The Precision Oncology Divide 

The ability to identify genomic variants has powered precision oncology, allowing clinicians to connect specific mutations to targeted therapies quickly enough to influence treatment decisions. Technologies such as CGP function as key companion diagnostic assays, sequencing hundreds of cancer-related genes and enabling more precise treatment choices for each patient. Although precision oncology has delivered substantial benefits for many cancer types, some cancers, particularly rarer ones, have seen far less impact from these approaches.

A systematic review of 14 CGP studies involving 35,975 patients showed that CGP-guided treatment improved overall survival and progression-free survival across cancer types, but patients with rare cancers were less likely to receive a genomically matched therapy than those with more common cancers¹. A separate study found stark differences across cancer types in how often CGP results led to an approved or experimental biomarker-linked therapy. Lung cancer, the most commonly diagnosed cancer worldwide, saw roughly 20% of patients receive matched treatment, compared to just 2% for pancreatic cancer, the 11^th most common². While pancreatic cancer is not classified as a rare cancer, this finding highlights a gap in therapeutic benefit between cancer types and underscores how the limited maturity of targeted therapies for pancreatic tumors remains a barrier to more personalized care.

Why Rare Cancers Fall Further Behind

Despite this documented benefit, only around 8% of patients currently receive CGP‑guided biomarker-linked therapy, indicating that broader CGP access is needed not only to narrow the rare cancer treatment gap but also to improve outcomes across cancer types more generally. A systematic review of 14 CGP studies found that 40-94% of patients had at least one clinically actionable alteration identified by CGP¹, highlighting that barriers beyond test access, such as therapy availability, interpretation, and workflow, also drive the disconnect between genomic insights and real-world treatment.

Increased CGP testing alone is not enough to close the gap between genomic results and real-world treatment. Most CGP reports do not explicitly rank or prioritize which targetable mutations have the strongest clinical evidence. In the absence of standardized frameworks, different clinicians may interpret the same findings differently, meaning some patients may never be offered a potentially effective targeted therapy. Compounding this, there is still no uniform guidance on which tumor types should routinely receive CGP, so decisions about whether to test are often left to individual clinical teams, introducing further inconsistency. When CGP is performed, clinicians must often manually judge which alterations are truly actionable, adding workload to already stretched teams and increasing the risk that a clinically meaningful, possibly life‑changing mutation is missed simply due to limited time and resources.

Closing the Gap

Closing the rare cancer treatment gap will require more than simply ordering CGP more often. It will require changes in how results are interpreted, acted on, and shared across systems.

Molecular Tumor Boards

A minority of CGP studies make use of the insights of a molecular tumor board (MTB), a multidisciplinary panel of oncologists, geneticists, pathologists, and pharmacologists who convene to review a patient’s genomic profile and collectively recommend the most clinically appropriate, evidence-supported treatment option. Importantly, in studies where MTB review was used, patients consistently had better outcomes than when treatment decisions were made independently by individual physicians, underscoring that expert, structured interpretation may be just as critical to closing the treatment gap as access to the test itself¹.

Tumor Agnostic Biomarkers

A promising way to narrow this gap is to focus on tumor‑agnostic biomarkers that can be directly linked to specific treatments, regardless of where the cancer originates. Examples include global tumor mutational burden and microsatellite instability status, both already used to guide pan‑tumor immunotherapy approvals². By anchoring decisions to these molecular features rather than anatomical sites, CGP‑derived biomarkers can extend targeted options to patients with rare cancers, helping them access therapies even when tumor‑specific approvals for their cancer type do not yet exist.

Liquid Biopsies and Additional Analyses

Another promising way to expand CGP’s value in rare cancers is through more accessible biomarkers. Liquid biopsies can capture circulating tumor cells and circulating tumor DNA, enabling CGP when tissue is scarce or difficult to obtain. Combining CGP with additional analyses can also increase the yield of actionable findings from tumor samples. For instance, integrating transcriptomic profiling links genomic mutations to gene expression patterns and provides richer biological context, making it easier to translate genomic insights into concrete treatment decisions.

