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    Introduction of Reference Laboratory in Korea: Overview of Green Cross Laboratories (GC Labs)

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    Omais
    GC Labs is the largest reference laboratory in Korea, providing diagnostic testing services to over 90% of university hospitals. It has 580 employees including 25 medical doctors across 44 branch offices nationwide. GC Labs processes around 25,000 samples and 75,000 tests per day, with revenues growing from $260 million in 1982 to $85 million in 2015. It has received numerous international accreditations for its quality management and testing services. GC Labs' clinical laboratory sections include quality assurance, various diagnostic testing technologies, pathology, metabolism screening, and central laboratory business including clinical trials and biospecimen services. It also provides bio logistics and overseas healthcare services through strategic partnerships.

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    Introduction of Reference Laboratory in Korea: Overview of Green Cross Laboratories (GC Labs)

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    Omais
    71 views24 pages
    GC Labs is the largest reference laboratory in Korea, providing diagnostic testing services to over 90% of university hospitals. It has 580 employees including 25 medical doctors across 44 branch offices nationwide. GC Labs processes around 25,000 samples and 75,000 tests per day, with revenues growing from $260 million in 1982 to $85 million in 2015. It has received numerous international accreditations for its quality management and testing services. GC Labs' clinical laboratory sections include quality assurance, various diagnostic testing technologies, pathology, metabolism screening, and central laboratory business including clinical trials and biospecimen services. It also provides bio logistics and overseas healthcare services through strategic partnerships.

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    GC Labs is the largest reference laboratory in Korea, providing diagnostic testing services to over 90% of university hospitals. It has 580 employees including 25 medical doctors across 44 branch offices nationwide. GC Labs processes around 25,000 samples and 75,000 tests per day, with revenues growing from $260 million in 1982 to $85 million in 2015. It has received numerous international accreditations for its quality management and testing services. GC Labs' clinical laboratory sections include quality assurance, various diagnostic testing technologies, pathology, metabolism screening, and central laboratory business including clinical trials and biospecimen services. It also provides bio logistics and overseas healthcare services through strategic partnerships.

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    © All Rights Reserved
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    Download as pdf or txt
    71 views24 pages

    Introduction of Reference Laboratory in Korea: Overview of Green Cross Laboratories (GC Labs)

    Uploaded by

    Omais
    GC Labs is the largest reference laboratory in Korea, providing diagnostic testing services to over 90% of university hospitals. It has 580 employees including 25 medical doctors across 44 branch offices nationwide. GC Labs processes around 25,000 samples and 75,000 tests per day, with revenues growing from $260 million in 1982 to $85 million in 2015. It has received numerous international accreditations for its quality management and testing services. GC Labs' clinical laboratory sections include quality assurance, various diagnostic testing technologies, pathology, metabolism screening, and central laboratory business including clinical trials and biospecimen services. It also provides bio logistics and overseas healthcare services through strategic partnerships.

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    of 24

    Introduction of Reference Laboratory in Korea

    Overview of Green Cross Laboratories(GC Labs)

    Jan 24th, 2016

    Saeyun Baik M.D., Ph.D.


    Vice -President
    Head of Central Lab Biz Center & Clinical Trial
    View of Green Cross Town

    GC R&D Center Head Office


    (Mogam Building)

    GC Labs
    (Green Cross Laboratories)

    Research Center
    (Mogam Biotechnology
    Research Institute)
    Green Cross Corporate Structure

    GC Holdings

    Pharmaceutical Healthcare Foundation

    Domestic Overseas GC LabCell


    GC Labs
    GCC GC America GC Genome MOGAM

    GC Medical GC Hong Kong


    Science (GCMS) Holdings GC Healthcare

    GC Cell GC China

    GC Well-being GC Bio Therapeutics  GC Labs : Medical foundation, reference Laboratories, Medical


    testing services
     GC LabCell : NK Cell, Stem Cell, Cord Blood Bank, Clinical Trial
    GC Engineering  GC Genome: Specialized in Genome Analysis
    Maintenance  GCC : Green Cross Corp.
     GC MS : Medical Devices
     GC Cell : Immune Cell Therapy
     MBRI : Mogam Biotechnology Research Institute
     GCEM : Pharmaceutical Engineering maintenance
    View of GC Labs
    History of GC Labs

