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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.
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.
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