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Asuragen Announces New Notices of Allowance from USPTO Related to the Diagnostic Applications of Cancer-Related miRNAs at the JP Morgan Healthcare Conference

Wednesday, January 12, 2011

Austin, TX -- Asuragen, Inc., a leader in the development of molecular diagnostics, announced today at the 29th Annual JP Morgan Healthcare Conference in San Francisco that it had received Notices of Allowance from the United States Patent and Trademark Office (“USPTO”) for claims related to the use of mir-21 and mir-30a as diagnostics in lung cancer. Human miR-21 has been identified as being highly expressed in lung cancer when compared with its expression in normal lung tissue, and, as a result, may be an excellent marker for use as a diagnostic for lung cancer. Asuragen plans to launch its first miRNA kit, a miR-21 (RUO)* kit for the detection of mir-21 expression levels, in the second quarter of this year. Asuragen has a broad IP portfolio with over 69 allowed and pending patents related to miRNA including some of the earliest functional diagnostic applications for a number of key miRNAs associated with oncology diseases.

miR-21 has been implicated as a possible therapeutic target and in several clinically relevant diagnostic applications, including potential improvements in early detection and more informed prognosis of lung cancer. Aberrant miR-21 expression has been associated with the misregulation of key mediators of cell signaling circuits in well-established cancer pathways. miR-21 has been identified as a key regulator of PTEN which is associated with resistance to Herceptin® therapy in breast cancer.

“Asuragen has been a pioneer in the development of miRNAs as diagnostic tools in cancer. We were the first company to launch a clinically validated miRNA-based diagnostic test and now are poised to launch our first miRNA-based detection kit. miRNAs are a category of biomarkers whose importance is increasingly being recognized,” said Matt Winkler, CEO and CSO of Asuragen. “We are beginning to see a steady stream of allowances from our early miRNA patent filings which highlight our early pioneering work in the development of microRNA technologies for health care applications.”

About microRNA

miRNAs are approximately 21 nucleotides long and affect gene expression by interacting with messenger RNAs. Unlike siRNAs, miRNAs are encoded in the human genome and are natural regulators of global gene expression. More than 900 miRNAs are encoded in the human genome and comprise approximately 2% of all mammalian genes. Since each miRNA appears to regulate the expression of tens to hundreds of different genes, miRNAs can function as “master-switches,” regulating and coordinating multiple cellular pathways and processes. By coordinating the expression of multiple genes, miRNAs are responsible for guiding proper embryonic development, and regulating processes involved in immunity, inflammation, as well as cellular growth and proliferation. Misregulation of miRNAs appears to play a fundamental role in many cancers and unique microRNA profiles have been identified that are useful for diagnosis of certain cancer types.

About Asuragen

Asuragen is a fully integrated diagnostic development company and pharmaceutical services provider. The Company’s diagnostic product portfolio consists of the first-ever validated microRNA diagnostic assay for pancreatic cancer, quantitative RNA tests for leukemia gene translocations, innovative genetic testing solutions for the fragile X mental retardation (FMR1) gene, Signature® Oncology products for the qualitative detection of gene translocations and mutations in a variety of hematological and solid tumors, RNA stabilization technologies, and industry-leading controls and standards engineered using its patented Armored RNA® technology. Asuragen is empowered with a high level of scientific expertise and assay development capabilities, CLIA and GLP testing services, and an established cGMP manufacturing facility, which allow it to span the spectrum of discovery, testing, production and commercialization. For more information, visit

*For Research Use Only. Not For Use in Diagnostic Procedures.

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