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
Research Center
(Mogam Biotechnology Research Institute)
GC R&D Center Head Office
(Mogam Building)
GC Labs
(Green Cross Laboratories)
Green Cross Corporate Structure
Healthcare
GCC
GC Medical Science (GCMS)
GC Well-being
GC Hong Kong Holdings
Domestic Overseas
GC America
GC Cell
GC Holdings
GC China
Pharmaceutical
Foundation
GC Labs
GC Engineering Maintenance
MOGAM
GC Healthcare
GC LabCell GC Genome
GC Labs : Medical foundation, reference Laboratories, Medical testing services
GC LabCell : NK Cell, Stem Cell, Cord Blood Bank, Clinical Trial
GC Genome: Specialized in Genome Analysis
GCC : Green Cross Corp.
GC MS : Medical Devices
GC Cell : Immune Cell Therapy
MBRI : Mogam Biotechnology Research Institute
GCEM : Pharmaceutical Engineering maintenance
GC Bio Therapeutics
View 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 foundation1995 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)
History of GC Labs
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%
Service to over 90% of university hospitals
25,000
3,000
samples/day clinical assays
75,000
tests/day (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
CAP, USA
contents
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), LN15, GH2, CFS
Certificates
Items(Code ) Number
Product code - Total 117
LN(Calibration verification) 12
Accuracy 7
International Accreditations
Accreditation
Quality
Management System ISO 9001/2008
contents
2008.7.
Scope: Provision of clinical test services
Certificates
Environment Management System
ISO 14001/2004
2008. 7.
For the 1st time in Korea (healthcare area)
Scope: Provision of clinical test services
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
GC Labs
Central Laboratory
Domestic Clinical Trial Research
Organization
Multinational (Global) Clinical Trial Government
Related
Korean CDC & KFDA
Bio Logistics Service solutions
• Refrigerated box
• Ambient (Room temperature) box
• Frozen box
• IoT sensor reader (RFID) • 900 Mhz
• Operation Temp: -40~70℃
• Smart Tag
• Temperature, Vibration, GPS
Overseas Healthcare Service
Type of Shipment
Temperature Requirement
Geography Coverage
TransitTime
Service Levels
Drugs Kits
Medical Devices Vaccines
Biologicals
Cell
Cultures Cord Blood
Diagnostic Specimens
Ambient (+1 ~ +30 ℃)
Refrigerated (+2 ~ + 8℃)
Frozen ( - 20 ~ -190 ℃ )
Within Korea
International Asia
Sameday Nextday 24hr 48hr 72hr
Within Korea Asia International
STANDARD EXCLUSIVE
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
Research Project
- Metagenomics - Microbial Drug Susceptibility Test - Governmental Project
- Joint Study with External Institutes
Genome Research Center
- Exports
- Business Alliance
Predictive
* Prenatal Diagnosis - Fragile X
- Myotonic Dystrophy - AR Mendelian Disorder
- NIPT
Preventive
Personalized
Microbiome Overseas
Business
* Health Check- Cancer Susceptibility - Pharmacogenomics - Immune Function Test - Genetic Disease Screen
* Patients - Autism, MCA
- Hematologic Disorder - Solid Tumor
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.
Fast Accurate Safe Trusty
01 02 03 04
• TAT 7 days • Increased depth
• Optimized, self- developed analysis solution
• Non-invasive
• Potentially less amniocentesis rate
G-score
• The largest number of positive samples
• Interpretation by medical doctors
• Competitive and Affordable price
