PathologyEdge Consulting
Rapid Turnaround Available

Expert Pathology Review

Independent pathology review and biomarker interpretation for biotech and pharma programs where data quality and scoring accuracy drive development decisions.

Oncology Biomarkers
Technical Quality QC
IND-Enabling Programs

Deliverables

Pathology review report

Expert evaluation with findings, interpretation, and recommendations

Biomarker scoring and interpretation

IHC/IF analysis with clinical context

Assay quality assessment

Technical evaluation of staining quality and protocol performance

Program review document

Strategic assessment of biomarker or diagnostic program

Follow-up consultation

Discussion of findings and implementation guidance

Inputs Required

Slides or digital images (H&E, IHC, IF)
Clinical context and study goals
Protocol information (if reviewing assay performance)
Specific questions or review objectives
Timeline requirements

Turnaround Commitment

3-5 Days
Case Review
Standard pathology case evaluation
1-2 Weeks
Program Review
Strategic program assessment
1-2 Weeks
Complex Analysis
Advanced biomarker interpretation

Rush turnaround available for urgent cases.

Risk vs. Solution

Misinterpreted biomarker data

Prevents incorrect program decisions and wasted clinical spend

Overlooked technical issues

Identifies assay problems that invalidate results before they impact development

Inconsistent review standards

Eliminates variability that creates data quality issues and regulatory concerns

Program misalignment

Ensures biomarker strategies support development goals and regulatory requirements

Regulatory gaps

Identifies pathology data issues that don't meet submission requirements early

Professional Notice

This is an advisory and consulting service. PathologyEdge does not certify, accredit, or approve laboratories. We do not operate as a clinical laboratory or provide regulatory approval services.

Review reports are intended to support internal decision-making and operational consistency. Our assessments are based on industry best practices and operational experience, structured to support program decisions.