Precision Redefined: AI, Liquid Biopsy, and Theranostics at the Forefront of Oncology Innovation
Author:
Mauricio Scarcello, Director, Strategic Delivery & Growth
Inside KoNECT 2025: Key Insights Driving Oncology Transformation
The oncology landscape is undergoing a paradigm shift driven by data-enabled precision medicine, adaptive trial designs, and theranostic strategies. This blog synthesizes insights from the 2025 KoNECT International Conference held in Seoul from September 22-24, 2025, highlighting five transformative pillars: AI-powered pathology, liquid biopsy integration, radioligand therapy, histopathology standardization, and diagnostics as regulatory accelerators. These innovations collectively redefine clinical development, regulatory pathways, and patient outcomes.
1. AI based digital pathology: Form subjectivity to standardization
Manual biomarker assessment in pathology is inherently subjective, introducing variability that compromises trial reproducibility. AI-driven digital pathology addresses these limitations by delivering quantifiable, reproducible biomarker data, enabling robust patient stratification and predictive modelling for personalized therapy.
2. Liquid Biopsy: The New Clinical Compass
Traditional tissue biopsies provide static snapshots of tumour biology. Liquid biopsy (LB) offers a dynamic, minimally invasive alternative, enabling real-time tumour profiling, early detection of resistance, and adaptive treatment strategies. Its integration into early-phase trials enhances patient selection accuracy and accelerates timelines, making it pivotal for precision oncology .
3. Theranostics and Radioligand Therapy: Dual Power of Diagnosis and Treatment
Radioligand therapy (RLT) and peptide receptor radioligand therapy (PRRT) exemplify theranostics, merging diagnostics with targeted radionuclide therapy. These modalities deliver highly selective radiation to tumours, minimizing systemic toxicity and improving outcomes in solid tumours.
4. Histopathology: The Translational Bridge
Histopathology remains a cornerstone of drug development, linking diagnostic precision to therapeutic impact. Standardization across global sites ensures data integrity, enabling regulators and sponsors to trust trial endpoints.
5. Diagnostics as a Regulatory Accelerator
Companion diagnostics and biomarker-driven strategies are now regulatory imperatives, not optional add-ons. Aligning diagnostics with therapeutic development accelerates approvals, enhances patient stratification, and improves global trial success rates.
Discussion and the Future of Oncology Innovation
The convergence of AI, liquid biopsy, and theranostics signals a future where oncology innovation is data-driven, globally harmonized, and patient-centric. These technologies are not isolated breakthroughs—they form an interconnected ecosystem that will define the next decade of cancer care.
Key challenges remain: regulatory harmonization, data interoperability, and scalable infrastructure for digital and molecular diagnostics. Addressing these will determine whether the promise of precision medicine translates into global patient benefit.
Fortrea at KoNECT: Accelerating Precision Oncology with Liquid Biopsy Integration
Fortrea's luncheon session showcased its leadership in transforming oncology clinical trials through the early integration of liquid biopsy technologies. As the oncology landscape shifts toward precision medicine, liquid biopsies are redefining how trials are designed and executed—enabling real-time, non-invasive tumor profiling, earlier diagnosis, and dynamic monitoring of minimal residual disease (MRD).
Fortrea’s Diagnostics Center of Excellence (Dx CoE) and deep oncology experience stands at the forefront of this evolution, offering deep expertise in biomarker-driven diagnostics and regulatory mastery across global frameworks. By integrating liquid biopsy strategies into clinical trial workflows and customer data platforms (CDP), Fortrea ensures traceability, real-time biomarker monitoring, and compliance with evolving regulatory standards such as EU IVDR and FDA IDE/PMA pathways.
The presentation highlighted Fortrea’s operational excellence, strategic site selection, and robust training programs, which have accelerated trial timelines and improved data quality. A recent mega trial in cancer screening—enrolling over 78,000 patients across six countries—demonstrated Fortrea’s ability to surpass FDA-defined diversity and inclusion targets, achieve rapid enrollment, and maintain high sample integrity.
Fortrea’s integrated approach bridges sponsor needs with site and patient-centric considerations, driving innovation in precision oncology and setting new standards for clinical trial efficiency. Their contribution to KoNECT underscores the importance of early liquid biopsy adoption—not only for operational and regulatory success, but for advancing patient care and outcomes in oncology research.