Global Data-Sharing and Harmonized Knowledgebases

Today, variant interpretation is spread across multiple, partially overlapping databases, so clinicians have no single, unified reference for assessing genomic findings. Mutations from rare cancers are less likely to be comprehensively represented in all of these resources, increasing the risk that a clinician using one database may miss a potential targeted option that appears in another. Aggregating CGP results into harmonized, shared knowledgebases would enable more powerful analyses and help reveal cross‑tumor patterns in rarer cancers, improving variant interpretation and supporting more informed, evidence‑based treatment decisions.

Conclusion

Broader CGP access is a critical step toward closing the rare cancer treatment gap, but it is not the whole story. As more patients are tested, CGP will continue to uncover a high proportion of clinically actionable alterations, with systematic data suggesting rates as high as 94%. However, only a small minority currently receive genomically matched therapy. Without parallel investment in downstream interpretation and treatment pathways, including molecular tumor boards, standardized evidence‑tiering for variants, and more reliable access to matched drugs and trials, expanded testing will mostly increase the number of unrealized opportunities rather than consistently translating findings into better outcomes. Access to robust CGP analyses, particularly those integrating genomic alterations with transcriptome data, will expand the pool of clinically relevant biomarkers and increase the likelihood that patients with rare cancers can be matched to effective therapies and trials.

Reach out to Sampled’s experts to learn more about CGP and how it can be combined with additional omic layers in our CLIA‑licensed, CAP‑accredited fully integrated analytical laboratory and biorepository.

References

1. Limaye S, Deshmukh J, Rohatagi N, et al. Usefulness of Comprehensive Genomic Profiling in Clinical Decision-Making in Oncology: A Systematic Review. J Immunother Precis Oncol. 2025;8(1):55-63. doi:10.36401/JIPO-24-11 

2. Saito Y, Horie S, Kogure Y, et al. Real-world clinical utility of comprehensive genomic profiling in advanced solid tumors. Nat Med. 2026;32(2):690-701. doi:10.1038/s41591-025-04086-8 

Piscataway, NJ – Sampled, an integrated analytical laboratory and biorepository, has partnered with 10x Genomics to offer a Spatial In Situ Gene Expression Services Grant, using the Xenium Prime 5K assay, for researchers across the United States.

Spatial transcriptomics is a rapidly growing field that allows scientists to map gene expression across different conditions within a tissue’s natural architecture. This approach has important applications in both physiological and disease research, including studies of tumor microenvironments and neurodegenerative tissues, by revealing cellular activation states, developmental trajectories, and cell identities.

In support of bold research aimed at advancing our understanding of health and disease, Sampled is excited to announce a new grant opportunity: one researcher will be awarded a complete 10x Genomics Xenium Prime 5K assay workflow for four slides, worth $46,000, performed end-to-end by our technical experts. The awardee may submit fresh-frozen or FFPE tissue and will receive a comprehensive dataset covering cell boundaries, transcript locations, gene expression profiles, and the spatial organization of cells and transcripts.

The 10x Genomics Xenium platform is a best-in-class technology for spatial gene expression mapping. A single slide using the Xenium Prime 5K panel provides expression analysis of approximately 5,000 genes across intact tissue containing an imageable area of 236mm². Insights gained from the Xenium can provide a powerful starting point or complementary dataset for diverse research programs spanning discovery through to translational work. The Xenium helps to answer research questions centered on complex cellular interactions, such as tracking the evolution of cancer tissue and assessing immune cell dynamics post-treatment.

Sampled supports state-of-the-art research as a Certified Service Provider for 10x Genomics Xenium In Situ, Visium Spatial, and Chromium Single Cell platforms. As a leader in cellular and molecular biology platforms, 10x Genomics enables researchers to generate high-resolution insights into gene expression, cellular identity, and tissue architecture, powering the next generation of discoveries.

In addition to delivering end-to-end workflows using 10x Genomics platforms, Sampled’s integrated services span sample collection, storage, processing, and bioinformatics analysis. By applying expertise at every step, we help protect sample integrity and generate robust, reliable data to support research and downstream decision-making.

