Immuno-oncology examines how the immune system influences cancer development and treatment.1 However, to develop successful treatments, it is essential to have a deeper understanding of the interaction between tumors and the immune system. Biomarker assessment strategies are critical in this regard, as they help unlock the complexities of tumor-immune dynamics and guide more informed treatment decisions.
Combining flow cytometry (FCM), immunohistochemistry (IHC), and next-generation sequencing (NGS) allows researchers to perform advanced biomarker assessments. This integrated approach provides a more comprehensive view of immune responses within the tumor microenvironment and supports a more accurate prediction of how patients may respond to treatment. But generating high-quality data is only one part of the challenge. Turning those insights into successful clinical outcomes also depends on operational expertise and reliable support.
Clinical research teams need partners who can ensure trial success and accelerate time-to-market, which is why HBRI stands out as a trusted partner in facilitating immuno-oncology success. This article will explore three key elements of biomarker strategy and operational excellence—spanning scientific integration, operational expertise, and global capability—that collectively support more efficient, reliable, and insight-driven clinical trials.
- Combined Biomarker Strategies
The immune system’s interaction with cancer is highly dynamic. As a result, immuno-oncology trials increasingly depend on integrated biomarker strategies that unite multiple analytical techniques to capture the full complexity of the tumor and its changing immune microenvironment.
No single technique is sufficient on its own. Instead, researchers integrate FCM, IHC and NGS techniques together to generate a more holistic understanding of the immune landscape.2 This enables researchers to obtain a complete picture into biomarker assessment, allowing refined patient stratification, robust immune response monitoring and better prediction of treatment outcomes.
Flow cytometry (FCM) rapidly profiles a patient’s immune system by analyzing both surface and intracellular markers, enabling functional immune analysis and precise immunophenotyping. It delivers detailed multidimensional insights that help guide immuno-oncology treatment decisions, while standardized protocols ensure reliable and reproducible results across studies.
Immunohistochemistry (IHC) is a cost-effective antibody-mediated screening tool that can profile tissue samples and provide both biomarker detection (e.g. PD-L1), immune cell localization, and structural information about the tumor and its microenvironment. Advanced multiplex IHC allows several biomarkers on a single tissue section, maximizing insight from limited samples, which guides patient selection and supports immuno-oncology treatment decisions.
Next-generation sequencing (NGS) is a technology that offers high-throughput, ultra-fast measurement of nucleic acids. It can sequence millions of DNA fragments simultaneously from the entire genome or targeted regions, thus revealing the underlying genetic and molecular information that drive immune activity and resistance.3
NGS used in oncology trials allows for comprehensive profiling of solid and hematologic tumors, helping researchers uncover DNA mismatch repair deficiency (dMMR), tumor mutational burden (TMB) and microsatellite instability (MSI), which are key indicators of how a patient may respond to casein kinase 1 (CK1). Additionally, NGS provides in-depth analysis of the patient’s immune repertoire by analyzing T-cell and B-cell receptors (TCR and BCR).
No single platform can fully capture the complexity of the immune response. FCM reveals immune cell behavior, IHC shows their distribution within the tissue and NGS uncovers the molecular response to treatment and identifies gene alterations. Together, these platforms enable researchers to correlate cellular activity, spatial context, and genomic alterations, creating a more complete picture of the immune response over time.4
This integrated approach allows for more reliable predictions of efficacy and safety, which increases the likelihood of clinical success and supports more personalized, biomarker-driven protocols.
- Operational Excellence
Operational excellence is just as important as technology to ensure successful trials.
Global lab harmonization, robust biobanking, custom assay development and strong project management are vital to maximize efficiency and data integrity in modern immuno-oncology trials, which enable consistent data and reproducible results.
- Selecting the Right Partner
Selecting the right central laboratory partner is essential for accelerating study timelines and supporting the transition from translational research to commercialization. An effective partner will understand the value of a holistic approach—combining techniques like FCM, IHC, and NGS to gain deeper insights into immune activity and deliver real-time data on the tumor and its evolving immune microenvironment throughout treatment.
Ultimately, this strategy of coupling technologies and integrating operational excellence drives the future of immuno-oncology, and using a partner such as HBRI, which understands this, can reduce development risks and accelerate the delivery of life-changing immunotherapies to patients worldwide.
Why Choose HBRI as a Partner?
HBRI brings over 35 years of experience and extensive expertise in integrating FCM, IHC, and NGS into comprehensive, fit-for-purpose biomarker strategies that support faster, more informed clinical decision-making.
Our laboratories host one of the industry’s largest assay portfolios, covering more than 250 validated IHC biomarkers, multiple PD-L1 clones, expansive multiplex panels, and advanced NGS assays for solid tumors and hematological malignancies, which ultimately help sponsors move efficiently from discovery through to commercialization.
HBRI’s global laboratory network enables harmonized operation across five continents, ensuring data from different trial sites are standardized and comparable. This translates to faster startup times, validated results, and greater confidence in regulatory submissions.5
Our clients have direct access to Ph.D. and M.Sc.-level scientific experts who provide early input on protocol design, biomarker selection, and customized strategies for protocol optimization. This collaboration helps translate research goals into validated, fit-for-purpose workflows, resulting in faster turnaround times and more efficient study execution.
HBRI also delivers sophisticated project management and a unified global study database for real-time transparency and efficiency in complex late-stage multinational trials. While we typically require eight weeks for study startups, timelines can be expedited based on the customer’s specific needs. In one case study, our team was able to make a phase III trial operational in less than two weeks, demonstrating how operational excellence directly accelerates development timelines.
HBRI combines high-throughput sequencing capacity—capable of processing up —with access to biobanking resources that maximize the value of each patient sample. These patient-centric multiplex capabilities enable sponsors to accelerate discovery, optimize tissue use, reduce patient burden, and enhance the probability of regulatory approval.
Implications for Immuno- oncology
HBRI draws from 35 years’ experience to combine global reach, scientific expertise and cutting-edge technologies like FCM, IHC, and NGS to deliver integrated biomarker success. By aligning scientific innovation with operational excellence, we help sponsors navigate the complexity of Immuno- oncology and move with clarity from discovery to commercialization, bringing promising therapies to patients faster.
