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Rosetta Genomics is Issued Another Patent Relating to MicroRNAs


Tuesday, July 31, 2007

Rehovot, Israel and New York, NY -- Rosetta Genomics, Ltd. (Nasdaq: ROSG), a global leader in the field of microRNA and RNAi, announced that on July 31, 2007, the United States Patent and Trademark Office (USPTO) issued Rosetta Genomics U.S. Patent No. 7,250,496. The patent, relating to a human microRNA miR-492, is the second composition-of-matter patent that the USPTO has issued to Rosetta Genomics but is the first patent issued to it related to a human microRNA. The first microRNA gene patent ever issued worldwide was issued to Rosetta Genomics by the USPTO in May 2007 for a viral microRNA.

This recent patent issuance is part of Rosetta Genomics overall Intellectual Property (IP) strategy. This strategy is designed toestablish a broad and integrated IP Portfolio upon which the company is building its microRNA-based diagnostic and therapeutic discovery engines. The portfolio covers broadly both human and viral microRNAs and consists of three main efforts:

  • Protect all microRNA sequences and microRNA targets - Rosetta Genomics has filed patent applications covering all potential applications relating to a specific sequence. These include the microRNA pre-cursor, the specific microRNA sequence, and the predicted target of the microRNA.
  • Protect uses of microRNA sequences and targets for development of diagnostics and therapeutics - Rosetta Genomics has filed patent applications covering the use of microRNAs as diagnostic biomarkers and therapeutic targets. These applications are based on research conducted by the company demonstrating the potential of microRNAs as both biomarkers and drug targets.
  • Protect enabling technologies necessary for the extraction, identification and quantification of microRNAs - Rosetta Genomics has filed patent applications covering its proprietary technologies which allow for the extraction, identification and quantification of microRNA. Included in these applications are microRNA extraction protocols for various body fluids such as serum, saliva, urine and amniotic fluid; tissue samples including fresh/frozen, and Formalin Fixed Paraffin Embedded (FFPE), as well as highly specific and sensitive microarray and qRT-PCR technologies.

"We believe this most recent patent issuance, further validates our leading intellectual property estate," said Amir Avniel Rosetta Genomics' CEO, "Since 2002, we have been systematically filing patent applications intended to broadly protect our ability to develop cutting-edge microRNA-based diagnostics and therapeutics. We expect to see additional patents issue in the coming months and years, placing Rosetta Genomics at the forefront of the microRNA and RNAi diagnostic and therapeutic sectors."

In 2002, Rosetta Genomics began extensive patent application filings in the emerging area of microRNAs and RNAi. Based on a proprietary bioinformatics platform, the company filed patent applications on short RNA sequences, the precursor forms of those sequences and the messenger RNA targets of those sequences. These extensive composition-of-matter patent applications have been followed by patent application filings on specific uses of those sequences for diagnostic and therapeutic purposes. Finally, in conducting the research to support these filings, the company developed novel extraction, identification and quantitative technologies for which the company has subsequently filed for patent protection. In addition to the two recently issued patents, Rosetta Genomics currently has filed over 60 patents and has approximately 20 patents applications under active examination.

About RNAi and MicroRNAs

RNAi (RNA interference) is the means by which plants, animals and humans regulate protein expression and represents a potentially revolutionary approach to the development of human diagnostics and therapeutics. The discovery of RNAi in 1998 and the subsequent awarding of the Nobel Prize to Drs Fire and Mello in October 2006, attest to the broad and rapid advancement of our understanding of this key biological process and to statements within the scientific community referring to it as "a major scientific breakthrough that happens once every decade or so." RNAi is a natural process of gene silencing that is mediated by microRNAs intracellularly. By targeting microRNAs, we believe there is significant potential to create a new class of therapeutics that can both up and down-regulate disease causing proteins. Since microRNAs are naturally produced inhibitors of protein production, a synthetic molecule designed to mimic the activity of a microRNA can potentially cause RNAi to decrease protein production while a microRNA inhibitor may have the potential to prevent RNAi from silencing specific messenger RNA, thereby increasing protein production. This up and down regulation of the RNAi process can potentially prevent disease causing proteins from being produced in too much or too little a quantity. Moreover, microRNAs that regulate disease causing proteins may be used as biomarkers for the disease, potentially enabling the use of the RNAi process to develop early detection diagnostics.

About Rosetta Genomics

Rosetta Genomics (Nasdaq: ROSG) is a leader in the development of microRNA-based diagnostics and therapeutics. Founded in 2000, the company's integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong IP position and strategic alliances with leading biotechnology companies, Rosetta Genomics is working to develop a full range of diagnostic and therapeutic products based on microRNAs. The company's primary focus is in the development of microRNA-based products to diagnose and treat different forms of cancer and infectious diseases.

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, statements relating to the role of miRNAs in human physiology and disease, the potential of microRNAs in the diagnosis and treatment of disease, and the expectation that additional patents will issue in the future constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: Rosetta's approach to discover and develop novel diagnostics products, which is unproven and may never lead to marketable products; Rosetta's ability to fund and the results of further pre-clinical and clinical trials; Rosetta's ability to obtain, maintain and protect the intellectual property utilized by its products; Rosetta's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta's ability to obtain additional funding to support its business activities; Rosetta's dependence on third parties for development, manufacture, marketing, sales, and distribution of products; the successful development of Rosetta's product candidates, all of which are in early stages of development; obtaining regulatory approval for products; competition from others using technology similar to Rosetta's and others developing products for similar uses; Rosetta's dependence on collaborators; and Rosetta's short operating history; as well as those risks more fully discussed under "Key Information - Risk Factors" in the company's Annual Report on Form 20-F for the year ended December 31, 2006 on file with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta's views only as of today and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.



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