    1982 Established Green Cross Bio Science Lab by Green Cross

    1986 Renamed Green Cross Reference Lab(GCRL)

    1991 Relocated to Poi-dong facility after re-establishing

    itself as a medical foundation

    1995 First to perform CAP quality control survey

    2004 Expanded diagnostic research facility

    2010 Established Green Cross Lab in Gwangju city(Branch Lab)

    2011 Established GreenCross Labcells (GC Labcell)

    (carries out cell banking & NK cell therapy & Bio Logistics & Clinical trial)

    2012 Renamed as GC Labs

    2013 Established GreenCross Genome(Genomic analysis)

    2014 Established Green Cross Lab in Daegu city(Branch Lab)


    Introduction of Facilities
    Exclusive research facility for clinical test

    · Optimal environment for test


    Double-door, drain control system
    with negative pressure automated air, temperature,
    and humidity system

    · UPS(Uninterruptible power supply)


    365 days, 24 hours

    · Computer Backup System


    Mirroring backup system

    · Security System
    Security system with RF card
    General Information

    ▶ The first reference lab in Korea


    · 580 employees including 25 medical doctors
    · 44 branch offices nationwide ( 2 branch Labs)

    ▶ The largest reference lab with a 30% market share

    90% 25,000 3,000 75,000

    Service to over 90% of samples/day clinical assays tests/day


    university hospitals (22 million per annum)

    ▶ The fastest growing reference lab in Korea


    · Revenue growth from $260 in 1982 to $85 million in 2015
    · International accreditation with world-class laboratory system
    International Accreditations

    ▶ Accreditation from USA


    · CAP (College of American Pathologists), USA
    · CDC (Newborn Screening Quality Assurance Program), USA
    · NGSP (National Glycohemoglobin Standardization Program), USA
    · CDC LSP (Lipid Standardization Program), USA
    · CDC CRMLN (Cholesterol Reference Method Laboratory Network),USA
    · NIST (National Institute of Standards and Technology), USA

    ▶ Accreditation from Europe


    · ISO 9001: 2000 Quality Management System, UKAS, UK
    · ISO 14001: 2004 Environmental Management System, UKAS, UK
    · D-EQAS (VitaminD External Quality Assessment Scheme), UK
    · German External Quality Assessment Scheme, Germany
    International Accreditations

    Accreditation contents Certificates

     The College of American Pathologists


     PT (Proficiency Test) since 1995
     25 section in 2015
     580 items on CAP PT in 2015
     Accuracy based survey:
    ABL(lipid), ABVD, LN24(creatinine),
    CAP, USA
    LN15, GH2, CFS

    Items(Code ) Number

    Product code - Total 117

    LN(Calibration verification) 12

    Accuracy 7
    International Accreditations

    Accreditation contents Certificates

    Quality
    Management  2008.7.
    System
     Scope: Provision of clinical test services
    ISO 9001/2008

    Environment  2008. 7.
    Management
    System  For the 1st time in Korea (healthcare area)
     Scope: Provision of clinical test services
    ISO 14001/2004
    Clinical Laboratory Sections

    1. Quality Assurance

    2. Laboratory Medicine

    · Automation & Robotics


    · Microbiology
    · Hematology
    · Immunology – EIA, RIA
    · Infection Genomics
    · Human Genomics
    · Cytogenetics

     The molecular tests for infectious diseases, cancers and rare disease
    diagnosis, personal identification test and chromosome analysis

     Recent technologies: capillary sequencing, pyrosequencing, lumix


    technology, microarray, MALDI-TOF
    Clinical Laboratory Sections

    3. Pathology
    Conclusive pathological diagnosis through microscopic and special pathology testings

    4. Institute of Metabolism

    · Extensive screening test on newborn baby for inborn error metabolic disease
    · Metabolite analysis including functional medicine tests
     Organic acids, Amino acids, Hair elements, Toxic & Nutrient elements, vitamins
    · Detection of trace metal, Enzyme assay
    · Pharmaco-kinetic (PK) tests

