Bio-Rad Expands Precision Oncology Research Portfolio with New ddPCR Assays and Advanced Multiplexing Technologies
Bio-Rad Laboratories, a global provider of life science research and clinical diagnostics products, has announced an expansion of its precision oncology research portfolio. The latest additions are designed to give researchers more options for studying cancer-related genetic mutations and developing advanced molecular analysis workflows. The new assays and technologies are intended to support research applications involving mutation detection, liquid biopsy, tumor-informed assay development, molecular residual disease (MRD) research and multiplex biomarker analysis.
The expanded portfolio includes new assays developed for use with Bio-Rad’s QX700™ Droplet Digital PCR (ddPCR™) systems, along with additional mutation detection technologies compatible with the company’s broader QX system family. These solutions are intended to help researchers investigate multiple genetic targets, analyze biomarkers with high sensitivity and develop research workflows suited to different oncology applications. The expansion reflects the growing importance of molecular analysis tools in precision oncology and translational cancer research.
Cancer research increasingly relies on technologies capable of detecting and measuring genetic changes associated with tumor development, progression and treatment response. Researchers need analytical methods that can identify mutations in complex biological samples, including samples containing small amounts of tumor-derived genetic material. Digital PCR technologies provide an approach for studying specific genetic targets through the partitioning and analysis of DNA samples, supporting the measurement of nucleic acid concentrations and the investigation of low-frequency mutations.
Through the expanded portfolio, Bio-Rad aims to provide researchers with additional tools for building flexible and scalable molecular research workflows. The new products cover several areas of oncology research, including targeted mutation screening, multiplex detection and custom assay development. The company said the expanded offering is intended to simplify research workflows while supporting sensitive and quantitative biomarker analysis.
New QX700 Oncology Screening Assays
As part of the portfolio expansion, Bio-Rad has introduced two new screening kits for its QX700 ddPCR systems: the QX700 ddPCR EGFR Exon 19 Deletions Screening Kit and the QX700 ddPCR KRAS G12/G13 Screening Kit. These assays expand the oncology-focused product menu available to researchers using the QX700 platform. They are designed to support research involving mutations in the EGFR and KRAS genes across different solid tumor research applications.
The EGFR gene plays an important role in regulating cell growth and signaling. Changes in this gene, including exon 19 deletions, are studied extensively in cancer research because they can influence tumor biology and treatment-related investigations. Researchers studying EGFR mutations often require analytical methods that can identify specific genetic alterations within complex samples. The new QX700 screening kit is intended to provide a dedicated research tool for investigating EGFR exon 19 deletions using digital PCR workflows.
The KRAS gene is another important focus of molecular oncology research. Mutations affecting KRAS, including changes involving codons 12 and 13, are investigated across several solid tumor types. These mutations can influence cellular signaling pathways and are relevant to studies examining tumor development and molecular characteristics. Bio-Rad’s new QX700 ddPCR KRAS G12/G13 Screening Kit provides researchers with an additional assay option for studying these genetic changes.
Both kits have been optimized for use with the QX700 systems. Their introduction gives researchers access to targeted assays designed around specific mutation categories rather than requiring every research group to develop all screening workflows independently. By expanding the available assay menu, Bio-Rad intends to support a wider range of oncology studies and provide additional flexibility for laboratories conducting molecular analysis.
Dark Probe Technology Supports Mutation Detection Research
Another important part of Bio-Rad’s expanded offering is its Dark Probe Mutation Detection Assays. These assays are compatible with the company’s family of QX systems and are designed to support translational oncology research, particularly applications involving liquid biopsy mutation detection and monitoring. They can be used in research workflows involving liquid samples, molecular residual disease investigations and other studies that require the analysis of specific genetic alterations.
The technology is designed to replace the wild-type fluorescent probe used in existing ddPCR workflows with a quencher-only dark probe. In conventional mutation detection approaches, researchers may need to distinguish a mutated genetic sequence from the corresponding wild-type sequence. Background signal from the wild-type target can affect the ability to identify low-frequency mutations, making signal management an important consideration in assay design.
