ddPCR Certified Kit Provider Program

Partner with Bio-Rad for Molecular Diagnostics Development

Advance precision oncology, accelerate IVD development, and achieve global commercialization

Partnering with Bio-Rad for ddPCR Test Kit Development

Bio-Rad partners with test kit providers to develop Droplet Digital™ PCR (ddPCR) assays and diagnostic test kits. We help kit manufacturers to develop and commercialize IVD and registered ddPCR test kits using our Droplet Digital PCR platform. We can help you with assay design, in-licensing, co-development, and co-marketing opportunities.

For Developers of IVD and Registered ddPCR Kits

The ddPCR Certified Kit Provider Partnership Program enables kit producers to partner with Bio-Rad scientists to develop and commercialize new ddPCR assay test kits for our Droplet Digital PCR platform, which impacts life science research and clinical applications with a decentralized solution.

We can help you develop, validate, register, document, and commercialize new ddPCR test kits, with flexible partnering solutions to best suit your molecular diagnostics kit development needs:

Simple licensing agreement
Supply agreement for universal components
Optional Support agreement for custom assay design or regulatory support services

We strive to empower our partners with multiple partnering paths, flexible models, and our expertise in assay development. Your company benefits by accelerating your time to revenue in offering your innovative tests to your customers.

Partnership Benefits

Simple, flexible, and customer focused process
Proven experience and deep expertise to help advance your clinical research with cutting-edge diagnostic tests — from design to validation, regulatory approval, and manufacturing
Co-marketing and promotion approaches with our partners to support your world-wide distribution and commercialization

Droplet Digital PCR Benefits

Digital PCR represents a third generation of PCR that enables absolute quantification of target sequences

Absolute quantification without standard curves
Unparalleled precision with high reproducibility
Superior sensitivity with high inhibitor tolerance

QxDx ddPCR System for In Vitro Diagnostics (IVD)

Low-burden workflow; same-day turnaround
Cost-effective testing - multiplex targets in a single well
Global installed base of Droplet Digital PCR Systems
QXDx ddPCR System is FDA and CE-IVD cleared

Droplet Digital PCR Assay Options

Bio-Rad has developed a comprehensive library of digital PCR assays for translational research. Explore our current Digital PCR assays, or contact us to learn about custom design options to meet your needs.

Ready-to-Use ddPCR Assays

Explore our portfolio of ddPCR assays, predesigned and validated or designed online for you in seconds.

Applications of ddPCR Assays in Molecular Oncology

The use of ddPCR assays to directly quantify rare molecules such as cell-free cDNA (cfDNA) in clinical samples within complex matrices has significantly advanced the abilities of researchers and clinicians for precision medicine in oncology and hematology.

Key applications include therapy monitoring in cell and gene therapy, minimal residual disease (MRD) monitoring, and liquid biopsy to quantify circulating tumor DNA (ctDNA) and circulating tumor cells (CTCs) for cancer detection and monitoring.

Decisive Moments in Precision Medicine are Revolutionizing Care

Compare qPCR, NGS, and ddPCR technologies in cost, turnaround time, and sensitivity in near–real-time monitoring of treatment response to solid tumors by liquid biopsy.
Droplet Digital PCR Tools for Hematology-Oncology

Expand your MRD testing capabilities and improve patient care with the power of ddPCR Systems and assays for precision monitoring.
Droplet Digital PCR Provides High-Sensitivity for Liquid Biopsy

Our ddPCR assays enable liquid biopsies in the areas of cancer diagnosis, monitoring, evaluation of treatment modalities, and testing for reoccurrence after remission.

Join our Licensed Diagnostics Kit Partners

ddPCR Assay Development for Commercial Service Labs

Bio-Rad partners with commercial service labs to develop new ddPCR assays using Bio-Rad’s Droplet Digital PCR platform, which has a wide range of life science research and clinical applications, especially in the precision oncology space. Bio-Rad does not require a commercial use license to run ddPCR assays in a service lab.

For CLIA and Diagnostic Labs Offering ddPCR Assays as a Service

We offer assistance in expanding your ddPCR assay menu with custom and off-the-shelf assays. We can help you with menu expansion, assay design with flexible partnering solutions to best suit your molecular assay development needs:

No license needed
Supply agreement for custom products
Optional Support agreement for custom assay design or regulatory support services

Droplet Digital PCR Systems and Assays

Digital PCR Systems, Software, and Consumables

Choose from the basic QX200 System, the QX200 AutoDG (auto droplet generation) System, or the new hands-free, fully-integrated QX ONE System.
Digital PCR Assays and Kits

Explore our portfolio of precision monitoring RUO assays for mutation detection, copy number variation, residual DNA quantification, and more.
Digital PCR Hematologic Cancer Assays for MRD Assessment

Monitor cancers with digital PCR, a highly sensitive and precise tool for MRD that provides reproducible results by absolute quantification not reliant on standards.

Resources

Introduction to Digital PCR

See Digital PCR and its significant benefits over other PCR methods: absolute quantification without a standard curve and enhanced sensitivity and dynamic range.
Applications of Digital PCR

Learn how breakthrough digital PCR technology is used to provide ultrasensitive and precise nucleic acid quantitation in a wide range of research and diagnostic applications.
Droplet Digital PCR (ddPCR) Technology

Review Bio-Rad’s Droplet Digital PCR technology, how it works, and the advantages of ddPCR assays vs. other PCR methods.