Two new companion-diagnostic validations support broader pembrolizumab eligibility in dMMR/MSI-H solid tumors, with post-marketing bridging data confirming that two commercially available companion diagnostics can reliably identify patients matching the trial assay logic. The BMC Cancer study highlights how regulators evaluate CDx performance when testing platforms in routine care differ from those used in pivotal trials. Separately, Bile sequencing is moving toward earlier cancer detection: an ERCP bile-cell-free DNA study reported pancreatobiliary cancer detection with high specificity and signaled malignancy a median of 38 days before conventional diagnosis. The approach could shorten time-to-decision for patients where biopsy timing and access complicate staging. Together, the findings underscore a growing split between tumor-agnostic drug approval pathways and the practical need to prove diagnostic equivalence across real-world workflows—especially for patients transitioning from trial environments to routine imaging and sampling.