Study Showing Potential for microRNAs as Biomarkers for Heart Failure Prognosis Published in European Journal of Heart Failure
PHILADELPHIA, PA and REHOVOT, ISRAEL--(Marketwire - Nov 28, 2011) - Rosetta Genomics, Ltd. (NASDAQ: ROSG), a leading developer and provider of microRNA-based molecular diagnostics, announces that results from a joint study by researchers at Rosetta Genomics and the Department of Cardiovascular Medicine, Lady Davis Carmel Medical Center in Haifa, Israel, show that elevated serum levels of specific microRNAs identify systolic heart failure (HF) patients and correlate with important clinical prognostic parameters.
The study, titled "Serum Levels of microRNAs in Patients with Heart Failure," was published online on November 25, 2011, and is set to appear in the December 2011 print edition of the European Journal of Heart Failure. The complete article can be viewed online at: <http://eurjhf.oxfordjournals.org/cgi/content/full/hfr155?>.
In this study, researchers characterized the levels of microRNAs in the sera of chronic systolic HF patients versus controls, and assessed the possible correlation between elevation in the levels of specific microRNAs and clinical prognostic parameters in HF patients.
The levels of 186 microRNAs were measured in the sera of 30 stable chronic systolic HF patients and 30 controls using qRT-PCR. The differences in microRNA levels between the two groups were characterized and a score, based on the levels of four specific microRNAs with the most significant increase in the HF group (miR-423-5p, miR-320a, miR-22, and miR-92b), was defined.
The score, based on serum levels of miR-423-5p, miR-320a, miR-22 and miR-92b identified systolic HF patients and showed correlation with important clinical prognostic parameters.
The score was able to discriminate HF patients from controls with sensitivity and specificity of 90%.
In the HF group, there was a significant association between the score and important clinical prognostic parameters; high microRNA scores were correlated with elevated serum brain natriuretic peptide (BNP) levels (p=0.002), wide QRS (p=0.009), increased end diastolic diameter (p=0.03) and increased left atrial diameter (p=0.01).
Commenting on the clinical utility for such a potential microRNA as prognostic markers, Offer Amir, M.D., Lady Davis Carmel Medical Center & Heart Failure Clinic and the lead author of the study, said, "Diagnosis and risk stratification of patients with HF remain a challenge. The results of this study demonstrated that these four specific microRNAs may indeed serve as biomarkers for the diagnosis and risk stratification of HF patients. Early identification of patients at higher risk for severe HF could lead to earlier intervention that would potentially improve outcomes.
"Previous studies that demonstrated altered levels of microRNAs in the circulation of cardiac patients, combined with an increasing understanding of their role in myocardial injury and remodeling, have led to an appreciation for the potential use of microRNAs as biomarkers of myocardial injury and HF. The results of our current study are consistent with this notion, showing that increased levels of specific microRNAs in the circulation of HF patients may be used as markers for HF diagnosis. With regard to HF severity, our understanding of the clinical impact of microRNAs in HF patients is still in its infancy. However, studies showing correlations between circulating microRNAs and clinical parameters, similar to those reported in our work, are beginning to emerge," added Dr. Amir.
"We are especially pleased with these positive data demonstrating the clinical utility of our serum-based microRNA diagnostic to identify HF patients," said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "With nearly 4.4 million patients diagnosed with HF in the US, there is a very large market opportunity for a simple, blood-based, prognostic test for HF especially given the complexity, prevalence and expense of treating this disease. We have an excellent patent position on this initial microRNA signature and look forward to continuing to advance the development of this potentially powerful, blood-based microRNA diagnostic test for stratification of patients with HF and hope to have it ready to launch by the end of 2013."
About Heart Failure
Heart failure (HF) is a complex clinical syndrome that can result from any structural or functional cardiac disorders that impair the ability of the ventricles to fill with or eject blood. It is the most prevalent disease in the Western world and is the only cardiovascular disease whose prevalence continues to rise. It is estimated that 5 million Americans have HF and approximately 500,000 new cases are diagnosed each year. In addition to its high prevalence, heart failure is also the most expensive disease to treat in Western countries. American Heart Association estimates from 2004 showed that more than $26 billion per year was spent on treating patients with heart failure.
About miRview® Products
miRview® are a series of microRNA-based diagnostic products offered by Rosetta Genomics. miRview® mets and miRview® mets² accurately identify the primary tumor type in primary and metastatic cancer including Cancer of Unknown Primary (CUP). miRview® squamous accurately identifies the squamous subtype of non-small cell lung cancer, which carries an increased risk of severe or fatal internal bleeding and poor response to treatment for certain therapies. miRview® meso diagnoses mesothelioma, a cancer connected to asbestos exposure. miRview® lung accurately identifies the four main subtypes of lung cancer using small amounts of tumor cells. miRview® tests are designed to provide objective diagnostic data; it is the treating physician's responsibility to diagnose and administer the appropriate treatment. In the U.S. alone, Rosetta Genomics estimates that approximately 200,000 patients a year may benefit from the miRview® mets and miRview® mets² test, 60,000 from miRview® squamous, 60,000 from miRview® meso and more than 1 million patients worldwide from miRview lung. The Company's tests are offered directly by Rosetta Genomics in the U.S., and through distributors around the globe. For more information, please visit www.mirviewdx.com. Parties interested in ordering the test can contact Rosetta Genomics at (215) 382-9000 ext. 309.
microRNAs (miRNAs) are recently discovered, small RNAs that act as master regulators of protein synthesis, and have been shown to be highly effective biomarkers. The unique advantage of microRNAs as biomarkers lies in their high tissue specificity, and their exceptional stability in the most routine preservation methods for biopsies, including Formalin Fixed Paraffin Embedded (FFPE) block tissue and fine needle aspirate (FNA) cell blocks. It has been suggested that their small size (19 to 21 nucleotides) enables them to remain intact in FFPE blocks, as opposed to messenger RNA (mRNA), which tends to degrade rapidly. In addition, early preclinical data has shown that by controlling the levels of specific microRNAs, cancer cell growth may be reduced. To learn more about microRNAs, please visit www.rosettagenomics.com.
About Rosetta Genomics
Rosetta Genomics develops and commercializes a full range of microRNA-based molecular diagnostics. 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 patent position and proprietary platform technologies, Rosetta Genomics is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. The Company's miRview product line is commercially available through its Philadelphia-based CAP-accredited, CLIA-certified lab.
Various statements in this release concerning Rosetta's future expectations, plans and prospects, including without limitation, statements relating to the potential of microRNAs in the diagnosis and treatment of disease, 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 microRNA technology and to work on the application of this technology in the development of novel diagnostics and therapeutic tools, which may never lead to commercially accepted products or services; Rosetta's ability to obtain, maintain and protect its intellectual property; Rosetta's ability to enforce its patents against infringers and to defend its patent portfolio against challenges from third parties; Rosetta's need and 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; Rosetta's ability to successfully develop its products and services; Rosetta's ability to obtain regulatory clearances or approvals that may be required for its products and services; the ability to obtain coverage and adequate payment from health insurers for the products and services comprising Rosetta's technology; 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 in the "Risk Factors" section of Rosetta's Annual Report on Form 20-F for the year ended December 31, 2010 as filed with the Securities and Exchange Commission. In addition, any forward-looking statements represent Rosetta's views only as of the date of this release 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.
President & CEO
(215) 382-9000 ext. 326