Partner for IVD biomarker assay development on QIAcuityDx

Let's partner to develop your dPCR assays on QIAcuityDx

Imagine having the ability to develop and run your own biomarker assays on a powerful and versatile digital PCR (dPCR) instrument. Wouldn't it be great if you could simplify the usability of your biomarker assay and ensure regulatory compliance, without the hoops and hurdles? Now's the time to transform your biomarker assays for applications like oncology and infectious disease to run on our QIAcuityDx Four dPCR instrument.

Wondering what the difference is between dPCR and qPCR? Or how nanoplate dPCR measures up versus digital droplet PCR (ddPCR)? Here you can explore a comparison of different dPCR methods.

Contact us about converting your assay to run on QIAcuityDx Four

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A flexible partnership for your IVD assay development

We have flexible models to help your company develop, validate, register, document and commercialize your dPCR assays. Our partnering option menu adapts to your molecular diagnostics assay development needs.

Why choose digital PCR for molecular diagnostics?

Simple licensing agreement
Supply agreement for universal components
Optional support agreement for design or regulatory support services for your non-clinical laboratory research use assay or IVD medical device assay
Scalability enabled by good manufacturing practice (GMP) production processes and standards that support you in moving from research-scale experiments to large-scale production without compromising quality
Leverage our sales and marketing team for co-marketing and promotion opportunities for global distribution and commercialization

We make sure your company feels empowered with multiple partnering options, flexible models and access to our expertise in assay development. Your company could benefit by accelerating innovative IVD assay development and accessing global customers and stakeholders.

Convert your assay into an IVD device

If you're like many test kit developers, you may have developed tests using qPCR in the past. You might even have biomarker assays you've developed using non-IVD dPCR instruments from our QIAcuity family, or providers such as Bio-Rad.

We can help your company transfer your assay, initially via the open Utility Mode on our QIAcuityDx dPCR instrument, and when the time is right for your business, to the locked IVD Mode. This would allow you to run your clinically validated IVD assays in the IVD environment of our QIAcuityDx system.

Secure a diagnostic future for your research assay

If you're company is looking to develop diagnostic tools, we can help you transition your assay for non-clinical laboratory research purposes towards an IVD medical device assay.

Our support extends from initial development to clinical validation, providing the necessary infrastructure and expertise to meet rigorous diagnostic standards. Together, we can transform your assays into reliable diagnostic tools that impact patient care globally.

QIAcuityDx, QIAcuity Dx, MDx, diagnostic, instrument, TSPDx, dPCR

Take the next step

Explore the possibilities of biomarker assay development in an IVD environment on the QIAcuityDx Four instrument. You'll gain the benefits of using an IVD medical device instrument and consumables and our QIAcuityDx instrument install base. We can partner to create custom analytics packages that fit your needs.

"Partnering with us for biomarker assay development on our state-of-the-art QIAcuityDx IVD dPCR medical device platform ensures you leverage our cutting-edge technology, successful history of flexible partnerships and expertise in molecular diagnostics. Our platform enables your assays to deliver accurate and actionable results. By collaborating with us, you gain access to our innovative technology, commercial services and regulatory support services, empowering your company and accelerating your path to market success."

Jonathan Arnold, Vice President of Molecular Diagnostics, QIAGEN

Contact us to convert your assay into an IVD test for QIAcuityDx

We'll ensure it complies with the most recent regulations on in-house developed assays.