RosettaGX Reveal™ Analytical Validation Study Featured on the Cover of the October Issue of Cancer Cytopathology
24 Octobre 2016 - 2:30PM
Business Wire
Previously available online, print article
enhances awareness of the first commercial test validated to
analyze the same thyroid cells on which the initial indeterminate
diagnosis was based
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and
provider of microRNA-based and other molecular diagnostics,
announces that an article highlighting the analytical validation
data from a study of the Company’s novel, microRNA-based assay for
the classification of indeterminate thyroid nodules is featured on
the cover of the October issue of the peer-reviewed
journal, Cancer Cytopathology.
These data were previously published in the journal’s online
edition in an article titled “Analytical Validity of a
microRNA-based Assay for Diagnosing Indeterminate Thyroid FNA
Smears from Routinely Prepared Cytology Slides,” and highlights the
robustness of RosettaGX Reveal™. This assay classifies
indeterminate thyroid nodules as “benign,” “suspicious for
malignancy by microRNA profiling” or “positive for medullary
carcinoma.” The Reveal assay is run preoperatively on existing
cytology smears from Fine Needle Aspiration (FNA) biopsy
procedures. The Reveal assay does not require any additional passes
or repeat FNA biopsies. It can also be run on historical specimens.
Although the Reveal assay can correctly classify samples with low
numbers of thyroid cells, it does not mistakenly diagnose samples
that do not contain any thyroid material as reported for other
molecular tests.
These published data report that the assay was found to be
robust to varying physical processing conditions and to differing
characteristics of the samples. The study also shows the classifier
results are reproducible across operators, processing runs, reagent
lots and laboratories.
The study authors conclude that, “Given the assay's performance,
robustness and utilization of routinely prepared FNA slides, it has
the potential to provide valuable aid for physicians in the
diagnosis of thyroid nodules.”
“We are delighted to have our analytical validation study as the
cover story in Cancer Cytopathology as it recognizes the high level
of interest in this groundbreaking assay and its robustness to
various conditions. This peer-reviewed journal of the American
Cancer Society is considered a premier publication in its field,
and is widely read by cytopathologists, a key target audience for
our Reveal assay,” said Kenneth A. Berlin, President and Chief
Executive Officer of Rosetta Genomics.
“Since the online publication of these data in May 2016, we have
seen rapid growth in demand for Reveal to help resolve ambiguity in
indeterminate thyroid cancer diagnoses and, thus, reduce
unnecessary surgeries. We expect the added exposure of having
Reveal featured on the cover of Cancer Cytopathology will build
upon this momentum,” added Mr. Berlin.
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 building momentum 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/20161024005681/en/
Rosetta Genomics:Ken Berlin, 267-298-1159President &
CEOinvestors@rosettagx.comorRosetta Genomics Investor
Contact:LHAAnne Marie Fields, 212-838-3777afields@lhai.com
Rosetta Genomics (CE) (USOTC:ROSGQ)
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