Companion diagnostics promise to match patients with the most effective targeted therapies, but their translation into routine care remains uneven. Here, Jane Li, Senior Director Pharma CDx and CRO Partnerships at Thermo Fisher Scientific, discusses the scientific, operational, and reimbursement hurdles – and why pathologists are central to expanding access beyond academic medical centers.
Given that the science of biomarkers is so compelling, why is their clinical adoption so slow?
In my experience, biomarkers tend to lead precision medicine. But novel markers, especially predictive biomarkers, require extensive evidence generation. You have to demonstrate both analytical validity and clinical utility – often through large-scale validation studies or prospective clinical trials – to show that the biomarker truly informs treatment decisions. Because of that, adoption can take five to ten years, particularly for predictive biomarkers that guide therapy selection.
Once a biomarker is established, what challenges arise in bringing the associated testing technology into routine clinical use?
If you look at next-generation sequencing (NGS) 15 years ago, it was largely research-grade. Assays were developed in academic medical centers or single reference laboratories as laboratory-developed tests. They were run by highly skilled experts, using flexible protocols, with significant interpretive expertise and relatively limited regulatory oversight. That was an important first chapter of precision medicine.
But if you want precision medicine to reach patients in community or local hospital settings, the requirements are very different. The technology must be far more robust and standardized. You need locked-down operating procedures, automation, fully validated analytical performance, reproducibility, and usability by a broader, non-expert laboratory workforce.
Transitioning from research-grade to clinical-grade testing requires significant investment. In many cases, that means full in vitro diagnostic (IVD) development and navigating regulatory approval. That step alone can take years – and substantial resources.
Beyond assay development, what are the barriers to changing clinical practice?
Operationally, laboratories must integrate the assay into existing workflows – from specimen logistics to turnaround times. That can require infrastructure changes, new quality systems, and coordination across departments.
But the behavioral component is just as important. Pathologists, oncologists, and hospital administrators all need to understand the value of precision medicine and how it fits into the patient care pathway. That requires education, training, and alignment around clinical impact. Without that shared understanding, even well-validated diagnostics may be underutilized.
How does reimbursement play in to adoption of precision diagnostics?
Reimbursement is often the final and most significant barrier.
Coverage decisions require extensive clinical evidence – not just demonstration of clinical validity, but proof of economic value and cost-effectiveness. That typically means large-scale clinical and health economic studies.
Importantly, reimbursement also requires alignment across multiple stakeholders: payers, pharmaceutical companies, medical societies, regulators, and providers. Achieving that alignment can take years.
When adoption of biomarker testing lags, how does it affect the patients?
When adoption of a companion diagnostic is limited, the consequences are very real. Eligible patients may not be tested, which means targeted therapies cannot be administered. Instead, those patients may receive standard treatments that are less effective for their specific disease biology. So there is a direct impact at the patient outcome level.
How does biomarker testing adoption differ between academic medical centers and community hospitals?
Academic centers have largely led the way in precision medicine. NGS testing is often performed in-house, integrated into clinical pathways, and routinely discussed in multidisciplinary tumor boards. In those environments, comprehensive biomarker profiling is standard practice.
In community hospital settings, however, adoption has historically been more limited. The complexity of NGS – from technical performance to bioinformatics and interpretation – has made it challenging for many local hospitals to bring testing in-house.
Some institutions send samples to reference laboratories, but that can mean turnaround times of several weeks, potentially delaying treatment decisions. Others may not test comprehensively at all. In those cases, patients may be started on an immunotherapy–chemotherapy combination in the frontline setting without broad molecular profiling. That represents a missed opportunity to evaluate the full range of targeted therapeutic options.
This inequity extends beyond the US. In Europe and the US, precision oncology infrastructure is relatively advanced. But in many lower income countries, there may be limited access to skilled personnel, bioinformatics support, and advanced testing platforms. Access to targeted therapies is also more constrained.
So, the challenge is not only scientific – it is structural. We have to ensure that both testing and therapy are accessible across care settings and across regions. Otherwise, innovation risks widening disparities rather than reducing them.
How should diagnostics companies rethink their role in precision medicine?
Diagnostics companies need to shift from being technology providers to being clinical solution providers.
Broader access to precision medicine depends on enabling workflows that are practical and sustainable in community hospital laboratories. That means the technology must evolve – not just in performance, but in usability.
In many cases, that requires fully automated, end-to-end solutions that can be implemented by non-expert users. An FDA-approved IVD platform or companion diagnostic can help significantly. It reduces the validation burden and shortens time to implementation. It also increases confidence in performance and interpretation.
With NGS panels that generate hundreds or even thousands of variants, interpretation is often one of the most challenging aspects. An approved product helps simplify reporting and provides greater assurance that the laboratory is delivering clinically reliable results to physicians.
The second piece is around turnaround time. It’s no longer enough for a diagnostic solution to be accurate and easy to use. It must also deliver results within the therapeutic decision window. Rapid turnaround is essential to ensure that biomarker information meaningfully informs frontline treatment selection.
