Flagship is the only independent tissue analysis and pathology service provider spanning the entire histopathology process.

Our Services:

Flagship Report
  • Quantitative study reports including biology, pathology, image analysis and biostatistics
  • Executive level tissue report for decision making

Biostatistics
  • Cut-point analysis for IHC and ISH assay development and late stage trials
  • Multivariate analysis of in situ tissue data
  • Formal biostatistics reporting for NDA and IDE submissions

Tissue Image Analysis
  • Pathologist-supervised “fit-for-purpose” image analysis for IND, NDA, and IDE submissions
  • Research or CLIA/GCP endpoints
  • Quantitation of IHC or ISH expression by both tissue and cell localization

Whole Slide Scanning
  • Largest integrated brightfield and fluorescent scanning operation in North America
  • 21 CFR 11 compliant scanning and storage for clinical trials
  • Comprehensive quality control processes for remote reading and digital tissue analysis

Assay Development
  • Immunohistochemistry (IHC) and DNA/RNA in situ hybridization (ISH)
  • Optimization for research and validation for clinical trials
  • Pharma-dedicated CLIA lab for late stage studies

Tissue Procurement
  • Pathologist oversight of commercial tissue sourcing
  • Custom tissue sourcing from US academic partners
  • Creation of custom tissue microarrays

Over 100 biotech, pharmaceutical, and medical device firms rely on Flagship’s tissue analysis to advance emerging therapies into and through regulatory processes. Tissue analysis plays a crucial role in many phases of drug discovery, development, and clinical trials. Flagship is pioneering a novel approach to pathology that combines scientific expertise with digital technologies that are accelerating and refining the entire pathology process to be more precise at every step.

To ensure the quality our customers need when measuring tissue, our team has developed a complete pathology service including tissue sourcing, histology, custom image analysis, biostatistics, and pathology reports.  Projects range from early stage, exploratory, and tissue microarray studies through large, late stage, CLIA-based clinical trials or IDE image analysis companion diagnostics filings. Flagship is platform agnostic on both image analysis and in immunohistochemistry or immunofluorescence, bringing the best solution to the particular client’s tissue challenge. Careful regulatory oversight and quality control have made Flagship a fast-growing leader in the delivery of pharmacodynamic endpoints, biomarker interpretation, and patient selection studies.  We have the personnel and processes to scale projects from early small studies through diagnostic assay development and clinical trial evaluations.