Asuragen is a molecular diagnostics company using genomics to drive better patient management through best-in-class clinical testing solutions. With a pioneering position in miRNA, Asuragen has assembled cutting edge technologies to discover, develop and commercialize diagnostic products and clinical testing services. Our experienced team utilizes these capabilities to operate with efficiency and flexibility with our internal R&D programs as well as with our companion diagnostic partners. Building on the Company’s heritage, Asuragen has developed a reputation as a world class molecular diagnostics Company and has created a culture driven by nimble, innovative and determined teams of scientists and professionals inspired to improve patient management through molecular diagnostics.
A carve-out of Ambion, Asuragen continues a legacy of leadership in the molecular diagnostics arena with a proprietary position in the application of miRNA technology for diagnostics. Today, Asuragen’s products, services and technologies drive countless patient management decisions across oncology, genetic disease and other molecular testing modalities. In the future, we envision the Company’s development of miRNA-based clinical diagnostics will help transform medicine by improving clinical outcomes and health economics.
Built for Companion Diagnostics
By harnessing the discovery, development and diagnostic capabilities across the Company’s three business units (Genomic Services, CLIA Laboratory Services and Diagnostic Products), Asuragen brings to our partners a seamless development process for companion diagnostics. With a deep understanding of the drug development process matched with proven molecular diagnostic capabilities, Asuragen is able to shorten the companion diagnostics development cycle and reduce costs while improving the likelihood of regulatory approval for our partners.
Discovering Novel Molecular Signatures
Our scientific team has discovered molecular signatures that have translated to first-in-class products that provide solutions for unaddressed challenges in clinical practice. Made possible through world-renowned science, Asuragen has become a proven force in molecular biology by discovering new biomarkers and diagnostics products for our partners as well as our own internal pipeline. As pioneers in the application of miRNA technology, Asuragen developed a pancreatic cancer test that is the world’s first miRNA-based diagnostic test.
Diagnosing Disease and Improving Patient Management
Asuragen’s products and technologies guide more than 15 million medical decisions for patients each year and our oncology and genetic disease assays are used by more than half of the NCI Centers of Excellence. From monitoring the effectiveness of leukemia treatment to informing reproductive decisions to optimizing surgical approaches in thyroid cancer, Asuragen brings diagnostics to market to improve patient care and personalize treatments. In addition, our market-leading test for Fragile X has radically changed the way FMR1 gene mutations are detected.
Developing Testing Solutions for Today’s Clinical Challenges
Asuragen is one of the few molecular diagnostics companies capable of spanning the diagnostic development spectrum from biomarker discovery and clinical validation to manufacturing and global commercialization. Our genomic services group has translated over 40 assay development projects into analytically and clinically validated tests for pharmaceutical partners. We have the flexibility and know-how to develop tests on the most appropriate diagnostic platform — our tests run on 12 of the leading molecular platforms available worldwide. Fifteen of the top 20 Bio/Pharma companies have partnered with us to accelerate their drug development programs.
Our recently launched SuraSeq™ service brings next generation sequencing (NGS) into the clinical setting and represents the power of our diagnostic genomic capabilities. Pre-built and custom-designed panels are optimized for FFPE and FNA on multiple NGS platforms for our Pharma customers.
|2009||Asuragen spins off Mirna Therapeutics to actively develop miRNA-based therapies for cancer. For more information on Mirna, see www.mirnarx.com.|
|2006||Asuragen launches based in a 70,000 square foot facility in Austin, Texas 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 CLIA 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.|
|2006||Ambion sold the research products division to Applied Biosystems Group (Now LIFE Technologies) and formed Asuragen with about 100 employees from Ambion’s Diagnostics and Molecular Biology Services Divisions.|
|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.|
|1996||Ambion began 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.|
|1989||Ambion®, “The RNA Company”, a highly successful molecular biology reagent company was formed in 1989 by Matt Winkler, then a University of Texas professor.|