HER2 Testing Bottlenecks Were Slowing Breast Cancer Trials in Chile - TrialHub Caught It
The barrier
HER2 status drives eligibility for a huge share of breast cancer trials, but the diagnostic pathway isn’t uniform across sites. Status is first assessed via immunohistochemistry (IHC); any equivocal (2+) result triggers a confirmatory in situ hybridization (ISH test), and here’s where site selection breaks down. Some sites still rely on manual Fluorescence In Situ Hybridization (FISH) testing, a process that runs over 1,200 minutes per test and costs an estimated $265.67 USD per unit. Others have moved to automated Dual In Situ Hybridization (DISH) testing. On paper, both sites look equally “HER2 testing capable.” In practice, one can process patients in a fraction of the time and cost of the other, and that gap doesn’t show up in standard feasibility assessments.
The insight
Patient Journey data surfaces this kind of disease- and country-specific nuance instead of treating “HER2 testing” as a single uniform step. It identifies the specific patient population that will hit the IHC-equivocal branch and require ISH confirmation, and flags that automated DISH testing is the faster, lower-cost path through that branch. That lets sponsors and site teams route eligible patients toward automated testing from the outset, rather than defaulting to the slower manual FISH workflow.
The outcome
Automated testing delivers an estimated 13% cost reduction per test versus the manual FISH process — and cuts out the multi-hour turnaround that manual FISH requires. For a HER2-positive breast cancer trial, that translates directly into faster diagnostic confirmation, faster enrollment, and site selection decisions grounded in real infrastructure, not assumptions.
Impact on client: Site selection and feasibility