The improvements precision medicine brings to patient outcomes are both well-known and implemented in clinical practice. Companion Diagnostics (CDx) are assays that are required to be used before a specific therapy can be initiated. They are often co-developed alongside a therapeutic during its clinical development journey. Extensive testing in clinical trials is required, often in multiple sites across the globe. In fact, global solutions are needed due to the increase in clinical development in China and the challenging regulatory conditions on sample import and export. We have supported CDx assays for more than 12 years, and continually enhances its technology, bioinformatics, regulatory, clinical and commercialization aspects. With extensive experience, our organization has the appropriate structure and attributes to help deliver successful CDx programs.
With an extensive instrument footprint in laboratories across the world, we can service CDx requests for protein expression, gene expression, mutation detection, copy number and translocations. Our current experience and focus are with but not limited to following technologies:
Technology | Description |
Immunohistochemistry (IHC) | IHC continues to be a dominant technology |
Next Generation Sequencing (NGS) | Tumor Mutational Burden (TMB) used via relationship with partner Illumina using TSO 500 NGS gene panel |
Quantitative PCR (qPCR) | This is still used; there is movement away from binary biomarkers towards panels |
Most clinical development programs require testing to occur in sites across the globe, and we have harmonized CDx SOPs. Our on-site pathologists are trained across indications and IHC cut-off evaluations by the IVD company for IHC cut-off evaluations, and we dedicate CDx study coordinators and both regional and local project managers on every CDx study. Also, all pathologists are Q2 Solutions employees.
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