Precision medicine is often viewed through the lens of what is new: novel biomarkers, improved assays and increasingly targeted therapies. The science is moving quickly, and in many disease areas, new findings are creating new treatment options as they move from the research bench into the clinic.
However, the value of that progress depends on whether it can be delivered reliably in routine practice. A diagnostic may be validated and available, yet still fail to influence care because it is not ordered consistently, processed efficiently, or returned in time to support a treatment decision. In many cases, implementation remains the main obstacle.
For precision medicine to extend beyond leading academic centers, the industry must pay closer attention to how diagnostics become part of routine care and how they can be delivered consistently across different healthcare settings.
When companion diagnostics lag, patients pay the price
Diagnostic innovation covers a broad range of technologies and clinical applications. For new biomarkers, widespread adoption depends on evidence of clinical validity and utility. Building that evidence may require large validation studies, prospective trials, multicenter cohorts, and regulatory approvals linked to specific claims. For predictive biomarkers in particular, it can take five to ten years before they’re widely used in practice. Most of that time is spent building confidence in the signal, standardizing interpretation, and linking results to decisions that meaningfully change outcomes.
Companion diagnostics (CDx) sit at the intersection of pathology, drug development, and patient access. They identify patients who are most likely to benefit from a targeted therapy, so slow adoption can have immediate consequences. Eligible patients may not be tested and therefore may not be offered the most appropriate treatment. Others may receive a less effective standard therapy, while delays in oncology testing can postpone decisions at a point when time is particularly important.
Testing gaps can also persist after guidelines and reimbursement pathways are established. One large claims-based cohort study found that biomarker testing remained suboptimal among patients with advanced cancer despite guideline recommendations and broader insurance coverage.
The access gap beyond academic centers
One of the clearest implementation challenges is the difference between academic medical centers and decentralized care settings. Community hospitals treat an estimated 80–85 percent of cancer patients in the US, so barriers outside academic centers affect access on a large scale.
In many academic centers, next-generation sequencing (NGS) testing is available in-house and integrated into clinical pathways. Community settings often face a different reality: limited in-house expertise for complex NGS systems, reliance on send-outs to reference labs and longer TAT. Some sites, in practice, may not test at all.
Turnaround time can determine whether a diagnostic result influences treatment. In routine practice, comprehensive genomic profiling may take weeks when samples are sent out, when tissue is limited, or when workflows require sequential testing. Regardless of the specific number, the practical implication is the same: when results arrive after a treatment decision is already made, patients may miss the opportunity to benefit from matched therapy.
If precision medicine remains concentrated in academic centers, inequities in access will persist. Closing that gap requires implementation models that work in regional and community settings, including testing strategies built for real-world specimens and workflows.
Specimen realities shape CDx scalability
Scaling CDx and NGS depends on decisions made upstream, before a sample is ever sequenced, including how tissue is collected, handled and allocated across competing testing needs.
As biomarker testing expands from familiar IHC markers to complex genomic signatures and emerging multi-omic approaches, tissue stewardship becomes higher stakes. There may be limited material, multiple tests competing for the same specimen and a narrow window to deliver results that can still change a plan.
CDx strategies that account for these constraints from the beginning tend to be easier to implement at scale. They also support stronger evidence generation and smoother launch readiness by reducing variability across sites and settings.
From diagnostic technology to clinical delivery
Diagnostics companies must consider how instruments and assays will function within real care pathways. Advanced testing has limited value if it cannot be incorporated into routine workflows.
Community hospitals need systems that are straightforward to operate and capable of producing consistent results where specialist expertise may be limited. Automation and standardized processes can help, while an FDA-approved in vitro diagnostic platform may reduce the local validation burden and support reimbursement discussions.
Turnaround time should also be treated as an important measure of test performance. As treatment options expand across targeted therapies, immuno-oncology, and antibody-drug conjugates, clinicians often need results early enough to inform first-line treatment.
Tests must also be designed around the specimens available in routine care. Tissue may be scarce, and repeat biopsy is not always possible. Tissue-conserving methods, multiplexing, high analytical sensitivity, and validated alternatives such as plasma or urine can therefore widen access when tissue is insufficient.
Early collaboration between pharmaceutical and diagnostics companies can improve CDx co-development. Aligning biomarker strategy, clinical trials, regulatory submissions, and launch planning can allow the drug and diagnostic to reach the market together. This gives clinicians clear testing requirements from launch and can support reimbursement and adoption.
Global implementation requires additional planning. Centralized testing models may work in the US but prove difficult to reproduce elsewhere. Wider access may depend on distributed platforms that align with local regulations, reimbursement systems, laboratory capacity, and training requirements.
Making precision medicine deliverable at scale
Precision medicine will continue to advance. The more urgent question is whether the ecosystem can make proven diagnostics consistently available in the settings where most patients are treated, and quickly enough to influence treatment decisions.
Meeting that standard requires deliberate choices upstream: aligning biomarker strategies to clinically feasible workflows, designing CDx programs with the end-to-end testing pathway in mind and partnering early so evidence generation, regulatory strategy and access planning move together. Discovery is powerful, but delivery is decisive.
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