Rosetta Provides Update on Performance Data and Launch of RosettaGX Reveal™ (Thyroid microRNA Classifier)
November 12 2015 - 8:58AM
Business Wire
Sensitivity and Negative Predictive Value in
key Sub-Classes Establishes New Standard in Industry
Beginning to Receive and Process Commercial
Samples
Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and
provider of microRNA-based and other molecular diagnostics,
announces additional performance data from the recently-completed,
blinded validation study of RosettaGX Reveal™, its microRNA-based
diagnostic assay for the classification of indeterminate thyroid
nodules.
The “gold standard” for diagnosis is agreement among the three
pathologists involved in the study. When compared to this “gold
standard,” new data demonstrate particularly strong performance in
Bethesda classes III and IV of the Bethesda System for Reporting
Thyroid Cytopathology (TBSRTC), where the risk of malignancy is
low, yet many of these patients are still sent to surgery. The
Company expects these data to be published in a peer-reviewed
journal in the coming months.
The high sensitivity, specificity and Negative Predictive Value,
as presented at the recent International Thyroid Congress (ITC),
along with the strong performance data in Bethesda classes III and
IV, are important because patients with indeterminate nodules often
have their thyroid surgically removed despite the fact that most of
these nodules prove to be benign. Based on the results from a
multi-center, blinded validation study, RosettaGX Reveal could
prevent more than 70% of these unnecessary surgeries.
The strong performance demonstrated by the RosettaGX Reveal
validation study provides physicians with a high level of
confidence when considering whether to forego surgery in cases
where a patient has an indeterminate thyroid nodule.
RosettaGX Reveal™ was launched at the ITC. It is a simple and
reliable diagnostic assay that offers a valuable tool for the
classification of pre-operative thyroid samples, including those
that are presently indeterminate according to cytological
evaluation, and is the only assay that can utilize cytology smears.
This assay is the first commercial test that interrogates the same
thyroid cells that the cytopathologist viewed for the initial
indeterminate diagnosis, which provides a significant level of
convenience versus other tests as it eliminates the risks,
morbidity and unnecessary pain associated with a second fine needle
passage into the patient's neck.
“As we continue to analyze and parse the data from our
multi-center, blinded validation study for RosettaGX Reveal, our
confidence grows in its exceptional performance and in our belief
that it will be a very competitive assay,” said Kenneth A. Berlin,
President and Chief Executive Officer of Rosetta Genomics.
“We were particularly pleased to receive our first commercial
orders for RosettaGX Reveal at our laboratory in Philadelphia last
week and again this week. This early response to our initial
launch, underscores our confidence that RosettaGX Reveal will be an
important driver of revenue growth over the next several years. We
are excited about the potential for this assay to benefit patients
with thyroid nodules as it can help ensure that their condition is
handled most appropriately and in a most convenient manner for the
patient and the practitioner.”
About Rosetta Cancer Testing Service
Rosetta Cancer Tests are a series of microRNA-based diagnostic
testing services offered by Rosetta Genomics. RosettaGX Cancer
Origin™ can accurately identify the primary tumor type in primary
and metastatic cancer including cancer of unknown or uncertain
primary (CUP). The mi-LUNG™ assay accurately identifies the four
main subtypes of lung cancer using small amounts of tumor cells.
The mi-Kidney™ assay accurately classifies the four most common
kidney tumors: clear cell renal cell carcinoma (RCC), papillary
RCC, chromophobe RCC and oncocytoma. Rosetta’s assays are designed
to provide objective diagnostic data. In the U.S. alone, Rosetta
Genomics estimates that 150,000 patients a year may benefit from
the RosettaGX Cancer Origin, 62,000 patients a year from the
mi-Kidney assay, 222,000 patients a year from the mi-Lung assay and
150,000 patients a year from RosettaGX Reveal™ for indeterminate
thyroid FNAs. The Company’s assays are offered directly by Rosetta
Genomics in the U.S., and through distributors around the world. In
addition to its proprietary products, the Company markets the
RosettaGX OncoGxOne, OncoGxLung, PGxOne™ and EGFR and KRAS tests
for Admera Health. With the acquisition of PersonalizeDx in April
2015, the Company now offers a broader menu of molecular and other
assays for bladder, lung, prostate and breast cancer patients. For
more information, please visit www.rosettagenomics.com. Parties
interested in ordering any of these tests can contact Rosetta
Genomics at (215) 382-9000 ext. 309.
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 offers core FISH, IHC and PCR-based
testing capabilities and partnerships in oncology and urology that
provide additional content and platforms that complement the
Rosetta offerings. Rosetta’s and PersonalizeDx’s cancer testing
services are commercially available through the Philadelphia, PA-
and Lake Forest, CA-based CAP-accredited, CLIA-certified labs,
respectively. For more information visit
www.rosettagenomics.com.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future
expectations, plans and prospects, including but not limited
to statements that data is expected to be published in a
peer-reviewed journal in the coming months; that RosettaGX Reveal
could prevent more than 70% of unnecessary surgeries; that
RosettaGX Reveal will be very competitive assay; and that RosettaGX
Reveal will be an important driver of revenue growth over the next
several years, 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, 2014 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/20151112005794/en/
Company:Rosetta GenomicsKen Berlin, President & CEO,
609-419-9003investors@rosettagenomics.comorInvestor
Contacts:LHAAnne Marie Fields,
212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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