     LC-MS/MS, GC-MS, HPLC, IC, ICP-MS


    functional medicine tests
    functional medicine tests
    Clinical Laboratory Sections

    5. Central Lab Biz Center

    · Biospecimen Processing Team & Biobank system


    · Clinical Trial Lab team, central Laboratory business

     Operated by highly trained experts, collaborating with CRO's in Korea, and overseas

     Contract : Consultation → Quotation Drafted → Contract Closed

     Analysis : Quality Control → Specimen Analysis → Confirmation → Results Report

     Post-Management : Validating Data Provided → Specimen Storage / Disposal → Case

    File Archived

     Samples from other countries

     Japan, USA, Taiwan, Vietnam, Australia, Philippines, Malaysia


    Clinical Laboratory Sections Business scope

    Research
    Organization

    Korean CDC & KFDA

    Domestic

    Government
    GC Labs Clinical Trial

    Related
    Central Laboratory

    Multinational
    (Global)
    Clinical Trial
    Bio Logistics Service solutions

    • Refrigerated box
    • Smart Tag
    • Ambient (Room temperature) box
    • Temperature, Vibration, GPS
    • Frozen box

    • IoT sensor reader (RFID) • 900 Mhz


    • Operation Temp: -40~70℃
    Overseas Healthcare Service

    Type of
    Shipment
    Vaccines Cell Diagnostic Medical
    Drugs Kits Biologicals Cultures Cord Blood Specimens Devices

    Temperature Ambient Refrigerated Frozen


    Requirement (+1 ~ +30 ℃) (+2 ~ + 8℃) ( - 20 ~ -190 ℃ )

    Geography
    Within Asia International
    Coverage
    Korea

    TransitTime Within Korea Asia International

    Sameday Nextday 24hr 48hr 72hr

    Service STANDARD EXCLUSIVE


    Levels
    Green Cross Genome : Summary
     Established in August 2013
     As a affiliated company of Green Cross in the field of genome analysis, we
    provide disease diagnosis services, such as prenatal genetic test, oncogenomic
    analysis and personal drug reaction prediction.
     With introduction of next-generation DNA sequencer and large capacity gene
    analytic equipment, we will strive to realize personalized medical services by
    the diagnostics development and disease-oriented genome studies.
    Green Cross Genome : Business Portfolio
    Predictive
    * Prenatal Diagnosis
    - Fragile X
    - Myotonic Dystrophy
    Overseas - AR Mendelian Disorder
    Preventive
    - NIPT
    Business * Health Check
    - Cancer Susceptibility
    - Exports - Pharmacogenomics
    - Business Alliance - Immune Function Test
    - Genetic Disease Screen

    Genome Research
    Research Center Personalized
    Project * Patients
    - Governmental Project - Autism, MCA
    - Joint Study with - Hematologic Disorder
    External Institutes - Solid Tumor
    Microbiome
    - Metagenomics
    - Microbial Drug
    Susceptibility Test
    Breast Ca, Ovarian Ca, Thyroid Ca, Colon Ca, Stomach Ca 예측
    Green Cross Genome
    Non-Invasive Prenatal Test
    Non-Invasive Prenatal Test is a sophisticated blood test that examines fetal DNA in the maternal
    bloodstream to determine whether your baby is at risk of Down syndrome (trisomy 21), extra sequences of
    chromosome 13 (trisomy 13), extra sequences of chromosome 18 (trisomy 18) or a sex chromosome
    abnormality, such as Turner syndrome. the option of noninvasive fetal aneuploidy screening.

    01 02 03 04
    Fast Accurate Safe Trusty

    G-score

    • TAT 7 days • Increased depth • Non-invasive • The largest number


    • Optimized, self- • Potentially less of positive samples
    developed analysis amniocentesis rate • Interpretation by
    solution medical doctors
    • Competitive and
    Affordable price
    Green Cross invites you to our booth
    Zaa’beel Hall, Z4 G29
    25th ~ 28th Januaury, 2016

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