Multi companion diagnostic (CDx) validation is crucial for advancing precision medicine in global drug development. By verifying that diagnostic tests accurately identify patients likely to benefit from specific treatments, CDx validation enables targeted therapies and personalized medicine. This process often involves validating multiple assays that detect distinct biomarkers, each linked to different therapeutic approaches or disease subtypes. When done effectively, this multi-CDx validation contributes to better patient stratification, streamlined clinical trial execution and improved regulatory alignment across regions.
The need to validate multiple CDx assays
A global pharmaceutical sponsor initiated a Phase III multi-regional clinical trial (MRCT) for a combination therapy targeting HER2 and PD-1 in solid tumors. The program required validation of three distinct CDx assays across three platforms, each with unique assay methodologies and regulatory expectations.
The sponsor faced four major hurdles
- Technical complexity: Transferring three CDx assays simultaneously across international sites demanded precise coordination and deep assay knowledge
- Regulatory variation: Each region had distinct requirements for validation, which added layers of planning and documentation
- Operational risk: Any delay in assay readiness could disrupt trial timelines and impact downstream development milestones
- Perception gap: Many sponsors view assay transfer as a routine task, but the intricacies of multi-CDx validation in a global context require a more strategic and structured approach. This complexity is amplified when multiple sponsors are involved in biomarker detection, as secure data transmission and maintaining necessary blinding without delaying timelines, adding significant operational challenges
Labcorp’s approach to multi-CDx validation
Labcorp partnered with the sponsor to accelerate assay transfer and validation by activating its global infrastructure, deploying harmonized processes and applying a coordinated operational model. The goal was to deliver consistent assay performance across all sites while aligning with regional regulatory expectations.
Key actions taken
1. Global APH network activation
Labcorp mobilized its anatomic pathology and histology (APH) teams across North America, Europe and Asia-Pacific. This centralized training ensured all sites passed tests under consistent evaluation standards. Training was led by a designated trainer from the IVD sponsor team. This approach supported uniform assay interpretation and execution across sites.
2. Deployment of harmonized SOPs
Labcorp applied standardized operating procedures (SOPs) tailored to each CDx assay. These SOPs were created based on corresponding CDx documents/internal criteria and could be drawn from an internal library, allowing for consistent assay performance and data comparability across labs.
3. Centralized project management
A dedicated global project manager oversaw timelines, logistics and communication across all sites. This centralized coordination helped reduce friction, streamline decision-making and maintain transparency throughout the validation process. Highlighted in this process was the Diagnostic Development Service (DDS) team and its critical role in facilitating collaboration among the central lab, IVD sponsor and pharma sponsor.
Collaborative outcomes and client benefits
Labcorp’s strategic and collaborative involvement enabled the sponsor to overcome complex regulatory requirements and logistical hurdles efficiently. Providing support with multi-site assay transfers, reducing timeline risks, and cross-regional coordination while consolidating multi-biomarker detection tests within Labcorp helped reduce sample transport costs, minimize sample usage, enable integrated analysis, and accelerate overall project progress, enabling a successful multi-CDx validation across global sites. The collaboration resulted in:
Accelerated validation timelines: All three CDx assays were validated within the sponsor’s target window, supporting timely trial initiation
Compliance with regulatory requirements: The sponsor achieved consistent validation across multiple international sites, maintaining compliance with regional regulatory requirements, with Labcorp effectively managing communication and logistics across its global laboratory network
Data consistency: High-quality, reproducible assay results were delivered across platforms and geographies
Conclusion
Labcorp’s engagement helped the sponsor recognize the strategic value of robust assay transfer in global trials. Labcorp’s extensive experience in CDx programs, supporting over 200 global initiatives since 2015, positions it as a trusted partner in MRCTs. With one of the industry’s largest SOP repositories and a proven track record in FDA- approved CDx applications, Labcorp offers comprehensive trial support that extends beyond assay validation.
Labcorp delivers tailored solutions that meet sponsor needs. This case study demonstrates how Labcorp’s collaborative approach can benefit future clients seeking reliable and strategic CDx validation. As precision medicine evolves, Labcorp continues to innovate in CDx validation to support global drug development.