Insights from the AMDM IVD Focus Meeting highlight opportunities to reassess regulatory pathways, leverage existing evidence and refine CDx development strategies.
SVP, Chief Revenue Officer
Regulatory changes can reshape a companion diagnostic development program. Their practical value depends on how sponsors translate those changes into an evidence strategy that supports the test’s intended use.
The recent AMDM IVD Focus Meeting highlighted several connected themes around regulatory evolution, clinical evidence and diagnostic development. Most notably, the regulatory environment is evolving in ways that may create more streamlined regulatory pathways for certain companion diagnostic technologies. Together, these themes reinforced the importance of considering the diagnostic workstream alongside the therapeutic program.
For sponsors, the implications extend beyond the submission pathway. Existing data, specimen availability, assay transitions and clinical study decisions all influence how a companion diagnostic program advances. Four considerations stand out.
Understand where regulatory changes apply
The regulatory changes discussed at AMDM are at different stages. FDA’s final order reclassifying specified oncology in situ hybridization (ISH) test systems from Class III to Class II took effect on September 16, 2026. A separate proposal, published November 25, 2025, would reclassify specified oncology nucleic acid-based test systems, including PCR and NGS technologies. That proposal remained pending at the time of the meeting, making the distinction between an effective change and a potential future pathway important for sponsor planning.
These changes concern specific device types rather than companion diagnostics as a whole. A change affecting one test technology does not establish the pathway for another, and regulatory streamlining does not eliminate the need for clinical evidence.
For sponsors considering a new diagnostic strategy or reassessing an existing program, the practical starting point is to determine whether the relevant change applies to the proposed test. From there, the regulatory pathway and evidence requirements can be considered together.
For sponsors with programs potentially affected by these changes, the evolving regulatory landscape creates an opportunity to reassess development strategies that may have been built around older regulatory assumptions. Where a change applies, it may reduce some of the historical burden of the pathway, and the program should be revisited with a clear understanding of what has changed and what it still has to demonstrate. A potentially different pathway is one input into that assessment; intended use, the target population and the evidence supporting performance remain central.
Assess existing evidence before defining the next study
Another theme in the meeting takeaways was the value of planning the overall evidence package before committing to an additional study.
Companion diagnostic development may draw on prospective studies, retrospective analyses, bridging and other supportive evidence. The appropriate combination depends on the program and on what existing data and specimens can contribute.
Sponsors should not automatically assume the next answer is another prospective study. An early look at existing clinical data, banked specimens, retrospective opportunities and potential bridging strategies can establish what is usable, identify true gaps and clarify where additional work is warranted. In some programs, that assessment reveals a more efficient evidence path and helps avoid studies that add time and cost without answering a new question.
The assessment also brings clinical, regulatory and statistical considerations into the same discussion. Intended use, population, endpoints and data requirements influence which evidence is relevant and how it can be evaluated.
The sponsor implication is practical: define the questions the evidence must answer, then determine how existing and planned work can address them. That sequence helps give each study a clear role within the broader development program.
Plan specimens and assay transitions early
Evidence strategy depends on execution. The meeting takeaways identify laboratories, specimens and vendors as central components of companion diagnostic development, alongside the importance of clinical bridging.
For sponsors, the trial assay, the commercial assay, the specimen strategy and the bridging plan are linked decisions. They come down to two planning questions: whether the necessary specimens are available, and how evidence generated using a trial assay will support the final or commercial assay.
An assay transition can create a need to evaluate concordance and establish an appropriate bridging strategy. Specimen availability and testing logistics are therefore part of the evidence plan itself, rather than simply activities to organize after study decisions are made. If specimen needs are not considered early, availability can become a limiting factor later in development, narrowing the options for concordance testing and bridging to the commercial assay.
Considering these elements together helps sponsors identify dependencies earlier. Available data may point toward a particular analysis, but its feasibility also depends on access to suitable specimens and coordination with the laboratories performing the testing.
Bringing specimen workflows, assay plans and statistical considerations into development discussions gives the team a clearer view of what the proposed evidence strategy will require in practice.
Give the diagnostic workstream clear ownership
A companion diagnostic remains a distinct development workstream even when it sits within a larger therapeutic program.
The meeting takeaways highlight the coordination involved: diagnostic evidence strategy, clinical validation, sites and laboratories, specimens, data management, biostatistics and bridging. These activities connect with the therapeutic trial, while retaining their own requirements.
In practice, this workstream can easily become fragmented. When the therapeutic CRO is managing the broader trial but does not have specialized diagnostic capabilities, activities such as specimen management, laboratory coordination, clinical validation and bridging can fall between teams, with no single group accountable for the diagnostic evidence package.
The implication for sponsors is direct: the diagnostic workstream needs clear ownership and specialized expertise managing those activities alongside the therapeutic trial. Defining who owns diagnostic decisions, how they are coordinated with the therapeutic program and where dependencies sit should happen early, before gaps surface in the evidence.
Expertise that connects evidence and execution
Beaufort brings deep IVD experience and specialized companion diagnostic expertise to help sponsors put these considerations into practice. Our team supports evidence assessment, clinical validation, specimen and laboratory strategy, bridging, data management and biostatistics. By bringing these capabilities together under clear diagnostic ownership, Beaufort helps sponsors manage the diagnostic workstream alongside the therapeutic trial and keep evidence strategy connected to execution.