How are real-world specimen constraints shaping diagnostic development in oncology?
As a diagnostics company, we always say that we have to develop products for real-world samples.
In oncology, tissue samples are getting smaller. We’re increasingly working with fine-needle aspiration samples or core needle biopsies, where material is limited. For patients with relapsed disease, rebiopsy is often not feasible. So in the real world, adequate tissue is not always available.
That reality forces diagnostic companies to rethink how technologies are developed. Assays must be tissue-sparing and capable of delivering reliable results from very small inputs. In parallel, there is growing emphasis on platforms that can work with alternative sample types, such as plasma and urine, particularly when tissue biopsy is not possible.
What role do pharma–diagnostic partnerships play in accelerating adoption?
When a drug and its companion diagnostic are developed and launched together, it can streamline education, align clinical evidence generation, and support more favorable reimbursement discussions. A coordinated launch also helps physicians understand how the test fits into the therapeutic pathway.
In that sense, co-development is not only about regulatory alignment – it’s also about accelerating clinical adoption. When the drug and diagnostic are introduced as part of a unified clinical strategy, it becomes easier for laboratories and clinicians to integrate both into practice.
What's more, when a companion diagnostic is launched at the same time as its associated therapy, the biomarker clinical utility is already proven with the drug's regulatory approval. That can lead to more favorable reimbursement coverage. Here, the pharma–diagnostic partnership really comes into play, because reimbursement is the key to any clinical adoption.
Can decentralized testing help?
Historically many of the pharma–diagnostic partnerships have relied on single-site commercial labs for a centralized testing model. While this model is successful in the US, it is very difficult to scale internationally.
Distributed companion diagnostic platforms offer flexibility within regulatory approval pathways and reimbursement frameworks in other countries and regions. Ultimately, we want companion diagnostic tests to be implemented in any country, within its local laboratory capability and training needs.
What role do pathologists play in advancing precision medicine?
Historically, we’ve talked about tissue stewardship as a core responsibility in pathology. But in this era of expanding biomarker testing, that responsibility has become more complex – and more critical.
Twenty years ago, cancer testing largely meant immunohistochemistry for protein biomarkers, or perhaps a single-gene PCR or FISH assay. Over the past decade, that has evolved into long lists of molecular biomarkers assessed by NGS, along with complex genomic signatures such as MSI-H/dMMR, HRD, or TMB. Looking ahead, we’re seeing the emergence of multi-omics approaches that will further expand testing demands.
So the testing menu is expanding, but the tissue is not. This makes tissue stewardship more strategic than ever.
How should pathologists approach tissue stewardship in this increasingly complex testing landscape?
Pathologists should be selecting testing platforms that are tissue-sparing, highly sensitive, and capable of multiplexing multiple biomarkers in a single assay. It also means considering technologies that can be validated for alternative sample types, such as plasma or urine, when tissue is insufficient.
The demand on a single specimen continues to grow. Pathologists are uniquely positioned to balance comprehensive testing with responsible tissue utilization, ensuring that the patient derives the greatest possible benefit from a limited sample.
Beyond tissue stewardship, how do pathologists influence operational performance and clinical decision-making?
Precision medicine is inherently multidisciplinary. Treatment decisions are often made in tumor boards that include oncologists, pathologists, surgeons, and other specialists. In that setting, pathologists have a significant opportunity to lead – by educating colleagues about biomarker relevance, guiding optimal testing strategies, and helping interpret complex genomic results.
Oncologists may understandably want to “test everything.” But with limited tissue and expanding options, thoughtful prioritization is critical. Pathologists can serve as trusted advisors, helping optimize testing strategies so that clinical decision-making is both comprehensive and practical for each patient.
What advice would you offer to pathologists on implementing companion diagnostic tests?
Our direct customers are pathologists. We understand their workflows, their validation requirements, and how to support implementation. But what we’ve learned is that delivering rapid NGS to patients often depends just as much on oncologists.
Oncologists are the ones ordering the tests. They play a critical role in determining whether comprehensive molecular profiling happens – and when.
Interestingly, when I attend oncology conferences, I often find that many oncologists are not aware that NGS can now be delivered with very rapid turnaround times, or that it can be implemented close to the patient in local hospital settings. There is still a perception that NGS is complex, centralized, and slow.
How can the laboratory community help close that knowledge gap?
Pathologists are already trusted advisors within multidisciplinary teams. They are well positioned to educate oncology colleagues about advances in testing – particularly around turnaround time, decentralization, and implementation in community settings.
At the same time, diagnostics companies need to engage more directly with oncologists, whether through conferences, educational initiatives, or collaborative programs. If oncologists continue to assume that NGS is slow or inaccessible, they may default to empiric treatment decisions rather than waiting for comprehensive profiling.
Ultimately, if we want rapid NGS to influence frontline therapy decisions, both the laboratory and the oncology community need to be aligned. Awareness is just as important as technology.
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