About Sampled

Sampled is a fully integrated laboratory and biorepository service provider delivering solutions for collecting, analyzing, and storing biological samples. Founded in 1999 as RUCDR at Rutgers University, Sampled provides state-of-the-art biobanking, multiomics, cell services, and custom clinical kitting solutions. Sampled’s CAP-accredited and CLIA-licensed operations support high-quality sample storage, management, and analysis, empowering life science organizations to speed time to reliable data, enable new discoveries, and advance human health. 

Media Contact

Caroline Mitchell, PhD

Director, Content & Creative Strategy, Sampled

communications@sampled.com

As the world’s only Global Integrated Analytical Biorepository, Sampled are uniquely positioned to ensure sample integrity by minimizing risk to samples. Clients no longer need to risk the integrity of their samples or becoming compromised due to repeated shipment between multiple sites for analysis at third party labs before being sent back into storage. Instead, their samples are stored in the same facility as the one they are analyzed in, ensuring that they are subjected to the same SOPs, storage conditions and limited amount of handling.

Here is how Sampled can aid oncology researchers in the first three key stages of their research by utilizing the Global Integrated Analytical Biorepository.

1. Research and Discovery Stage

Groundbreaking discoveries in oncology all start with the research and discovery stage, where researchers explore potential biomarkers, therapeutic targets, and disease mechanisms in order to exploit them. Outsourcing key services to Sampled can accelerate this stage by:

• Efficient storage and retrieval.

Example: A dedicated sample storage service ensures the preservation of valuable biological specimens. By outsourcing cryogenic storage to our specialized facility with CAP/CLIA accreditation researchers have access to well-preserved samples that are cared for round the clock by a dedicated team of experts working to ISBER best practices.

• Access to High-throughput analysis

Utilizing outsourcing services for transcriptome analysis using microarrays or next generation sequencing enables researchers to examine gene expression at a large scale. This can uncover potential biomarkers and pathways associated with specific cancers, providing a wealth of data for further investigation.

• Gaining comprehensive genomics insights

Outsourcing next-generation sequencing (NGS) allows researchers to delve deep into the genomic landscape of cancers. This can unveil genetic mutations, the epigenetic landscape and potential therapeutic targets that may guide subsequent stages of research.

2. Preclinical Research Stage

After promising leads have been identified, the preclinical research stage aims to validate and optimize potential therapies before moving to clinical trials. Outsourcing services during this stage provides several advantages:

• Cryogenic Storage

Outsourcing cryogenic storage ensures that preclinical samples, including cell lines and animal tissues, are securely stored in facilities equipped with backup power, up-to-date SOPs and trained staff. Our centralized Global Integrated Analytical Biorepository facility minimizes the risk of sample degradation and ensures uniform handling as well as correct documentation and recording for request by governing bodies such as the FDA etc.

• Comparative analysis

Outsourcing next generation sequencing services for comparative genomic and transcriptomic analysis between normal and cancerous tissues helps identify potentially important variations associated with tumor development. This aids in validating potential targets and stratifying patient populations for future clinical trials. Similarly, Sampled can provide access to cutting edge single cell and spatial RNA sequencing platforms to provide a global view of gene expression patterns, aiding in the identification of potential biomarkers at high resolution as well as therapeutic targets.

• Targeted sequencing for validation

Targeted sequencing allows researchers to validate candidate genes identified in the discovery stage efficiently. This stage may involve screening a larger number of samples to confirm the relevance of genomic alterations and assess their potential as therapeutic targets. Sampled can scale our services to meet your needs allowing you to be agile and able to meet shifting deadlines.

3. Clinical Trial Phase

Moving into the clinical trial phases requires meticulous planning, adherence to regulatory standards, and precise execution. Outsourcing critical services can streamline this process and ensure that your research meets the expectations of regulatory bodies.

• CAP/CLIA accredited sample storage

Sampled offers sample storage services that either meet or exceed the industry standards as set out by the College of American Pathologists (CAP) and Clinical Laboratory Improvement Amendments (CLIA). This ensures compliance with regulatory requirements for clinical trials since our facilities are equipped with scalable storage solutions which can accommodate the increased volume of patient samples while maintaining the necessary levels of quality control.

