Why Commercial Strategy Must Step Up to Unlock Biomarker Testing and Actionability

ASCO 2025 may not have delivered the dramatic, headline-making breakthroughs of previous years. However, for commercial teams in pharma and biotech, it offered something far more valuable. A clear signal of where oncology is heading - and what it will take to stay competitive. That is: biomarker testing and actionability.

Precision medicine is no longer a future ambition. It’s the present reality. And ASCO 2025 confirmed that the commercial success of oncology therapies now hinges on how well companies can navigate a rapidly evolving diagnostic and data ecosystem.

Drawing on their expert analysis and firsthand experience at ASCO 2025, Susanne Munksted and Kevin Entwistle identify five key trends that emerged from this year’s meeting. And what they mean for your commercial strategy.

Precision medicine is now the standard, and biomarker testing is the compass

The language of precision medicine has become mainstream. Biomarkers are now discussed with the same frequency and weight as traditional endpoints like progression-free survival (PFS) and overall survival (OS). This shift reflects a broader industry transformation. That is to say, precision medicine is no longer a specialized niche - it’s the foundation of modern oncology. And biomarker testing makes a huge impact on how to match a patient with the right treatment pathway.

Kevin Entwistle, VP of Precision Medicine Strategy, Diaceutics

“The industry’s understanding of precision medicine has evolved. It’s now focused on action - on what we can do to move the needle.”

For commercial teams, this means that every launch strategy must now include a diagnostic strategy. A precision-first mindset must drive the patient journey map. From awareness, availability, and adoption, to access and action. Biomarker testing will form a big part of this.

Data trends powering oncology progress

While ASCO 2025 lacked the dramatic data reveals of years past, it delivered a steady stream of meaningful clinical insights. Trials like SERENA-6, MATTERHORN, and AMPLITUDE may not have made headlines. Yet they are certainly reshaping treatment paradigms in breast, colon, and prostate cancers.

These studies signal a shift in requirements. Treatment sequencing, or biomarker testing and stratification - all have direct implications for market access, physician education, and patient identification. Importantly, these insights are signalling a broader shift in oncology. Patients can access life-changing therapies earlier in their disease course. And this may, of course, potentially improve outcomes and redefine standards of care.

The ADC pipeline is surging, and diagnostics must keep up

Antibody-drug conjugates (ADCs) were a major focus at ASCO 2025. Particular emphasis was on new agents targeting HER2, HER3, DLL3, SEZ6, and Nectin-4. This explosion of innovation is exciting - but it also introduces significant complexity.

Each new ADC often requires a specific immunohistochemistry (IHC) test, with unique clones, cutoffs, and scoring algorithms. This creates a fragmented diagnostic landscape that can slow adoption and confuse clinicians.

Kevin Entwistle:

“We’re seeing a repeat of the PD-L1 scenario: different drugs, different clones, different scoring algorithms. Accuracy and concordance are critical.”

For commercial teams, the takeaway is clear: diagnostic readiness must be built into launch planning from day one. That includes partnerships with diagnostic developers, education for pathologists, and strategies to ensure tissue availability and test standardization.

ctDNA and MRD are moving from research to routine

Circulating tumor DNA (ctDNA) and minimal residual disease (MRD) detection are no longer emerging technologies. They are becoming essential tools in oncology care. ASCO 2025 featured compelling data from studies like MONSTAR-SCREEN-3 and DYNAMIC-III. These data sets demonstrate ctDNA’s ability to guide adjuvant therapy, monitor treatment response, and predict recurrence.

Susanne Munksted, Chief Precision Medicine Officer, Diaceutics:

“This is no longer just a research tool. ctDNA is informing real-world treatment decisions - and commercial teams need to plan accordingly.”

The implications are significant. Pharma companies must now make smarter, more holistic decisions during clinical development. Decisions that proactively lay the groundwork for global ctDNA testing availability at launch.

Digital pathology is driving demand for scalable infrastructure for routine clinical adoption

Computational pathology and AI were once seen as futuristic add-ons. Today, they are becoming essential components of diagnostic workflows. Particularly in the context of biomarker testing, complex biomarkers, and limited tissue availability.

ASCO 2025 showcased how AI is being used in testing. From interpreting IHC stains, predicting biomarker status, to H&E slides, and support pathologists in identifying patients for targeted therapies. In some cases, AI is the only viable method for detecting certain biomarkers, making it a gatekeeper for therapy access.

Kevin Entwistle:

“We’re seeing a repeat of the PD-L1 scenario: different drugs, different clones, different scoring algorithms. Accuracy and concordance are critical.”

For commercial teams, this means thinking beyond the drug and beyond the test itself. It means planning for technologies that make AI-enabled diagnostics possible at scale. These include scanning, digitization, and cloud-based platforms.

What this means for commercial strategy

ASCO 2025 confirmed that the future of oncology is precision-driven, diagnostics-enabled, and data-powered. For commercial and medical affairs teams, this means:

• Investing early in diagnostic strategy - including test development, access, and education. With an emphasis on biomarker testing.
• Collaborating with diagnostic partners to build globally scalable, launch-ready infrastructure. Not just U.S.-centric solutions.
• Laying the groundwork for AI and digital pathology. Addressing the infrastructure gaps that limit routine clinical adoption.
• Translating clinical insights into action. Not just for physicians, but across the entire commercial ecosystem.