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