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美國Asuragen  
Asuragen是一家以RNA治療與診斷為主的綜合性公司，其核心業務是進行miRNA的研究。

Asuragen, based in Austin, Texas, has its roots in Ambion?, “The RNA Company”, a highly successful molecular biology reagent company that was formed in 1989 by Matt Winkler, then a University of Texas professor. With a compounded annual revenue growth rate of 30%, Ambion quickly grew to become the preeminent reagent company focused around RNA. In March 2006, the Senior Management team at Ambion sold the research products division to Applied Biosystems Group, an Applera Corporation business, and formed Asuragen with about 100 employees from Ambion’s Diagnostics and Molecular Biology Services Divisions. Asuragen has exclusive rights to the Ambion patent estate as it pertains to human diagnostics and therapeutics. The goal was to create a strong molecular diagnostics company with a particular emphasis on RNA in general and microRNA (miRNA) in particular. The new company is leveraging its RNA and miRNA expertise into molecular diagnostics, pharmacogenomic services, and therapeutics.

In 1996, Ambion started developing molecular diagnostic capabilities in preparation for a future where it predicted that RNA-based molecular diagnostics would play an increasingly important role in managing disease. Ambion developed Armored RNA?, a technology for producing stable RNA standards for use in diagnostics. Armored RNA? has become the industry standard for infectious disease controls following licensing to the leading molecular diagnostics companies. In 2000, Ambion Diagnostics became a formal division of Ambion. Ambion Diagnostics put in place a cGMP manufacturing facility and staffed the division with the appropriate development, manufacturing, and regulatory employees.

In 2002, Ambion identified the emerging field of miRNAs as an important future research area. Ambion produced research tools for miRNAs that were used by researchers throughout the world. Ambion scientists used these cutting edge technologies to study miRNA expression patterns in a variety of normal and disease samples. It became apparent that miRNAs are both powerful diagnostic analytes and therapeutic entities, akin to siRNAs, which are now being actively developed as therapeutics by companies such as Sirna, Alnylam, ISIS, and others. In 2005, Matt Winkler, Ambion’s founder and CEO, decided to sell Ambion’s research reagent business and focus his efforts on a new company to pursue the substantial opportunities offered by future miRNA-based therapeutics and diagnostics products.

Since its launch, Asuragen has put in place a complete range of capabilities for molecular diagnostics and services, from identifying and validating novel mRNA and miRNA biomarkers to developing and manufacturing new assays under specific regulatory requirements. It is currently housed in a 70,000 square foot facility including 10 cGMP manufacturing suites, 14,000 square foot dedicated to R&D activities, and a state of the art laboratory for molecular services and clinical testing for pharmaceutical and biotechnology customers. The Company is ISO 13485:2003 and 9001:2000 certified, and registered with the U.S. Food and Drug Administration (FDA) as a contract manufacturer and a medical device manufacturer. Asuragen is the only company that offers the full range of contract manufacturing services for high quality RNA and provides GMP contract manufacturing for in vitro synthesized RNA for use in vaccines. It also creates custom Armored RNA constructs for licensees of its Armored RNA technology.

In 2007/2008, Asuragen established its CLIA registered clinical laboratory (CLIA) in Austin and launched the first miRNA-based diagnostic test for distinguishing pancreatic cancer from chronic pancreatitis. In December of 2007 the decision was made to move the miRNA therapeutics activities into a new entity call “Mirna Therapeutics”. Mirna was seeded with $3M from Asuragen and is actively developing miRNA therapeutic entities with oncology applications. For more information on Mirna, see www.mirnarx.com

Together with its current product offerings, a pipeline of innovative products and services, and a broad patent estate covering a variety of technologies and biomarkers, Asuragen is well positioned to leverage its RNA and miRNA expertise into molecular diagnostics and pharmacogenomic services to become a leader in the rapidly growing field of clinical applications for RNA-based technologies. A near-term goal is to introduce additional next generation miRNA-based diagnostic assays to improve tumor classification, monitor disease progression, and potentially allow earlier detection of cancer.