REHOVOT, Israel and JERSEY CITY, New Jersey and PHILADELPHIA, December22 Rosetta Genomics, Ltd. (NASDQ: ROSG), a leadingdeveloper of microRNA-based molecular diagnostics, announced today thecommercial availability of its second diagnostic test, miRview(TM) mets. Thetest is now commercially available through Rosetta Genomics CLIA-certifiedlab in Philadelphia.
The test identifies 25 different tumor types, including, but not limitedto, those from the following tissue origins: colon, brain, breast, kidney,liver, lung, ovary, pancreas, prostate, and testis. The test leveragesproprietary microRNA technology developed by Rosetta Genomics, and measuresthe expression level of 48 microRNA biomarkers in the tumor.
To order the test, physicians may contact 1-888-522-7971, or visit thecompany's website http://www.rosettagenomics.com.
This is Rosetta Genomics' second commercially available microRNA-basedtest, following the introduction of miRview(TM) squamous last week. Thecompany expects miRview(TM) meso, a test differentiating mesothelioma fromadenocarcinoma in the lung, to soon be commercially available.
By the end of 2008, Rosetta Genomics expects to be able to offer threemicroRNA-based tests.
"Rosetta Genomics has made a commitment to deliver its first threemicroRNA-based tests by the end of the year, and today we are just days awayfrom fully delivering on our promise," said Amir Avniel, CEO and President ofRosetta Genomics. "Today, we are announcing the availability of miRview(TM)mets, a test which leverages our proprietary microRNA-based technologies toidentify the primary origin of a metastasis. Our scientists are currentlyfinalizing miRview(TM) meso, and expect it to be added to our test offeringsby the end of the year. We believe our recently introduced miRview(TM) testswill play a key role in enhancing patient care worldwide."
The test's high confidence predictions reach 90% sensitivity with 99%specificity and this relates to the majority cases.
"In contrast to current methods for identifying a metastasis' origin,which may include a wide range of costly, time consuming, and at timesinefficient tests, miRview(TM) mets provides the physician with an accurateidentification of the tumor's origin," noted Dr. Ranit Aharonov, ExecutiveVice President R&D, Head of Computational Biology at Rosetta Genomics. "Wehave designed miRview(TM) mets so that it follows a clear biologicalrationale and it utilizes a relatively small number of molecular markerswhich makes it both a robust and a transparent assay."
In the U.S., hundreds of thousands of patients are diagnosed each yearwith a cancer that has already metastasized. Oncologists and pathologists areconstantly faced with a diagnostic dilemma when trying to identify theprimary origin of a patient's metastasis. As metastases need to be treatedaccording to their primary origin, accurate identification of the metastases'primary origin can be critical for determining appropriate treatment.
For approximately 70,000 patients each year in the US alone, the primaryorigin of the metastases is never identified, and the patient's cancer islabeled "Cancer of Unknown Primary" (CUP). Rosetta Genomics developedmiRview(TM) mets to apply the benefits of microRNA biomarkers for theidentification of tumor origin.
"Joining miRview(TM) squamous, miRview(TM) mets is yet another greatexample of how the benefits of our microRNA biomarkers can be applied inmolecular diagnostics," said Dr. Ayelet Chajut, Executive Vice President R&D,Head of Molecular Biology at the company. "The introduction of our firsttests in a relatively short timeframe attests to our strong R&D capabilitiesand was made possible by the work of our dedicated scientists."
Rosetta Genomics will host a conference call with a simultaneous webcastto discuss the future launch of its products today, Monday December 22, at8:30 a.m. EST.
To access the live conference call, U.S. and Canadian participants maydial 1-866-966-5335; international participants may dial +44-20-3023-4460. Toaccess the 24-hour audio replay, U.S. and Canadian participants may dial1-866-583-1035; international participants may dial +44-20-8196-1998. Theaccess code for the replay is 181543#. The replay will be available untilDecember 30, 2008.
A live audio webcast of the call will also be available on the"Investors" section of the company's website http://www.rosettagenomics.com.An archived webcast will be available on the Company's website approximatelytwo hours after the event, and will be archived for 30 days thereafter.
MicroRNAs (miRNAs) are recently discovered, naturally occurring, smallRNAs that act as master regulators and have the potential to form the basisfor a new class of diagnostics and therapeutics. Since many diseases arecaused by the abnormal activity of proteins, the ability to selectivelyregulate protein activity through microRNAs could provide the means to treata wide range of human diseases. In addition, microRNAs have been shown tohave different expression in various pathological conditions. As a result,these differences may provide for a novel diagnostic strategy for manydiseases.
About Rosetta Genomics
Rosetta Genomics (Nasdaq: ROSG) is a leading developer of microRNA-basedmolecular diagnostics. Founded in 2000, the company's integrative researchplatform combining bioinformatics and state-of-the-art laboratory processeshas led to the discovery of hundreds of biologically validated novel humanmicroRNAs. Building on its strong IP position and proprietary platformtechnologies, Rosetta Genomics is working on the application of thesetechnologies in the development of a full range of microRNA-based diagnostictools. The company's first microRNA-based tests, are now commerciallyavailable through its Philadelphia-based CLIA-certified lab.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta's futureexpectations, plans and prospects, including without limitation, statementsrelating to the role of microRNAs in human physiology and disease, thepotential of microRNAs in the diagnosis and treatment of disease and thetiming of introduction of additional microRNA-based diagnostic tests,including miRview meso, constitute forward-looking statements for thepurposes of the safe harbor provisions under The Private SecuritiesLitigation Reform Act of 1995. Actual results may differ materially fromthose indicated by these forward-looking statements as a result of variousimportant factors, including risks related to: Rosetta's approach to discoverand develop novel diagnostics and therapeutic tools, which is unproven andmay never lead to commercially accepted products or services; Rosetta'sability to fund and the results of further pre-clinical and clinical trials;Rosetta's ability to obtain, maintain and protect the intellectual propertyutilized by Rosetta's products; Rosetta's ability to enforce its patentsagainst infringers and to defend its patent portfolio against challenges fromthird parties; Rosetta's ability to obtain additional funding to support itsbusiness activities; Rosetta's dependence on third parties for development,manufacture, marketing, sales, and distribution of products; Rosetta'sability to successfully develop and commercialize its candidate tools,products and services; Rosetta's ability to obtain regulatory clearances orapprovals that may be required for its products and services; the ability toobtain coverage and adequate payment from health insurers for the productsand services comprising Rosetta's technology; competition from others usingtechnology similar to Rosetta's and others developing products for similaruses; Rosetta's dependence on collaborators; and Rosetta's short operatinghistory; as well as those risks more fully discussed in the "Risk Factors"section of Rosetta's Annual Report on Form 20-F for the year ended December31, 2007 as filed with the Securities and Exchange Commission. In addition,any forward-looking statements represent Rosetta's views only as of the dateof this release and should not be relied upon as representing its views as ofany subsequent date. Rosetta does not assume any obligation to update anyforward-looking statements unless required by law.Contact: Media& Investors Ron Kamienchick T: +1-646-509-1893 E: firstname.lastname@example.org
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