Biomarker testing is foundational to successful targeted and immunotherapy development. From discovery to commercialization, strategic biomarker integration accelerates research and development, improves patient stratification and reduces trial risk. Robust biomarker strategies can enhance therapy differentiation while streamlining regulatory approval processes and improving ROI in a competitive, precision-driven environment.

Managing data complexity and minimizing operational risks

Even with its advantages, biomarker integration can prove challenging. Namely, implementing and scaling biomarker testing introduces operational complexity to development programs. Complex diseases demand assessment of multiple biomarkers from often limited samples, generating vast, multi-modal datasets that may be produced across global sites. Because harmonizing this data is resource-intensive and time-sensitive, trial delays and compromised insights become more likely without standardized workflows.

Strategic solutions for exploratory and observational research: Sample-sparing, insight-rich platforms

To address these challenges, recognizing the value of biomarker testing in exploratory and observational studies is paramount. During research stages, biomarkers can illuminate mechanisms of action, provide safety and efficacy data and identify potentially responsive patients, helping reduce the risk of harm and streamlining trials. Retrospective testing can reveal predictive and prognostic markers and inform future study design.

Notably, samples may be limited in number, quantity or quality, requiring thoughtful stewardship. An integrated testing service with sample-efficient workflows and comprehensive, customizable data outputs can maximize biological insights with minimal waste. To support this efficient approach to development, Labcorp offers the following suite of broad biomarker profiling solutions.

These platforms accelerate critical early decisions, preserve biospecimen integrity and deliver actionable insights that shape smarter therapeutic strategies.

Streamlining complex clinical trials: Standardization with operational and environmental ROI

Integrating biomarkers and companion diagnostic (CDx) development into clinical trials can increase precision, improve outcomes and accelerate timelines. These tools help guide study design, patient selection, treatment evaluation and more. Additionally, biomarker and CDx tests can demonstrate a clear link between biomarker status and treatment benefit, strengthening evidence for regulatory approvals.

Mitigating the logistical and compliance challenges introduced by such complex clinical trials—especially those involving decentralized models—hinges on streamlined, scalable solutions and deep experience. Sponsors need laboratory partners who can deliver speed, accuracy and commercial readiness with sustainability, which is why Labcorp offers key solutions such as globally available tissue profiling designed to accelerate the development of impactful diagnostics.

Labcorp Tissue Complete: A comprehensive genomic profiling (CGP) service powered by the FDA-cleared, CE-marked PGDx elio tissue complete kit to support prospective clinical trials and CDx development. Decision-makers benefit from regulatory confidence and trial efficiency as well as measurable savings and ESG-aligned operations.

• Leveraging an FDA-cleared test facilitates a pathway for regulatory approval
• Available in Labcorp Baltimore (U.S.), Geneva (CH) and Shanghai (CN) labs offering support for decentralized trials
• Standardized workflows and optimized logistics across locations ensure data quality and reduce delays and risks, while aligning with sustainability goals to reduce carbon footprint

CDx commercialization services: Purpose-built for compliance and delivery

Bringing a CDx to market demands precise regulatory planning and operational execution. Our integrated model simplifies stakeholder engagement and supports synchronized diagnostic–therapeutic launches:

• Dedicated study teams with hands-on expertise in diagnostic development and global compliance
• Seamless genomics infrastructure in strategic Labcorp locations ensures scalability and rapid deployment
• Commercial strategies aligned to support market differentiation and reimbursement readiness

As precision medicine continues to drive advances in healthcare, navigating the path from biomarker discovery to diagnostic deployment requires coordination across scientific, operational and regulatory domains.

Advance your program with confidence through integrated, purpose-built services that simplify logistics, enhance data quality and accelerate CDx development. From tissue management to global compliance, Labcorp’s solutions deliver faster insights, smarter trials and stronger commercialization.