About Us
History
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.
