Integrated Biomarker Testing Drives Precision Oncology Development

Biomarker testing is revolutionizing targeted and immunotherapy development in oncology, offering a pathway to accelerate research, improve patient stratification, and reduce trial risk. As the pharmaceutical industry increasingly focuses on precision medicine, integrated biomarker strategies are becoming essential for therapy differentiation and streamlined regulatory approvals.

Challenges and Solutions in Biomarker Integration

While biomarker integration presents significant advantages, it also introduces operational complexities to development programs. Complex diseases often require the assessment of multiple biomarkers from limited samples, generating vast, multi-modal datasets across global sites. To address these challenges, pharmaceutical companies are turning to integrated testing services that offer sample-efficient workflows and comprehensive, customizable data outputs.

Labcorp, a leading provider of diagnostic solutions, has introduced a suite of broad biomarker profiling solutions to support efficient development approaches. These include:

• OmniSeq INSIGHT Genomic Profiling: This platform provides comprehensive solid tumor insights from limited samples, integrating DNA and RNA sequencing to reveal therapeutic targets, resistance markers, and trial eligibility.

• OmniSeq INSIGHT Whole Exome Sequencing (WES) and Whole Transcriptome Sequencing (WTS): These technologies enable the identification of actionable mutations and provide visibility into gene expression, offering a deeper understanding of tumor behavior and response mechanisms.

Streamlining Clinical Trials with Standardized Biomarker Testing

The integration of biomarkers and companion diagnostic (CDx) development into clinical trials is improving precision, outcomes, and timelines. However, these complex trials, especially those involving decentralized models, present logistical and compliance challenges.

To mitigate these issues, Labcorp has developed Labcorp Tissue Complete, a comprehensive genomic profiling (CGP) service powered by the FDA-cleared, CE-marked PGDx elio tissue complete kit. This service supports prospective clinical trials and CDx development, offering:

1. Regulatory confidence and trial efficiency
2. Measurable savings and ESG-aligned operations
3. Standardized workflows and optimized logistics across global locations

Additionally, Labcorp's CDx commercialization services provide dedicated study teams with expertise in diagnostic development and global compliance, seamless genomics infrastructure, and commercial strategies aligned to support market differentiation and reimbursement readiness.

As the pharmaceutical industry continues to advance precision medicine, navigating the path from biomarker discovery to diagnostic deployment requires coordination across scientific, operational, and regulatory domains. Integrated, purpose-built services that simplify logistics, enhance data quality, and accelerate CDx development are becoming increasingly crucial for pharmaceutical companies seeking to deliver faster insights, conduct smarter trials, and achieve stronger commercialization outcomes in the competitive oncology market.