• Biomarker identification and patient stratification

Utilizing outsourcing services for transcriptome analysis in clinical trials allows for the identification of predictive biomarkers. This information is crucial for stratifying patient populations, optimizing treatment strategies, and improving the overall success rate of the trial.

• Real-time genomic monitoring

Outsourcing real-time sequencing services during clinical trials enables researchers to monitor genomic, epigenetic and transcriptomic changes in patients over the course of the study. This dynamic approach allows for adaptive trial design, optimizing treatment protocols based on evolving insights.

4. Regulatory Review and Approval

The difference between a drug/therapy gaining regulatory approval or being delayed can lie in the details that are involved in the meticulous review process. Here, regulatory bodies such as the FDA require access to a wide range of data from cryostorage temperature logs for samples that were transported between sites to genomic data. If your data is unreliable, inaccurate or does not comply with their rules and regulatory standards it could spell disaster and delay the product’s release.

• Ensuring compliant sample preservation

Outsourcing cryogenic storage to our Global Integrated Analytical Biorepository, ensures samples are stored under regulatory-compliant conditions, facilitating smooth regulatory review processes. This is because our team of experts are trained to follow the latest SOPs that conform to processes laid out by regulatory bodies such as the FDA. Not only will your sample’s integrity be preserved for years to come, but they will also meet the requirements laid out by major regulatory bodies should they be recalled from storage for review.

• Regulatory Compliance Support

Sampled has a proven track record of working with large and smaller biopharmas for  many years and has aided researchers in meeting regulatory requirements for many studies including those based in oncology.

• Generation of high-quality data for regulatory submissions

By outsourcing sequencing requirements to Sampled, researchers can ensure that the genomic data generated for regulatory submissions is accurate, reliable, and complies with regulatory standards.

5. Manufacturing and Scaling Up

• High-throughput analysis for large-scale studies

Outsourcing microarray services to Sampled allows researchers to scale up gene expression profiling efficiently, a critical step in understanding the molecular intricacies of oncology. We have the resources to scale to meet your needs, which removes any need for you to find capital expenditure to purchase new platforms, hire new staff and maintain projects. This means you can focus on the research that matters most and let us do the heavy lifting on your behalf.

• ICH Stability Storage

Sampled are specialists when it comes to providing stability storage services. Our experts have worked in stability storage many years and adhere to ICH guidelines, providing reliable data on the stability of drug candidates and packaging during the manufacturing and scaling-up stages.

• Comprehensive management of sample logistics

Utilizing our lifecycle management services streamlines the handling and tracking of samples, ensuring integrity and compliance throughout the manufacturing process. We have a bespoke kitting and logistics service that is tailored to your needs including those clients who need logistical support that is compliant with regulatory bodies for clinical trials.

6. Post-Market Surveillance

• Data analysis for continuous surveillance

Outsourcing bioinformatics services to Sampled enables researchers to handle vast datasets generated during post-market surveillance efficiently. This aids in identifying trends, potential safety concerns, and optimizing treatment strategies.

• Outsourcing specialized cell-based assays

Sampled also provides cell services including iPSC cell line generation, PBMC isolation and CRISPR gene editing services allowing researchers to conduct in-depth studies on cell behavior during post-market surveillance, contributing valuable insights for ongoing safety assessments.

• Monitoring genomic changes over time

We offer researchers the ability to continue sequencing their samples during post-market surveillance to ensure ongoing monitoring of genomic variations and potential resistance mechanisms, aiding in adapting treatment approaches as needed. The benefits of this are that it provides reliability and accuracy to the data generated as the same platforms, SOPs, methods of investigation have been used to sequence the samples before, during and after the drug has gone to market.

Conlusion: Outsourcing Oncology Research Services to the Global Integrated Analytical Biorepository

In summary, outsourcing services to Sampled offers a myriad of advantages throughout the research pipeline, from the initial stages of discovery to the critical stages of clinical trials. By leveraging specialized expertise and cutting-edge technologies within our Global Integrated Analytical Biorepository, researchers can enhance the efficiency, accuracy, and success of their endeavors, ultimately contributing to the advancement of cancer diagnostics and therapeutics.

To learn more about how our scientists can accelerate your research click here