Transformative microsystems for Cancer Diagnosis, treatment monitoring, and clinical integration: Outcomes from an NCI Workshop.

Abstract

The National Cancer Institute (NCI) convened a three-day virtual workshop, Transformative Microsystems for Cancer Diagnosis, Treatment Monitoring, and Clinical Integration (September 23-25, 2025). The meeting assembled experts from government, academia, and industry to discuss how microphysiological systems (MPS), tumor- and organ-on-a-chip devices, and integrated liquid-biopsy platforms are reshaping oncology. Sessions explored innovation, translational implementation, clinical usability, and policy barriers. This commentary outlines a roadmap for bridging biology, computation, and device design to transform microsystems from experimental tools into integrated components of personalized cancer care. The workshop consensus was that the next phase of innovation must focus on reproducibility, scalable and quality-controlled manufacturing, and clinical usability. FDA clearance alone does not guarantee patient access to microsystem diagnostics or improved outcomes, and early engagement with payers is essential to ensure validated technologies meet cost-effectiveness criteria for insurance coverage. Collaboration with end-users early in the design process is also essential as poor usability is a primary cause of product failure. Key barriers to clinical translation include a lack of consensus standards (e.g., leakage testing, flow-rate calibration, sensor validation) and availability of biobank materials for validating translational microsystem technologies.