RosettaGX Reveal™ Thyroid miRNA Classifier Now Available to Be Utilized on ThinPrep® Samples
September 07 2016 - 8:30AM
Business Wire
Expected to increase demand by more than 50%
over next several months
Updates on Commercial Progress with Reveal
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and
provider of microRNA-based and other molecular diagnostics, today
announces that the Company’s first-of-its-kind microRNA classifier
for indeterminate thyroid nodules, RosettaGX Reveal™ (“Reveal”), is
now available to be utilized on ThinPrep® samples.
“We conducted a study to confirm that RosettaGX Reveal produces
the same high level performance on ThinPrep prepared slides as it
does on a direct smear from a thyroid Fine Needle Aspirate (“FNA”)
biopsy. We are delighted that the data from this study demonstrate
concordance between RosettaGX Reveal when used on ThinPrep, as it
did on FNA smears,” stated Kenneth A. Berlin, President and Chief
Executive Officer of Rosetta Genomics. “ThinPrep has grown in
popularity in recent years due to the convenience it offers the
clinicians that utilize this method for FNA cytology. The study
results confirm that our molecular microRNA analysis is feasible on
ThinPrep slides with the advantage of not requiring additional FNA
passes or fine needle procedures. Unlike other tests in this
market, Reveal is the only test that allows us to analyze the exact
cells that were used to make the initial indeterminate cytology
diagnosis. We believe offering customers the option of using Reveal
with either ThinPrep or direct smears will expand our customer base
and potentially increase our test volumes by greater than 50
percent over the next several months.”
“With the anticipated boost to demand for Reveal from new
customers who currently use ThinPrep, we remain confident in our
ability to achieve a minimum of 200 samples per month by the end of
2016. We received nearly 100 samples last month and our sales team
continues to convert new accounts to Reveal, including several
large volume accounts who have the potential to not only order a
large number of Reveal tests but also to utilize tests from our
other product lines. In addition, we have been able to convert
existing customers of our other product lines to become users of
our Reveal test. Our unique ability to solve customer testing needs
across different areas such as solid tumor profiling, urologic
cancers and indeterminate thyroid FNAs with several proprietary and
leading assays positions us well with larger accounts. These large
accounts benefit from reducing the number of laboratories they need
to work with across several diagnostic areas by working exclusively
with Rosetta Genomics for their testing needs in these areas,”
added Mr. Berlin.
ThinPrep is a registered trademark of Hologic, Inc.
About Rosetta Genomics
Rosetta develops and commercializes a full range of
microRNA-based and other molecular diagnostics. 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. Through the acquisition
of PersonalizeDx, the Company now offers core FISH, IHC and
PCR-based testing capabilities and partnerships in Pathology,
Oncology and Urology that provide additional content and platforms
that complement Rosetta’s microRNA and Next-Gen Sequencing
offerings. RosettaGX Reveal™, a Thyroid microRNA Classifier for the
diagnosis of indeterminate thyroid FNA smears, as well as the full
RosettaGX™ portfolio of cancer testing services are commercially
available through the Company’s Philadelphia, PA- and Lake Forest,
CA-based CAP-accredited, CLIA-certified labs. For more information,
visit www.rosettagx.com.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future
expectations, plans and prospects including, but not limited to
statements relating to increasing demand and testing volume by more
than 50% over the next several months, increasing testing volume
for Reveal and other Rosetta products, expanding the customer base,
converting additional accounts, and achieving a minimum of 200
samples per month by the end of 2016 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 most recently filed Annual Report on Form 20-F, 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.
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version on businesswire.com: http://www.businesswire.com/news/home/20160907005941/en/
Rosetta GenomicsKen Berlin, 267-298-1159President &
CEOinvestors@rosettagx.comorRosetta Genomics
Investor:LHAAnne Marie Fields, 212-838-3777afields@lhai.com
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