Rosetta Genomics' microRNA-based assay for Thyroid Cancer Highlighted in Poster Presentation at 84th Annual Meeting of the Am...
October 23 2014 - 8:00AM
Business Wire
Data demonstrate that specific microRNAs are
differentially expressed between benign and malignant thyroid
lesions
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and
provider of microRNA-based molecular diagnostics, announces that
data in support of the Company’s microRNA-based assay for
indeterminate thyroid nodules will be highlighted in a poster
presentation entitled, “MicroRNAs as a powerful diagnostic tool for
thyroid nodule classification in pre-operative samples,” at the
upcoming 84th Annual Meeting of the American Thyroid Association
(ATA) taking place from October 29th through November 2nd at the
Hotel Del Coronado in Coronado, Calif.
The poster describes the integrated technology platform
developed by Rosetta Genomics for profiling and characterizing
microRNAs in various clinical samples including cytological
samples, cell blocks and stained smears. Over 150 thyroid Fine
Needle Aspirate (FNA) samples in cell blocks and stained smears
were successfully processed and profiled using Rosetta's
proprietary microarray platform measuring over 2000 microRNAs.
Differential expression of microRNAs was found between benign and
malignant neoplasms. In addition, next generation sequencing was
performed on a set of 11 thyroid follicular resection samples in
which 386 novel candidate microRNAs were found, 27 of them were
also measured using qPCR.
The study concluded, “We demonstrated the feasibility of
extracting and profiling miRNAs from cell blocks and smears stained
with different cytological stains. We also identified novel
microRNAs using proprietary small-RNA next generation sequencing,
which may serve as new biomarkers for the classification of thyroid
nodules. Using the expression levels of just two microRNAs, we can
reach an accuracy of over 85% in discriminating benign from
malignant thyroid nodules.”
“We are delighted to have these supportive data presented at
this year’s ATA as it raises awareness of Rosetta’s new
microRNA-based thyroid cancer assay, which is currently under
development and expected to launch in the third quarter of 2015,
before an audience of clinicians who specialize in the diagnosis
and treatment of thyroid disorders and thyroid cancer,” stated
Kenneth A. Berlin, President and Chief Executive Officer of Rosetta
Genomics. “These data corroborate the results from our earlier
studies, which have demonstrated that microRNA expression levels
can differentiate malignant nodules from benign nodules, and also
demonstrated the ability to extract and profile microRNAs from
thyroid FNAs. We are in the process of conducting larger validation
studies, as we plan for the launch of our thyroid assay in the U.S.
in 2015.”
An estimated 4% to 7% of the general population develops nodules
in the thyroid that can be felt on examination, though fewer than
10% are malignant. The use of FNAs to obtain tissue for analysis is
the standard biopsy technique for detecting thyroid cancer. It is
estimated that nearly 500,000 FNAs are performed each year in the
U.S. and approximately 740,000 are performed annually in Europe.
Interpretation of thyroid FNA samples is not always
straightforward, leading to an indeterminate result in up to 30% of
the samples. Many patients with indeterminate results are sent to
surgery as a precaution, despite the fact that the majority of
these cases are benign. This exposes patients to unnecessary
surgical risk, potential co-morbidities, and costs the system
hundreds of millions of dollars.
About the American Thyroid Association
The American Thyroid Association (ATA) is the leading
worldwide organization dedicated to the advancement, understanding,
prevention, diagnosis, and treatment of thyroid disorders and
thyroid cancer. ATA is an international membership medical society
with over 1,700 members from 43 countries around the world.
Celebrating its 91st anniversary, the ATA delivers its mission — of
being devoted to thyroid biology and to the prevention and
treatment of thyroid disease through excellence in research,
clinical care, education, and public health — through several key
endeavors: the publication of highly regarded professional
journals, Thyroid, Clinical Thyroidology, and VideoEndocrinology;
annual scientific meetings; biennial clinical and research
symposia; research grant programs for young investigators, support
of online professional, public and patient educational programs;
and the development of guidelines for clinical management of
thyroid disease and thyroid cancer. The ATA promotes thyroid
awareness and information through its online Clinical Thyroidology
for the Public (distributed free of charge to over 11,000 patients
and public subscribers) and extensive, authoritative explanations
of thyroid disease and thyroid cancer in both English and Spanish.
The ATA website serves as the clinical resource for patients and
the public who look for reliable information on the Internet.
About Rosetta Genomics
Founded in 2000, Rosetta’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 is working on the
application of these technologies in the development and
commercialization of a full range of microRNA-based diagnostic
tools and therapeutics. Rosetta currently commercializes a full
range of microRNA-based molecular diagnostics. Rosetta’s cancer
testing services are commercially available through its
Philadelphia-based CAP-accredited, CLIA-certified lab. For more
information, 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 utility of scientific data presented by
Rosetta, the presentation of scientific data by Rosetta at the ATA,
the development of a high-value thyroid cancer diagnostic and the
expected timing of the launch of Rosetta’s thyroid assay in the
U.S., 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 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, 2013 as filed
with the SEC. 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.
Rosetta Genomics Contact:Rosetta GenomicsKen Berlin,
President &
CEO609-419-9003investors@rosettagenomics.comorInvestor
Contacts:LHAAnne Marie
Fields212-838-3777afields@lhai.comorBruce
Voss310-691-7100bvoss@lhai.com
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