Inconsistent histology and immunohistochemistry are common sources of irreproducible biomarker data and delayed decisions in translational programs. Histology and IHC failures often stem from pre-analytical variability, antibody selection errors, and QC gaps that compromise assay reliability. This consulting service focuses on designing robust, defensible workflows that reduce non-specific staining, improve reproducibility, and ensure interpretable results.
Our approach is informed by hands-on operational experience across histopathology and IHC workflows—from FFPE processing and sectioning to staining optimization and quality control. We understand how these processes function in practice, not just in theory, which means we can identify failure points before they compromise data quality and design solutions that work within real laboratory constraints.
Histology and IHC quality directly impacts biomarker confidence, study reproducibility, and reduced rework. Non-specific staining, batch-to-batch variability, and inconsistent interpretation create downstream consequences that invalidate comparisons, require expensive protocol redevelopment, and delay regulatory submissions.
These failures often surface during late-stage analysis when sample collection is no longer possible, forcing entire cohorts to be excluded or protocols to be redesigned from scratch. The result: lost investment, compromised biomarker programs, and delayed timelines that derail study objectives.
Protocol framework with antibody selection rationale, control strategy, and optimization approach that reduces non-specific staining and improves reproducibility
Specific failure points identified with actionable recommendations that restore staining quality and interpretability
Review of tissue handling, processing, and QC integration with failure-point annotations that prevent batch effects and variability
Pre-analytical and analytical variables that compromise staining quality, with prioritized mitigation steps that protect assay reliability
Prioritized rollout plan with decision points and resource requirements that ensures consistent execution across teams and sites
We advise not only on what to run, but on what not to pursue when signal ambiguity or tissue limitations would compromise interpretation. Our approach emphasizes judgment calls over routine optimization, addressing risks of lot-to-lot variability, non-specific signal, and biological mismatch that can invalidate results.
Defined checkpoints throughout the workflow that catch variability before it compromises results
Framework for tracking protocol consistency over time that prevents uncontrolled changes from introducing variability
Standardized approach to reading and scoring that reduces inter-reviewer variability and improves data consistency
Non-specific binding or off-target signals that lead to incorrect program decisions and wasted resources. This is one of the most critical failure modes—staining that appears correct but lacks biological relevance can mislead entire research programs.
Batch-to-batch variability from uncontrolled pre-analytical or analytical factors that compromise study conclusions
Lack of scoring criteria or control strategy that creates data quality issues and requires expensive re-analysis
Misaligned assay design that fails to address the biological hypothesis and wastes time and resources
Uncontrolled changes in fixation, processing, or staining that compromise data integrity and require protocol redevelopment
Initial assessment and protocol review: 3–5 days. Assay design or troubleshooting report: 1–2 weeks. Control strategy and implementation roadmap: 3–5 days. Total engagement typically 2–4 weeks depending on complexity.
Our guidance is informed by hands-on experience working within histology and IHC workflows, where small technical decisions can materially affect interpretability, reproducibility, and study timelines. This operational perspective enables us to identify failure points before they compromise data quality and design solutions that work within real laboratory constraints.
A systematic 3-step methodology that transforms IHC challenges into robust, defensible workflows.
Protocol framework with antibody selection rationale, control strategy, and optimization approach
Methodical testing approach that identifies optimal conditions for signal-to-noise ratio
Systematic validation with QC checkpoints ensuring reproducibility and interpretability
Discuss an IHC Assay Review or Request a Project Estimate
Request an IHC Assay Review →We review your study goals, available tissues, existing protocols, and constraints. This initial assessment identifies gaps, risks, and optimization opportunities.
We evaluate your current workflows, sample handling, assay performance, or pathology data quality. This identifies failure modes and decision points.
We deliver concrete outputs—protocols, SOPs, review reports, or workflow frameworks—with implementation guidance and follow-up support as needed.
Troubleshot persistent non-specific staining for an exploratory biomarker panel, saving 4 weeks of rework.
Designed a de-risked IHC validation framework for a California biotech's IND-enabling program.
Reduced lot-to-lot antibody variability for a high-volume diagnostic project through rigorous control strategies.