights for use with pediatric applications.