Genomic Assays for Clinical Development

Author:
Patrick Hurban, Ph.D., Global Head, Senior Director, Translational Genomics, IQVIA Laboratories

Choosing the right genomic assays from a wealth of potential options stands as one of the most influential decisions for the success of a development project. 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.

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