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      Molecular diagnostics is the leading growing segment within the in vitro diagnostics (IVD) market. The anticipated annual growth rate of molecular diagnostics segment is 11% to 12 % in developed countries, and 18% to 20% in emerging countries. The projected global IVD market is up to US$6 billion in 2014.

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      MBC has established the Nucleic Acid Testing (NAT) technology platform since 2005. Facilitated by the in-house molecular diagnostic technologies, MBC launched its first benchmark HLA kits (Morgan™ HLA SSP Typing Kits) to the global market in 2007 through an efficient vertical integration of product design, development, manufacturing, clinical studies, certification and marketing. This technology platform serves as the core for future expansion of products in the field of NAT pathogen detection kits, and for further integration of fully automated workstation machinery with MBC's NAT kits.

      MBC's NAT business strategy is to establish partnerships through M&A to leverage upstream novel NAT technologies to downstream manufacturing and marketing of state-of-the-art molecular diagnostic products. Two major steps were taken by MBC in order to play a pivotal role in NAT field.

      Firstly, in 2004, MBC acquired Texas BioGene Inc.(TBG), an US based company, which specialized in diagnostic kits for Human Leukocyte Antigen (HLA). Currently, MBC’s Morgan™ HLA SSP Typing Kits, have been approved by DOH Taiwan, FDA 510k, and CE mark, allowing MBC the freedom to sell to the international market. Up to this date, MBC has been selling HLA products to 22 countries including USA, Mexico, Brazil, Germany, France, Italy, Portugal, Turkey, Iran, India, Indonesia, Vietnam, Malaysia, Singapore, Taiwan and China via well-established distribution channels. Besides international distribution networks, MBC has been devoted to the HLA typing service to meet local needs for organ and bone marrow transplantations. MBC received laboratory accreditation by ASHI (American Society for Histocompatibility and Immunogenetics) in 2009 and will continue to provide quality NAT and HLA analysis services in a cost-effective manner for clinical applications.

      Secondly, in 2008 MBC acquired Shanghai Haoyuan Biotech Co., Ltd which has SFDA certified GMP production facility with 50 employees. Having acquired Shanghai Haoyuan Biotech Co., Ltd enables MBC to target the blood screening market for HIV/HBV/HCV testing conducted in nation-wide blood banks in China. With superior R&D capability, Haoyuan Biotech has launched a proprietary 5-channel, 3 in 1 screening kit (qualitative q-PCR kit for HIV/HBV/HCV within one test) which is expected to be approved by the SFDA by Aug 2011. With the launch of this cutting-edge product, Haoyuan Biotech is aiming at a market penetration of up to 25% of blood banks and blood products manufacturers in China in 3 years. In addition, Haoyuan Biotech also received several SFDA certificates for quantitative NAT kits designated for clinical diagnosis and detection of HIV, HBV, HCV and CT/GC. The blood screening market in China is expanding in line with the implementation of China’s 5-year National Medical Reform Plans (2010~2015) aiming to lift public medical/health services to a higher horizon. This Reform offers Haoyuan Biotech a great business opportunity to substantially increase revenue that will be beneficial to both Haoyuan Biotech and MBC.

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      The products portfolio from this NAT platform is expected to expand to cover a range of pathogen detection, hereditary diseases detection and other clinical uses. With the current GMP facilities and business operation in China, MBC is aiming to become a major player for NAT diagnostic, not only in China, but also in other Asian-pacific countries in the near future.