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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 Business Contact North America: Declan Ryan, declan.ryan@wuxiapptec.com Europe and Israel: Dave Madge, dave_madge@wuxiapptec.com China: Marcher Xu, xu_longji@wuxiapptec.com Japan: Yan Zhu, yan_zhu@wuxiapptec.com Korea: Suk Young Cho, sycho@wuxiapptec.com