Clinical Biomarker

Clinical Biomarker Service Overview


  • Clinical biomarker services by pathology and flow-cytometry
  • CAP accreditation and GCP compliance for clinical trials
  • Technology platforms:
  •          a) Anatomic pathology: H&E, IHC, IF et al.
  •          b) Molecular pathology: FISH & RNA ISH et al.
  •          c) FACS capability



Flow Cytometry Lab


  • Numerous validated cellular biomarkers from peripheral blood and tumors etc.
  • Cell activation & differentiation markers
  • Cytokine & chemokine receptor analysis
  • Signaling pathways



Pathology Lab


  • Validated IHC and FISH platform
  • Anatomic pathology, H&E and histologic evaluation



Test Menu


  • Anatomic pathology: H&E staining, Neoplastic Cellularity
  • IHC: HER2, ER, PgR, EGFR, c-MET, PD-L1, Ki-67, MMR, etc.
  • FISH: HER2, EGFR, MET, ALK, etc.
  • FACS: T/B/NK cell enumeration
  • Other customized biomarker detection



Biomarker Services List


  • CDx development, assay validation
  • Sample management, from collection to archive
  • Data management: LIMS, reporting system, raw data backup and storage
  • Project Setup: Launch verification, SOP generation, site initiation visit, pilot study and site training
  • Analytical service: Study operation, issue escalation, progress updates, metrics and monitoring actions
  • Study close-out: Raw data transfer and archival, study records transfer and archival, samples transfer and archival, study close out visit
  • Investigator support services: Lab manual, CRA/CRC training, etc.
  • Clinical trial lab materials and logistics support
  • Contract & Proposals



Lab Management  


  • LIMS 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



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



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