IVD Assay Development

Molecular diagnostics are evolving rapidly, driven by advances in precision medicine, regulatory standards, and the demand for reproducible, high-performance assays. You need innovative solutions that enhance efficiency, accuracy, and adaptability to stay ahead.

With the QXDx ddPCR platform, you can confidently navigate these changes—whether adopting liquid biopsy for non-invasive cancer detection, standardizing assays to meet regulatory demands, or leveraging multiplexing for comprehensive biomarker analysis.

Explore how the QXDx platform helps you adapt to these evolving industry trends, ensuring precision, efficiency, and scalability for your IVD assay development.

Explore the QXDx ddPCR Platform

Shift to Liquid Biopsy-Based Diagnostics

Liquid biopsy methods are transforming oncology diagnostics by enabling non-invasive testing for cancer biomarkers like ctDNA. They offer safer, faster, and more efficient alternatives to traditional tissue biopsies, making them attractive for modern oncology workflows.

• Detect low-abundance biomarkers with exceptional sensitivity and precision for liquid biopsy applications, enabling more sensitive disease monitoring.
• Identify cancer mutations and resistance markers accurately to support timely, data-driven decisions.
• Develop custom assays efficiently with the QXDx Universal ddPCR Kit, designed for minimal sample volume while maintaining robust and reproducible results.

Learn More About the QXDx Universal Kit

Regulatory Emphasis on Standardization

Standardization of methodologies and reporting formats is clearly needed to ensure consistency across laboratories. Frameworks like the International Scale (IS) for BCR-ABL monitoring drive the global push for reliable and reproducible IVD applications.

• Ensure highly reproducible results across different runs and sample types, meeting regulatory expectations for accuracy and reliability.
• Reduce variability to comply with stringent IVD assay development standards, ensuring precision in clinical applications.
• Seamlessly transition from exploratory research to streamlined clinical applications with user-friendly, standardized workflows.

Explore the QXDx AutoDG ddPCR System

Need for Multiplexing Technologies

The advanced multiplexing capacity of ddPCR technology enables the simultaneous detection of multiple biomarkers from a single sample. This innovation reduces time, costs, and input requirements, optimizing workflows while delivering comprehensive data critical for precision oncology.

• Detect multiple biomarkers in a minimal sample with high precision and efficiency, enabling more informative IVD applications.
• Expand your content offerings with the Universal ddPCR Kit, providing customizable assay designs for increasing clinical applications.
• Maximize resources and accelerate results with integrated, high-throughput workflows designed for efficiency and reliability.

Explore the QXDx ddPCR Platform

Expansion of Companion Diagnostics

The growing demand for targeted therapies has accelerated the need for companion diagnostics. These precision tools ensure the right treatment reaches the right patient by detecting key biomarkers linked to therapeutic response.

• Detect critical mutations in target genes like EGFR, KRAS, BRAF, PIK3CA, NTRK, and RET with exceptional accuracy, enabling precise patient stratification.
• Develop high-performance companion diagnostic assays that provide critical insights for, data-driven therapeutic decisions.
• Create cost-effective IVD applications that deliver same-day results and are capable of accelerating decisions.

Learn More About Our QXDx ddPCR Portfolio