CLINICAL TRIALS
Identify and stratify for trial eligibility before ordering a single confirmatory stain.
Precision medicine and biomarker-driven therapies depend on evaluating multiple markers for trial enrollment and stratification. However, physical IHC adds cost, delays enrollment, and introduces interobserver and intraobserver variability.
Virtual staining predicts biomarker status directly from the H&E slide already collected at screening, reducing observer variability, narrowing the candidate pool, and supporting patient stratification before a confirmatory physical stain is ordered.
For Research Use Only.
case study
A virtual CCNE1 biomarker matched physical IHC at the single-cell level, predicted from H&E alone.
From a study on gynecological tumors with Debiopharm, presented at AACR 2026.
69
Patient tumor samples
1
Virtual biomarker (CCNE1)
Single-cell
Resolution
0.89
ROC AUC
The study validated a virtual biomarker model to predict CCNE1 expression directly from an H&E whole slide image. The model was trained and validated across two gynecological tumor types. Results showed CCNE1 prediction at the per-cell level, with high concordance against the reference standard of physical IHC.
This approach reduces testing time, addressing the testing bottlenecks that currently delay enrollment, and preserves tumor tissue for confirmatory and downstream molecular testing.
applications
Patient Stratification
Identify eligible patients by biomarker status directly from the H&E slide already collected at screening.
Trial Enrollment
Reduce testing bottlenecks that delay enrollment, without waiting on a sequential stain queue.
Companion Diagnostics
Test candidate biomarkers computationally to support CDx development.
Screen Failure Reduction
Narrow the candidate pool before a confirmatory physical stain is ordered, reducing unnecessary screening cost.
Resources
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