New all-in-one IVD digital PCR

QIAcuityDx: Clinical dPCR reinvented

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 (1), 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.

Meet QIAcuityDx

QIAcuityDx: A single dPCR instrument with a simple and time-saving workflow

Our new single digital PCR instrument for IVD applications is all your clinical ab needs in just one machine. It'll save you time, space and get you results fast. Its quick and simple qPCR-like workflow seamlessly integrates partitioning/processing, PCR and analysis to reduce hands-on time.

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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.

Learn how QIAcuityDx can simplify your clinical testing workflows

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Assay development

Easily develop your own custom assay menu

For customized dPCR assay workflows, QIAcuityDx has a utility (open) mode that lets you build your own laboratory developed workflows using IVD medical device consumables, reagents and software*.

The utility mode is an open ‘development mode’. It is regularly updated with new features and has adaptable run and analysis parameters. When using utility mode, labs can choose to use reagents and nanoplates meant for research use, or our QIAcuityDx medical device consumables and reagents.

Workflow

Boost efficiency with streamlined lab developed test workflows using QIAcuityDx

Who doesn't love a quick and simple workflow? Even better, one that's automated.

If your lab runs in-house developed tests, you can incorporate one of our streamlined and efficient end-to-end workflows using QIAcuityDx utility (open) mode. The outcome: Reliable results for a variety of cancer and infectious disease applications, and time saved in the lab.

Have you heard of our customized services to design the right workflow for your lab's needs? Our team of experts offers services to help you with assay transfer, optimize your workflows and design custom assays.

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Want to see how one of our complete workflows using QIAcuityDx utility (open) mode comes to life?

Read our white paper to explore an end-to-end, in-house developed dPCR assay workflow for cancer mutations.

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Customer stories

Your QIAcuityDx playlist: Tutorials, customer stories and more

Dig into the many ways happy customers use QIAcuityDx to build efficiency into their lab workflows.

Learn about the nuts and bolts of the QIAcuityDx workflow. We've got a variety of videos sure to pique your interest.

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Featured resources – information to support your work

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References:

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).

* FDA 'Medical Devices; Laboratory Developed Tests' final rule, May 6, 2024 and European Union regulation requirements on 'In-House Assays' (Regulation (EU) 2017/746 -IVDR- Art. 5(5)).

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

Product availability may vary by country specific regulatory requirements and approvals. Contact your country representative or visit www.qiagen.com for further details.