From Biomarkers to Real-world Impact

Transition from Established Diagnostics to Broader Molecular Profiling

Currently, oncology diagnostics include a range of diagnostic technologies, from histopathology, immunohistochemistry (IHC) and single-gene assays to fluorescence in-situ hybridization (FISH), polymerase chain reaction (PCR), and broader genomic profiling. The evolution from testing individual biomarkers toward broader molecular profiling is transforming oncology decision-making.

This broader profiling is particularly significant for Companion Diagnostics (CDx). A multigene panel (e.g., Next-generation Sequencing (NGS))¹ is not automatically a companion diagnostic; rather, a test or specific component of a test becomes a companion diagnostic when it is authorized for use to support the identification of patients whose tumors carry alterations relevant to specific therapies and who may be more likely to benefit from a precision treatment approach.²

For instance, in August 2026, the U.S. Food and Drug Administration (US-FDA) extended the authorized use of Illumina's TruSight Oncology Comprehensive assay as a companion diagnostic in thyroid cancer. It reports tumor mutational burden (TMB) and microsatellite instability (MSI) and identifies patients with RET (REarranged during Transfection proto-oncogene) alterations in thyroid cancer who can benefit from selpercatinib, illustrating how NGS platforms are increasingly being connected to specific therapeutic decisions.³

For biopharma innovators, however, technological capability is only the starting point. The strategic questions are increasingly around clinical utility, adoption, differentiation, evidence, access and value.

Moving from Genomic Alterations to Epigenetic Biomarkers

Proteogenomics integrates genomic, transcriptomic and proteomic data to provide additional insight into treatment response and resistance.⁴, ⁵ Patient-derived organoids (PDOs) provide a complementary approach for assessing treatment response.⁶ - ⁸ The latest research has demonstrated the potential of leveraging PDOs to connect molecular characterization with functional treatment selection.⁶, ⁷, ⁹

For diagnostic and biopharma companies, the value of these approaches extends beyond understanding tumor biology. Integrating functional molecular insights can help identify responsive patient groups, guide treatment development, enable robust evidence generation and support differentiation in an increasingly competitive oncology landscape.

Liquid Biopsy: Moving Molecular Testing Beyond Tissue

Liquid biopsy is an emerging area of innovation, enabling non-invasive molecular profiling and repeated monitoring of molecular changes over time using circulating tumor DNA (ctDNA) from blood.¹, ¹⁰, ¹¹

Minimal residual disease (MRD) is another emerging application of liquid biopsy. In May 2026, the US-FDA approved Signatera CDx as a companion diagnostic for identifying MRD in muscle-invasive bladder cancer patients, thus integrating ctDNA-based MRD testing into clinical care.¹², ¹³

But the emergence of liquid biopsy also creates a new set of market and clinical questions:

For manufacturers, understanding these dynamics is equally important as understanding the technological principles themselves.

The Next Frontier: Multi-Cancer Detection

The innovation landscape is expanding beyond individual biomarkers and specific cancer types. Multi-cancer detection (MCD) technologies are being investigated as blood-based approaches that may identify biological signals, including DNA or RNA changes, methylation patterns, and DNA fragmentation profiles, associated with multiple cancers.¹⁴

Thus, a minimally invasive test capable of detecting multiple cancer-associated signals could reshape elements of the screening and diagnostic pathway.

However, MCD tests’ effectiveness in screening asymptomatic populations is currently being researched. A positive MCD result is not a cancer diagnosis and requires follow-up testing.¹⁴ This distinction highlights the gap that can exist between the promise of emerging innovations and demonstrated clinical use.¹⁵

For biopharma and medtech manufacturers, MCD testing also brings new considerations for patient and clinical decision-making. A positive result may cause uncertainty for patients, as it does not confirm cancer and requires further testing. Physicians will play a critical role in interpreting results, communicating uncertainty and guiding follow-up, while clear communication from test developers will be essential to help patients and clinicians understand what results mean and what they do not.

Biomarkers in Clinical Trial Design

Biomarkers are increasingly shaping oncology trial design.⁹

As biomarkers move toward clinical use, validated assays, prespecified biomarker strategies and appropriate statistical plans become increasingly important for regulatory development, especially when biomarker status affects eligibility, endpoints or treatment evaluation.

Where Innovation Meets the Real World

A diagnostic can demonstrate strong analytical and clinical performance yet face challenges in routine practice. Physician awareness, existing clinical workflows, testing infrastructure, reimbursement, patient acceptance, accessibility, competing technologies and stakeholder-specific value perceptions can all influence adoption. Thus, the critical question is no longer simply:

but:

For oncology manufacturers, stakeholder and market intelligence is therefore critical. Qualitative research with oncologists can uncover unmet needs, testing behaviors, workflow friction and perceptions of emerging technologies, while quantitative research can validate these findings across larger stakeholder segments and assess adoption potential.

KOL and expert consultations provide deeper perspectives on evolving clinical pathways and technologies, while segmentation identifies physician or institutional groups most likely to adopt an innovation early. Competitive intelligence tracks emerging brands, competitors’ clinical pipelines, positioning and go-to-market strategies. Market sizing and market-potential assessment quantify the opportunity by integrating epidemiology, market growth, competitive intensity, healthcare infrastructure and reimbursement.

Together, these capabilities provide a broader view of market trends and what could drive adoption, beyond simply identifying competitors.

From Market Insight to Evidence and Value

For innovative diagnostics, market intelligence is a part of the evidence journey. As technologies move toward broader adoption, stakeholders increasingly need evidence of real-world clinical outcomes and economic value.

Real-world evidence (RWE) provides insight into outcomes, safety, resource utilization and workflow impact in routine practice, helping organizations understand how innovations perform beyond controlled research environments and influence care pathways.

Health economics and outcomes research (HEOR) extends this evidence by evaluating broader value through cost-effectiveness, budget impact, patient-reported outcomes, usability studies and HTA-ready evidence packages. These capabilities can help translate clinical and real-world findings into evidence relevant to reimbursement and market-access decisions.

Connecting the Oncology Ecosystem

Oncospective,¹⁶, ¹⁷ CETAS Healthcare's oncology-focused insights offering, complements this evidence pathway through CETAS's broader capabilities in market intelligence across Diagnostics, MedTech and Oncology, supported by custom market research, competitive intelligence, KOL and expert consultation, regulatory support, and rapid healthcare professional surveys.

For rising biomarker and diagnostic innovators, these capabilities can address market opportunity, competitive landscaping, physician perspectives and patient clinical pathways, segmentation, adoption barriers and evidence requirements.

At Oncospective by Cetas, we provide biopharmaceutical teams with a direct line of sight into the decision-making of medical oncologists, surgical oncologists, cancer patients, and all other stakeholders contributing to cancer care. We do this by asking them the right questions, not just the ones on the surface.