Molecular test that helps determine treatment can now be performed before the
tumor is surgically resected
* Uses highly accurate microRNA-based technology of miRview squamous test on
Fine-Needle Aspirate (FNA) cell block samples to subclassify non-small cell lung
cancer (NSCLC) into squamous or non-squamous
* Subclassification of NSCLC using preoperative FNA samples currently presents a
challenge to physicians, with an estimated 30%-40% of cases remaining
unclassified or being misclassified
* In a recent study,1 Johns Hopkins University researchers demonstrated that
miRview squamous correctly subclassified 95% of FNA cell block specimens and
small biopsies originally diagnosed as poorly differentiated NSCLC
REHOVOT, Israel & PHILADELPHIA–(Business Wire)–
Rosetta Genomics, Ltd. (NASDAQ:ROSG), a leading developer and provider of
microRNA-based molecular diagnostics, announced today that starting April 1,
2010 physicians are able to send FNA cell block samples to Rosetta Genomics`
CLIA-certified and CAP-accredited laboratory in Philadelphia for analysis using
Rosetta`s miRview squamous test. FNA is a less invasive method to obtain tumor
cells compared with tumor resections or biopsies. This breakthrough will enable
patients and physicians to benefit from a highly accurate diagnostic assay
without having to undergo a more invasive procedure.
miRview squamous is a molecular diagnostic test that measures the expression
level of a single microRNA to accurately differentiate squamous from
non-squamous NSCLC. The test offers patients and physicians a highly accurate
diagnostic tool that produces standardized and reproducible results.
“Enabling physicians to subclassify NSCLC tumors with miRview squamous based on
FNA cell blocks, without the need for more invasive procedures, brings
significant value to lung cancer patient management,” noted Dr. Tina Edmonston,
Director of Rosetta Genomics` CLIA-certified laboratory. “As pathologists, we
are often faced with challenges especially when trying to subclassify poorly
differentiated NSCLCs. However, correct subclassification is crucial to
determine the treatment of the patient. We believe this new capability will help
physicians better address this issue.”
Lung cancer is the leading cause of cancer mortality in the U.S., killing more
than 160,000 Americans annually. In over 60,000 of these patients with NSCLC,
identification of the squamous sub-type has significant clinical implications.
Squamous lung cancer carries increased risk of severe or fatal bleeding for
certain targeted biological therapies, including bevacizumab (Avastin) and other
drugs under development.2 Other approved therapies, such as pemetrexed (Alimta)
are indicated for non-squamous NSCLC only.3
“This improvement is an excellent example of how by adapting our proprietary
miRNA-based technologies to be used on FNA cell block specimens, our highly
accurate miRview squamous assay can be made available to more patients suffering
from lung cancer,” stated Ken Berlin, President and CEO of Rosetta Genomics.
In a recently published study in Clinical Cancer Research, Johns Hopkins
University researchers demonstrated that miRview squamous correctly
subclassified 95% of FNA cell block specimens and small biopsies originally
diagnosed as poorly differentiated NSCLC into squamous and non-squamous cell
carcinoma.
About microRNAs
MicroRNAs (miRNAs) are recently discovered, small RNAs that act as master
regulators of protein synthesis, and have been shown to be highly effective
biomarkers. MicroRNAs` unique advantage 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 (19-21 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 miRview Products
miRview are a series of microRNA-based diagnostic tests developed by Rosetta
Genomics. miRview mets accurately identifies the primary tumor site in
metastatic cancer and Cancer of Unknown Primary. miRview squamous accurately
identifies the squamous subtype of NSCLC, which carries an increased risk of
severe or fatal internal bleeding and poor response to treatment for certain
targeted therapies. miRview meso distinguishes mesothelioma, a cancer connected
to asbestos exposure, from other malignancies in the lung and pleura. 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, over 100,000 patients a year may benefit from the miRview
mets test, 60,000 from miRview squamous, and 60,000 from miRview meso, with
similar numbers of patients outside the U.S. The company`s tests are now being
offered through distributors around the globe. For more information, please
visit www.mirviewdx.com.
About Rosetta Genomics
Rosetta Genomics is a leading developer 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
of a full range of microRNA-based diagnostic tools. The company`s first three
microRNA-based tests, miRview squamous, miRview mets and miRview meso, are
performed at the company`s Philadelphia-based, CLIA-certified and CAP accredited
lab. Rosetta Genomics is the 2008 winner of the Wall Street Journal`s Technology
Innovation Awards in the medical/biotech category. To learn more, please visit
www.rosettagenomics.com.
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 microRNAs in human physiology and disease, and 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, 2009 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.
1 Justin A. Bishop, Hila Benjamin, Hila Cholakh, Ayelet Chajut, Douglas P.
Clark, William Westra. Accurate classification of non-small cell lung carcinoma
using a novel microRNA-based approach. Clinical Cancer Research, 2010, 16(2)
610-619.
2 Johnson et al, Randomized phase II trial comparing bevacizumab plus
carboplatin and paclitaxel with carboplatin and paclitaxel alone in previously
untreated locally advanced or metastatic non-small-cell lung cancer. J Clin
Oncol 22:2184-91, 2004
3 Alimta website at www.alimta.com
Media Contact:
Rosetta Genomics, Ltd.
Ron Kamienchick, 215-382-9000 ext 318
investors@rosettagenomics.com
or
Investors Contacts:
Lippert/Heilshorn & Associates
Anne Marie Fields, 212-838-3777 x6604
afields@lhai.com
or
Bruce Voss, 310-691-7100
bvoss@lhai.com
Copyright Business Wire 2010