Immunology Center

 

Laboratories with GCP compliance and CAP accreditation
中文 (CN version)


Laboratories with GCP compliance and CAP accreditation

Flow Cytometry Lab

  • Numerous validated cellular biomarkers from peripheral blood and tumors etc.
  • BD FACSCantoII

 

 

Fully Validated Lymphocyte Enumeration Assay by Flow Cytometry

Pathology Lab

  • Validated IHC,DISH and FISH platform
  • HE and pathology evaluation
  • Instruments

· Leica Autostainer XL

· Ventana Benchmark Ultra

· ZEISS-Axio Scan. Z1 Automated scanning

·Zeiss Fluorescent Scope with Z-stack function

·Themobrite

 

HER2- IHC, FISH & DISH fully validated

 

 

 

 

 

 

 

 

PD-L1 Fully Validated on NSCLC

 

Ki-67 Fully Validated on Tonsil and Tumor Tissues

 

 

 

 

 

 

Biomarker Services list

  • Pre-analytical Services

· CDx development, Sample management, etc.

  • Analytical services

· Histopathology, biomarkers, molecular pathology, digitized pathology,  flow cytometry, etc.

  • Project Management
  • Project Setup
  • Investigator Support Services,
  • Lab manual, CRA/CRC training, etc.
  • Clinical Trial lab materials and Logistics support
  • Contract & Proposals

 

Lab Management  

  • LIS, LIMS system and reporting system
  • 3Q for newly-installed equipment and PM for In-use equipment
  • Records & Logbook management and archives
  • Equivalence test for replicate instruments
  • Security Monitoring & Privacy Policy
  • Temperature and humidity monitor
  • Short turnaround time

 

Quality Assurance

  • Internal and external assessment
  • QC and monitoring actions
  • Proficiency Test (2 runs per year)
  • Trained and qualified staffs
  • Project management
  • Data management, transfer and archives