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China Molecular Diagnostics
General Biologic, May 2008, Pages: 80
I Background
History
- Polymerase chain reaction
- Biochips
- Other molecular diagnostic technologies
Applications
Government & policies
Marketing
II History of China molecular diagnostics
Nucleic acid hybridization
Polymerase chain reaction (PCR)
- End of the party
Quantitative nucleic acid analysis
Biochip technologies
Entry of multinational companies
III PCR technologies
PCR diagnostic reagent kits
PCR instruments
Instruments from the multinationals
Domestic instruments
PCR Fluorescent end-point detectors
PCR thermal cyclers and Real-Time PCR Systems
IV Biochips
There are many biochip companies and most of them are small
Complex ownership structures
Few clinical products
Quality problems for clinical use
Few MNC products have entered clinical labs
Approved biochip products
V Other molecular diagnostics
Automated nucleic acid extraction
VI Key molecular markets & indicators
Hepatitis B
Hepatitis C
Tuberculosis
HIV/AIDS
Chlamydia trachomatis (CT)
Human papilloma virus (HPV)
Thalassemia
VII Government & policy environment
Relevant government departments
- Ministry of Health of the People's Republic of China (MOH)
- State food and Drug Administration (SFDA)
- National Institute for the Control of Pharmaceutical and Biological Products(NICPBP)
- National Center for Clinical Laboratories (NCCL)
- Medical Subcommittee #4 of the Technical Committee of The China NationalAccreditation Board for Laboratories (CNAL/TC/SC4)
- Chinese Association of Clinical Laboratory Management (CACLM)
- Chinese Society of Laboratory Medicine (CSLM)
- Chinese Committee for Clinical Laboratory Standards (CCCLS)
Administration of molecular diagnostics
- Administration of manufacturers
- Administration and registrations for molecular diagnostics
- Administration of the distribution of molecular diagnostics
- MOH directives for the administration of clinical medical institutions
Quality management for clinical laboratories
- Quality Assurance
- Laboratory Accreditation
- Pricing
VIII Market
Market size
Buyer segments
- The accreditation of medical institutions in China
Kit and device sales strategies
Pricing
Distribution channels
Trends
- The market for molecular diagnostics will grow
- Molecular diagnostics will face short term difficulties
- Government policies will have a strong influence
- Growth, decreasing numbers of players, M&A activity
- Direct sales will become the leading sales strategy
IX Profiles
Da An Gene Co Ltd of Sun Yat-Sen University
- Introduction
- Company structure
- Main products on market
- Strengths and weaknesses
Shenzhen Yishengtang Biological Products Co Ltd
- Introduction
- Company structure
- Main products on market
- Strengths and weaknesses
United Gene Holdings
- Introduction
- Main subsidiaries
- Main products on market
- Strengths and weaknesses
Shenzhen PG Biotech Co Ltd
- Introduction
- Company structure
- Main products on market
- Strengths and weaknesses
X Appendix
References
Abbreviations
Interim Regulation for Clinical Gene Amplification Laboratories
Basic Installation Standards for Clinical Gene Amplification Laboratories
Key points of MOH regulations for the administration of clinical laboratories in China
lmportant laws, regulations, and provisions
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