Bio-Rad’s dark probe approach is intended to suppress wild-type background signal. By reducing the fluorescent signal associated with the wild-type target, the technology can free a detection channel for additional mutation analysis. This design enables researchers to analyze up to four mutation targets in a single well, according to the company. The approach increases multiplexing capabilities while potentially reducing the amount of sample required for certain research workflows.
This capability may be particularly useful in liquid biopsy research, where samples can contain limited quantities of tumor-derived genetic material. Researchers studying circulating tumor DNA may need to investigate multiple mutations while working with restricted sample volumes. Increasing the number of targets that can be analyzed in a single reaction can help laboratories design more efficient experiments and make better use of available research samples.
Dark Probe Mutation Detection Assays are intended to give researchers more flexibility when adapting existing ddPCR workflows. Their compatibility across Bio-Rad’s QX systems also supports the use of the technology within different laboratory setups. The company is positioning these assays as tools for advancing mutation detection research and expanding the range of molecular targets that can be investigated in a single experiment.
CrystalTag Technology Advances High-Plex Molecular Analysis
Bio-Rad is also preparing to introduce 13 oncology-focused ddPLEX CrystalTag ddPCR Assays and CrystalTag Reporters. These products are expected to become available soon and will expand the company’s capabilities in high-plex digital PCR research. The new offerings are based on CrystalTag technology, which separates target recognition from signal generation to provide researchers with greater flexibility in designing multiplex assays.
The technology is designed to enable multiplexed detection of up to 21 targets in a single reaction well on the QX700 platform. This capability could support research projects that require simultaneous investigation of several genetic targets or biomarkers. Rather than analyzing each target in a separate reaction, researchers can use multiplex assay designs to examine multiple targets within one reaction, depending on the experimental requirements and assay configuration.
High-plex analysis is relevant to several areas of oncology and molecular biology research. Cancer samples can contain multiple genetic changes, and understanding their relationships may require the examination of several biomarkers. Researchers conducting biomarker discovery or translational studies may therefore benefit from technologies that allow multiple targets to be assessed within a coordinated workflow.
CrystalTag technology is intended to support the development of customized research assays. By separating the processes of target recognition and signal generation, the approach offers flexibility in how researchers configure their experiments. This design can help laboratories develop workflows around specific research questions, particularly when studies involve multiple targets or require more advanced multiplexing strategies.
The upcoming oncology-focused assays and reporters include solutions for studying ESR1 mutations, KRAS mutations and human papillomavirus (HPV). These targets are relevant to different areas of molecular and translational research. Their inclusion broadens the range of applications that can be investigated using Bio-Rad’s high-plex ddPCR technologies.
Supporting Translational Research and Biomarker Discovery
The CrystalTag-based solutions are intended to support several research areas, including translational research, biomarker discovery, biopharmaceutical research and advanced multiplex assay development. Translational research aims to connect laboratory findings with clinical and biological questions, helping researchers investigate how molecular changes relate to disease processes. Sensitive and flexible analytical tools can contribute to this work by enabling the measurement of specific genetic targets in research samples.
Biomarker discovery is another area where multiplex molecular analysis can be useful. Researchers often investigate several potential biomarkers to understand their relationship with disease characteristics or biological responses. Technologies that allow multiple targets to be measured in a single reaction may help laboratories explore complex biomarker panels and develop more comprehensive research strategies.
In biopharmaceutical research, molecular analysis tools can support investigations into biological mechanisms, therapeutic development and the evaluation of research samples. The ability to measure multiple genetic targets may provide additional information for studies examining disease pathways or treatment-related changes. Bio-Rad’s expanded portfolio is designed to accommodate these types of research applications through a combination of targeted screening assays, dark probe technology and high-plex CrystalTag solutions.
The availability of customizable assay technologies is also relevant to laboratories with specialized research requirements. Different studies may focus on different mutations, biomarkers or sample types. A flexible platform can help researchers adapt their assay configurations to the objectives of individual projects while maintaining a consistent digital PCR workflow.
Digital PCR and the Role of Sensitive Biomarker Analysis
Droplet Digital PCR is a molecular analysis technology that partitions a sample into many individual reaction droplets. Following amplification, the droplets are analyzed to determine the presence and quantity of specific nucleic acid targets. This partitioning approach enables researchers to perform absolute quantification without relying on a standard calibration curve in the same way as some conventional quantitative PCR methods.
