Q2 Solutions Q2 Solutions Actionable Insights for Better Health and Lab Solutions
Insight Brief
Patrick Hurban, Ph.D. | April 11, 2017

Genomic Assays for Clinical Development

Identifying the right approach from a wealth of potential options
Finding the right match for a project’s requirements results in a smoother, more informed and efficient process, while the wrong assay – one that is less efficient or one that is not fit-for-purpose – leads to wasted time and money and can delay delivery of important medications to waiting patients.

Biomarker and assay selection needs change as we progress through the clinical development continuum. In very early discovery and development, the focus is on hypothesis-driven and broad-based biomarker discovery goals. As the trial progresses, biomarker-driven safety and patient stratification take center stage until finally, a targeted companion diagnostic (CDx) might be developed. Similarly, the focus for assay development changes, beginning with broad screening assays during early development and shifting to more targeted sequencing or qPCR-based approaches that more readily lend themselves to laboratory developed tests (LDTs) or in vitro diagnostics (IVDs) later in the program when regulatory requirements are critical concerns.  

Download this insight brief to learn more about different genomic assays that can be used during clinical development and which ones are right for your study.
Genomic Based Solutions for Your Immuno-oncology Drug Development Needs

Genomics-based biomarker approach

New Opportunities for Immuno-oncology Clinical Development Programs through T cell/B cell Repertoire Profiling

Immune repertoire profiling provides better outcomes for immuno-oncology development programs

Translating Data into Insights with Bioinformatics

Best Practices for Integrating Biomarkers across the Drug Development Continuum

A roadmap for a successful biomarker strategy

Read More