A laboratory partner with global experience for your CDx development
The improvements precision medicine brings to patient outcomes is 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. Q2
Solutions has supported CDx assays for 15 years, and continually enhances its technology, bioinformatics, regulatory, clinical and commercialization aspects. With that depth of experience, our organization has the appropriate structure and attributes to help deliver successful CDx programs.
Extensive CDx track record
Solutions has extensive companion diagnostics experience across the world, including APAC, China, EMEA and US, with generated lab data supporting multiple successful CDx submissions and more than 100 CDx Clinical Trials engagements.
Early engagement with Q2
Solutions’ CDx experts can help circumvent issues during clinical development and provide a line of sight for commercial/post approval assay testing. Early in the co-development process, our experts lead discussions on key topics, such as assay validation versus its intended use and the regulatory paths to enable approval.
Q2 Solutions CDx Experience by Region
Technology breadth for companion diagnostics services
With an extensive instrument footprint in laboratories across the world, Q2
Solutions 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:
||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
A globally harmonized footprint
Most clinical development programs require testing to occur in sites across the globe, and Q2
Solutions has harmonized its CDx SOPs. Our on-site Q2
Solutions 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 Q2
Solutions pathologists are on-site Q2
Global capabilities for CDx studies
- Principal Investigators at each wholly-owned facility
- CDx Training and Harmonized SOPs across global sites
- Global logistics network to route samples into CDx labs for rapid TAT
We work with IVD companies who provide developed assays that we test at our central labs, following verification of performance, and our central labs are qualified by IVD partner companies. In addition, following Installation Qualification (IQ), Operational Qualification (OQ), and Performance Qualification, utilizing a central laboratory that has been previously qualified allows the process to be streamlined through a site initiation visit (SIV) and proficiency training and study start-up.
Principal investigators and study coordinators ensure both compliance to the testing and regulatory requirements, and operational excellence through the delivery of data to clinical sites and study sponsors.
Companion diagnostics solutions: alternative CDx models and the path to approval
CDx projects are often complicated and include significant cost and risk in their development. Q2
Solutions can support different CDx paths including traditional programs with IVD companies to a single-site premarket approval (ssPMA). A critique of the technical, regulatory and commercial clinical diagnostic requirements by Q2
Solutions CDx personnel can direct towards the most appropriate CDx path.
Before approval of a CDx assay, it is good practice to review the options for both the location and distribution of the assay in the clinical diagnostic setting. Q2
Solutions works with its parent organizations to provide several paths available to transition a clinical trial CDx assay to a Clinical Diagnostic Reference Lab Test.
No matter what phase are in your biomarker and companion diagnostics development, Q2
Solutions can partner with you to increase your probability of success.
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for more information.