In oncology research, digital PCR can be used to investigate mutations that may be present at low levels within a sample. This is particularly relevant to liquid biopsy research, where tumor-derived DNA may represent only a small proportion of the total circulating DNA. Sensitive detection methods can help researchers study these genetic changes and explore how they may relate to cancer biology or treatment response.
Molecular residual disease research is another area where sensitive molecular analysis is important. MRD research focuses on investigating whether small amounts of disease-associated material remain after treatment or during disease monitoring. Researchers use different molecular methods to study these signals and evaluate their potential significance. Bio-Rad’s expanded assay portfolio is intended to support research workflows in this field, including the development and evaluation of mutation detection strategies.
The company’s new assays and technologies provide options for different levels of research complexity. The EGFR and KRAS screening kits are focused on specific mutation categories, while Dark Probe Mutation Detection Assays are designed to increase multiplexing opportunities within existing workflows. CrystalTag technology adds another layer of flexibility by supporting high-plex analysis of up to 21 targets in a single reaction well on the QX700 platform.
Bio-Rad Highlights Its Commitment to Oncology Research
Steve Kulisch, Vice President of Product Management for Bio-Rad Laboratories’ Digital Biology Group, said the expanded QX700 ddPCR assay menu and technologies will help researchers design more powerful multiplex assays and analyze biomarkers with sensitive, absolute quantification. He also highlighted the company’s focus on scalable and streamlined research workflows.
Kulisch said the launch, together with Bio-Rad’s continued investment in CrystalTag technology, demonstrates the company’s commitment to advancing oncology research. The expanded portfolio is intended to give laboratories additional options for studying mutations and biomarkers while supporting the development of more complex molecular assays.
The company’s strategy brings together targeted mutation screening, improved multiplexing and flexible assay design. These capabilities address different research needs, from investigating specific mutations to developing customized panels involving multiple genetic targets. By expanding its product portfolio across these areas, Bio-Rad is seeking to support researchers working on increasingly complex molecular questions.
The announcement also reflects broader developments in precision oncology research. As scientists investigate cancer at the molecular level, laboratories require tools that can provide detailed information about genetic changes and biomarker patterns. Assays that support sensitive detection and efficient multiplexing can contribute to these investigations, although the selection of an appropriate method depends on the research objectives, sample characteristics and validation requirements.
Research Use Only and Product Information
Bio-Rad has stated that the ddPCR assays manufactured by the company are intended for Research Use Only (RUO) and are not intended for use in diagnostic procedures. This distinction is important because the products described in the announcement are research tools and should not be interpreted as approved clinical diagnostic tests.
Any clinical use or clinical claims made by customers or researchers must undergo their own in-house validation and comply with applicable local regulations. Laboratories and research organizations must therefore follow relevant regulatory requirements when determining how these assays may be used in their specific research environments.
Researchers interested in learning more about the expanded portfolio can visit Bio-Rad’s digital PCR portfolio website. The company’s broader offering includes digital PCR instruments, consumables and assays designed to support different molecular research applications.
Expanded Portfolio Offers More Options for Molecular Oncology Workflows
Bio-Rad’s latest portfolio expansion brings together new QX700 oncology screening kits, Dark Probe Mutation Detection Assays and upcoming CrystalTag-based solutions. The products are intended to support research into EGFR and KRAS mutations, liquid biopsy workflows, molecular residual disease, biomarker discovery and high-plex molecular analysis.
The new QX700 screening kits provide dedicated tools for investigating EGFR exon 19 deletions and KRAS G12/G13 mutations. Dark Probe technology is designed to reduce wild-type background signal and support the analysis of up to four mutation targets in a single well. Meanwhile, CrystalTag technology is expected to enable multiplexed detection of up to 21 targets in one reaction well on the QX700 platform.
Together, these additions broaden the research options available to laboratories using Bio-Rad’s digital PCR systems. The company aims to help researchers develop more flexible assay designs, improve sample-use efficiency and conduct sensitive molecular analysis across a range of oncology research applications. With its continued investment in digital PCR and CrystalTag technology, Bio-Rad is strengthening its position in the tools and technologies supporting precision oncology research.
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