Medigen’s strategy for developing Nuclear Acid Testing (NAT) products is via global merger and acquisition (M&A). In 2004, Medigen acquiredTexas BioGene Inc.(TBG), a United States company that develops NAT for organ and bone marrow transplantation and Shanghai Haoyuan Biotech Co., Ltd., in 2007. Haoyuan is a provider of nucleic acid-based blood screening solutions for the blood banking and clinical diagnostics to market in China.
As a global molecular diagnostics company, Medigen vertically integrated its ability to design, develop, and manufacture in order to acquire international IVD certifications. As a result, Texas BioGene NAT products are certified by the Taiwan Department of Health, 510(k) approved by the US FDA and CE-IVD marked by the European Union. Based on these approvals, product distribution now covers over 20 countries including United States, Germany, France, Italy, India, Malaysia, Singapore, China and Taiwan.
Furthermore, strategic alliance was formed with Perkin Elmer in Nov. 2012 through the sale of Shanghai Haoyuan Biotech equity stakes for $38.0 million in cash.
As the wait-list of transplant recipients continues to grow worldwide, TBG recently developed an ultra-high resolution DNA sequencing reagent to prolong the lifespan of each precious transplant. By using a full coverage “Group Specific Amplification” (GSA) DNA sequencing design, we can now investigate regions of our DNA that can be used to reduce the rate of transplant rejection.
To take advantage of Taiwan’s strength in electronics, TBG developed one of the first “SMART” Automation System for transplant IVD products. Not only will this automation system reduce human errors, the patent pending “SMART Processing” control software can provide the most efficient method to reach an ultra-high DNA typing resolution.
TBG (Xiamen) Corp. was established in January 2014 with location in China’s Xiamen Haicang Bio Bay. It has a 6500 square meter plant with state of the art facility capable of large scale manufacturing dedicating to the development, manufacture and marketing of IVD related nucleic acid testing kits and services.
Building on its core technologies, TBG has been pushing to the forefront of nucleic acid testing for diagnostics in pathogens, personalized medicine and genetic diseases, as well as providing third-party testing services.