Industry partnerships are crucial for more than just funding. Collaborating with pharmaceutical companies provides translation-focused questions that guide the design of advanced cell models, ensuring they are predictive, scalable, and compatible with real-world development workflows.

Data from trials like Niagara suggests a powerful new paradigm for assessing treatment success. Combining urine tumor DNA (uTDNA) for local disease and circulating tumor DNA (ctDNA) for systemic relapse offers a more dynamic view than traditional pathology and is poised to become the superior surrogate endpoint in bladder cancer trials.

While the need for prospective trials dominates the ctDNA discussion, a more fundamental obstacle is the lack of standardization between assay types (e.g., tumor-informed vs. agnostic). Without a common measurement approach, data from disparate trials cannot be pooled to create a universally accepted surrogate endpoint for regulatory approval.

Experts praise cooperative groups (e.g., Chartered, Stampede) for conducting large studies and preserving samples for future biomarker research. These publicly funded efforts can address fundamental clinical questions that industry-sponsored trials may not prioritize, ultimately advancing the field.

Dr. Deb Schrag suggests the main challenge for new molecular cancer screening technologies is not invention, but implementation. The critical task will be deploying these tools at a population scale and effectively managing the logistical challenge of distinguishing true positives from false alarms.

While not yet validated, ctDNA is being used by clinical experts as a de-escalation tool to provide confidence when stopping long-term maintenance therapies like PARP inhibitors. This novel application focuses on reducing treatment burden rather than solely detecting disease progression.

The INTERCEPT study found only 2% of ctDNA-positive colorectal cancer patients clear the marker without intervention. This stable, high-risk baseline allows small trials to use ctDNA clearance as a rapid endpoint, potentially accelerating the development of new adjuvant therapies.

Despite significant interest, circulating tumor DNA (ctDNA) is not yet an actionable tool for guiding the duration of maintenance immunotherapy in endometrial cancer. While studies like DuoE show ctDNA levels correlate with outcomes, there is no evidence to support using its clearance to decide when to stop treatment. It remains a prognostic, not a predictive, biomarker for this purpose.

With over 5,000 oncology drugs in development and a 9-out-of-10 failure rate, the current model of running large, sequential clinical trials is not viable. New diagnostic platforms are essential to select drugs and patient populations more intelligently and much earlier in the process.