REHOVOT, Israel, JERSEY CITY, New Jersey and PHILADELPHIA, December 11 Rosetta Genomics, Ltd. (NASDQ: ROSG), a leadingdeveloper of microRNA-based molecular diagnostics, announced today thecommercial availability of its first diagnostic test, miRview(TM) squamous.The test is now commercially available through Rosetta GenomicsCLIA-certified lab in Philadelphia.
To order the test, physicians may contact 1-888-522-7971, or visit thecompany's website http://www.rosettagenomics.com.
"The introduction of miRview(TM) squamous, our first microRNA-based test,is a landmark event for us at Rosetta Genomics," said Amir Avniel, Presidentand CEO of Rosetta Genomics. "We are excited to be offering the firstobjective diagnostic test for differentiation of NSCLC patients, which isbased on our proprietary microRNA technology. miRview(TM) squamous offersphysicians a standardized, quantitative diagnostic tool which may assist indetermining the appropriate targeted therapy for NSCLC."
The test has a reported sensitivity of 97%, and a specificity of 91% inidentifying squamous cell lung cancer. Classification accuracy was measuredin a blinded test of a validation set of 64 samples, compared to theconsensus diagnosis of at least two pathologists.
In blinded tests of lab-to-lab concordance, two labs reached the sameclassification in >95% of classified samples.
"We have traveled a significant distance from first discovering microRNAsequences, through the development of our proprietary detection andquantification technologies, to having our first commercially availablemicroRNA-based test," noted Dr. Dalia Cohen, Rosetta Genomics ChiefScientific Office." miRview(TM) squamous is designed to offer a quantitative,objective, and standardized diagnostic tool for differentiating squamous fromnon squamous NSCLC patients. The importance of accurately identifyingsquamous cell lung cancer patients has been receiving growing attention fromthe medical community as data has shown that squamous patients responddifferently to targeted therapies, approved or in advanced development, thannon squamous patients. The difference in response can range from potentialfatal bleeding to poor response."
"Given the varying outcomes of targeted therapies for NSCLC, we viewevery NSCLC patient, who is a candidate for targeted therapy, as a potentialend-user for this test," said Ronen Tamir, Chief Commercialization Officer atRosetta Genomics. "This groundbreaking test, with its high sensitivity andspecificity, will enable doctor and patient to adjust expectations, andanswer a real unmet medical need."
miRview(TM) squamous classifies non-small cell lung carcinoma samplesinto two histological groups: cancers of squamous histology, and non-squamouscancers. The test leverages proprietary microRNA technology developed byRosetta Genomics, and measures the expression level of a microRNA squamousbiomarker to differentiate patients that have squamous cell carcinoma of thelung from patients that have non-squamous non-small cell lung cancer.
Patients with squamous cell carcinoma of the lung have shown varyingresponse patterns to targeted therapies, whether currently available or underdevelopment, ranging from a high incidence of severe or fatal hemoptysis(internal bleeding in the lungs) to overall poor response.
Current methods for differentiating squamous from non squamous non-smallcell lung cancer lack standardization, are difficult to reproduce, and havelow accuracy. Studies that reviewed the accuracy and reproducibility ofhistopathological classification of lung cancer found that 30%~40% of sampleshad been misclassified.
Rosetta Genomics will host a conference call with a simultaneous webcastto discuss the future launch of its products at 8:30 a.m. ET on Monday,December 22.
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 www.rosettagenomics.com. Anarchived webcast will be available on the Company's website approximately twohours 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 test, miRview(TM) squamous, is 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,constitute forward-looking statements for the purposes of the safe harborprovisions under The Private Securities Litigation Reform Act of 1995. Actualresults may differ materially from those indicated by these forward-lookingstatements as a result of various important factors, including risks relatedto: Rosetta's approach to discover and develop novel diagnostics andtherapeutic tools, which is unproven and may never lead to marketableproducts or services; Rosetta's ability to fund and the results of furtherpre-clinical and clinical trials; Rosetta's ability to obtain, maintain andprotect the intellectual property utilized by Rosetta's products; Rosetta'sability to enforce its patents against infringers and to defend its patentportfolio against challenges from third parties; Rosetta's ability to obtainadditional funding to support its business activities; Rosetta's dependenceon third parties for development, manufacture, marketing, sales, anddistribution of products; Rosetta's ability to successfully develop itscandidate tools, products and services, all of which are in early stages ofdevelopment; Rosetta's ability to obtain regulatory clearances or approvalsthat may be required for its products and services; the ability to obtaincoverage and adequate payment from health insurers for the products andservices 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: [email protected]
SOURCE Rosetta Genomics Ltd