PhenoPath’s BioPharma provides analytic and diagnostic services to our clients through its team of pathologists, scientists, operations specialists, and data experts. PhenoPath has over 15 years of research experience with pharmaceutical, biotechnology and academic institutions worldwide working on pre-clinical research, biomarker discovery, drug development, assay development, and Phase I-III clinical trials. Each stage of your project is supported by a team of project managers, laboratory personnel, scientists, and board-certified pathologists.

• Comprehensive Diagnostic Oncology Experience

  • We are nationally recognized leaders in solid tumor and hematologic cancer diagnostics
  • PhenoPath pathologists have diagnosed and identified targeted therapy on over 200,000 clinical cases and supported over 3,200 clinical research projects

• Extensive Method Development

  • Our scientific team has extensive experience in the development, validation/verification and use of laboratory developed tests (LDTs), analyte specific reagents (ASR), in vitro diagnostic (IVD) tests, and research use only (RUO) tests
  • Test disciplines include Immunohistochemistry (IHC), DNA/RNA in situ hybridization (ISH), flow cytometry, Polymerase Chain Reactions (PCR), Flourescence ISH (FISH), Immunofluorescence (IF), and cytogenetics
  • Over 450 tests are offered in support of our medical practice and research customers

• Academically Driven Pathology Team

  • PhenoPath actively participates in guiding the future of diagnostic pathology through clinical research and academic appointments
  • Our pathologists are published in diagnostic cancer studies (collectively over 450 scientific publications) and hold leadership appointments on national consensus and guideline committees (e.g., CAP, USCAP, Int’l Clinical Cytometry Society, and AMP)
  • Customer education and collaboration are core commitments

• Quality Driven Processes

  • Standardization of methods, automation and quality control ensures reproducible and accurate results
  • Our comprehensive quality system is built upon Standard Operating Procedures (SOPs), regulatory training, job specific competency assessments, and process controls
  • Each project is tailored to the client's needs and expectations for testing methods, quality standards, and documentation 

• Expert Pathology Support

  DIAGNOSIS & INTERPRETATION

  • Diagnosis and subtyping of solid tumors and hematolymphoid neoplasms
  • Tissue biomarker quantification capabilities for applicable assays
  • Histology support including processing, embedding, sectioning, and staining and analysis
  • Tissue macrodissection for downstream assays

   

  THERAPEUTIC AREAS OF FOCUS

  • Oncology • Solid Tumor • Hematology • Immuno-Oncology • Dermatology 

   

  EXPERT CONSULTATION

  • Consultation on choosing therapeutic targets
  • Central pathology lab for diagnosis confirmation/enrollment eligibility on clinical trials
  • Second opinion consultation on complex cases including clinical and diagnostic correlation 

   

  CONTINUOUS EDUCATION

  • PhenoPath pathologists follow the latest developments in diagnostic oncology
  • PhenoPath pathologists publish extensively in peer-reviewed scientific journals
  • PhenoPath's Pathology Reference Guide available 

• Analytic Capability

  IHC/ISH	FLOW CYTOMETRY	MOLECULAR	FISH / CYTOGENETICS	METHOD DEVELOPMENT
  IHC	10 Color (3-laser)	Digital PCR	FISH - morphometric analysis	Feasibility studies
  DNA/RNA ISH (RNAScope)	Rare cell analysis	RT - PCR	Copy number analysis	Optimization and validation
  Immuno- fluorescence	Minimal residual disease	qPCR	Karyotyping	CAP based validation
  Special stains	Hematolymphoid immunophenotyping	Sequencing		Extensive validated test library
  Image analysis and e-pathology		Gene expression profiling

• Project Delivery

  PROJECT MANAGEMENT

  • Central point of contact for all project activities
  • Structured process that ensures project success
  • Metrics-driven performance management
  • Cross-functional coordination of all service delivery groups within PhenoPath

   

  DATA MANAGEMENT

  • Customized database incorporating validated tracking, results reporting, and quality assurance
  • Scalable and configurable results-reporting database
  • Virtual pathology reporting capabilities
  • Secure and encrypted data transfer and archiving

   

  GLOBAL LOGISTICS

  • Established international and domestic shipping capabilities
  • Sample integrity and security based on GCP & GLP protocols
  • Dedicated lab data management system for sample tracking & clinical reporting management
  • Long-term sample storage including DNA/RNA samples, tissue blocks, and slides, with full tracking 

BioPharma Services (Flyer)