--- title: "Designed for a Moving Target: Building Oncology IVD Programmes That Survive Scientific Change" description: "For founders, CSOs, and regulatory leads at oncology IVD companies operating in fast-evolving biomarker landscapes." url: https://qbdgroup.com/en/blog/oncology-ivd-scientific-change-strategy type: "Blog post" language: en published: 2026-07-08 author: "Annelies Rotthier" category: "Clinical" publisher: "QbD Group" citation: "QbD Group, \"Designed for a Moving Target: Building Oncology IVD Programmes That Survive Scientific Change\", https://qbdgroup.com/en/blog/oncology-ivd-scientific-change-strategy" --- # Designed for a Moving Target: Building Oncology IVD Programmes That Survive Scientific Change > For founders, CSOs, and regulatory leads at oncology IVD companies operating in fast-evolving biomarker landscapes. For founders, CSOs, and regulatory leads at oncology IVD companies operating in fast-evolving biomarker landscapes. An oncology IVD development programme usually runs longer than the scientific landscape it was designed against. By the time your oncology IVD reaches certification, the science it was built for may have already changed. A single biomarker test can, by the end of its clinical performance study, face a field in which multi-marker panels have become standard. A tissue-based assay can launch alongside liquid biopsy approaches that didn't exist when you wrote your protocol. A prognostic marker can be reframed as predictive, or absorbed into a composite signature, before your first sale. This is not the exception in oncology biomarker science. It is the operating environment, and it is one of the things early-stage IVD founders underestimate. Preparing for scientific change calls for technical, regulatory, and clinical disciplines that differ from those needed to develop a static product. These disciplines have to be built in from the outset. ## An Evolving Landscape The progression visible across oncology IVDs over the last decade is consistent in direction, even when individual steps vary by indication. Single-marker assays are extended into multi-marker panels. Multi-marker panels are reframed as pathway signatures. Signatures become composite scoring algorithms such as Tumour Mutational Burden. Tissue-based testing is augmented, and in some indications displaced, by liquid biopsy and multi-modal diagnostics. Clinical utility expectations widen continuously, moving from diagnosis to prognosis, to therapy selection, and on to longitudinal monitoring. At the same time, technology continues to evolve. Assays become more sensitive, less invasive sample types are used, artefacts due to sample processing are improved. Each of these shifts changes the standard of care against which a new IVD must demonstrate clinical performance. A device can reach the original clinical performance specifications, and still have lost its clinical utility. ## Three Disciplines That Buy Time Against Change Three disciplines, applied throughout the development programme will make the oncology IVD more robust within an evolving landscape. ### State of the Art as a discipline, not a deliverable. Under IVDR, the State of the Art is a required component of the Performance Evaluation Plan. In a static field, this is a one-time literature analysis. In oncology, it is an ongoing exercise. The State of the Art set at study design has to be revisited at each major programme milestone, and the Performance Evaluation Report has to show that the golden standard, the clinical context, and the field consensus remain up-to-date. ### Risk management as a strategic process, not a compliance process. ISO 14971 risk management is required, and is usually treated as a hazard-analysis exercise focused on patient safety. In oncology IVD development, it is also the discipline through which technology obsolescence, biomarker displacement, comparator evolution, and standard-of-care drift are tracked and acted upon. Each risk identified should drive specific mitigations in the technical strategy. Examples include pre-specified data collection that supports later expansion of claims, design choices that preserve optionality, defined trigger points for revisiting earlier decisions, and active monitoring of competing technologies. ### Intended purpose as a revisitable decision. Once locked for a specific clinical performance study, an intended purpose statement is hard to change. But the broader strategic positioning behind it (which indication, which population, which intervention point in the pathway) can and should be tested against current scientific reality at defined intervals. The discipline is to plan those reviews into the programme, to base them on data rather than instinct, and to act on them when needed, rather than discovering at certification that the original positioning no longer reflects current practice. ## What This Looks Like in Practice Three specific processes distinguish programmes that absorb scientific change well from programmes that get overtaken by it. ### Competitor and Technology Monitoring First, competitor and technology monitoring built into programme governance. New publications, emerging platforms, and shifts in standard of care are tracked intentionally, with a defined cadence and specific people accountable. The cost of building this into the programme is small. The cost of operating without it is occasionally programme-defining. ### Forward-Looking Data Collection Second, data collection that supports more than the immediate primary endpoint. Clinical performance studies can be designed to capture data that supports later expansion of intended purpose, addition of secondary indications, or response to scientific shifts in the field. This requires foresight at protocol design, and it is often the difference between an evidence base that becomes more valuable with time and one that becomes obsolete with time. ### Technical Documentation Built to Evolve Third, technical documentation built to evolve. The Performance Evaluation Report, the technical file, and the State of the Art analysis should be structured so that updates can be incorporated without re-architecting the documentation each time the field moves. The change-control discipline that handles scientific evolution sits in the Quality Management System, and its design determines how quickly the programme can respond when it must. ## Key Takeaways Oncology IVD development is unusual in that the scientific, clinical and technological landscape against which a product is judged at certification may be materially different from the landscape it was originally designed against. Programmes that recognise this from the outset, and build the technical, regulatory, and quality disciplines to absorb it, reach the market with an evidence base and a positioning that are still current. Programmes that do not find themselves at certification defending a design against a clinical reality that has moved on. The discipline is to plan the programme not against the science of today, but against the science of the day the product reaches the market. That endpoint is unknowable in its detail, yet predictable in its direction. > *"The founders who get oncology IVDs to patients fastest are not the ones with the best technology. They are the ones who understand the full journey, and plan for all of it."* > > — Closing takeaway from the QbD Group webinar ## Watch the Full Session This article draws on a recent QbD Group webinar with Annelies Rotthier, PhD (Business Unit Manager, IVD CRO and Clinical Evidence Services at QbD Group) and Egbert Smit, PhD MBA (CEO, MLA Diagnostics). They walk through the full programme of early decisions that lock a development path, the clinical evidence strategy that follows, and the disciplines that distinguish programmes reaching the market with a current, defensible evidence base. [Watch the on-demand webinar](/en/webinars/oncology-ivd-market-faster-what-founders-underestimate) --- Source: https://qbdgroup.com/en/blog/oncology-ivd-scientific-change-strategy — © QbD Group. 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