98% Negative Predictive Value (NPV), 95%
Sensitivity and 79% Specificity when three pathologists agree on
reference diagnoses; 90% NPV overall
Launches RosettaGX Reveal™ at leading thyroid
medical conference
Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and
provider of microRNA-based and other molecular diagnostics,
announces that performance and other data from the
recently-completed, blinded validation study of its microRNA-based
diagnostic assay for the classification of indeterminate thyroid
nodules is being presented in a poster entitled “A
First-of-its-Kind, microRNA-based Diagnostic Assay for Accurate
Thyroid Nodule Classification,” at the 15th International Thyroid
Congress (ITC) and 85th Annual Meeting of the American Thyroid
Association (ATA). The meeting is taking place October 18-23, 2015
in Lake Buena Vista, Florida. The poster is being presented by
Dganit Bar, Ph.D., Chief Scientific Officer of Rosetta Genomics,
and Eti Meiri, Ph.D., Vice President of Research of Rosetta
Genomics, on Wednesday, October 21st at 9:20 a.m. Eastern time
during a poster presentation session taking place at the Atlantic
Hall, Dolphin Building of the Walt Disney World Swan and Dolphin
Resort (Orlando). The poster can be accessed here.
Branded as RosettaGX Reveal™ and being launched at the ITC/ATA,
this simple and reliable diagnostic assay 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.
The multicenter blinded validation study was conducted on 203
Fine Needle Aspiration (FNA) smears collected from centers in the
U.S., Europe and Israel. 192 (94.6%) passed quality assurance (QA)
measures. The samples were processed according to standard
operating procedures by personnel blinded to the reference
diagnosis, and classifications were automatically generated by a
dedicated software algorithm.
Performance data from the study showed that where final
diagnosis was unanimously confirmed by three pathologists (n=159),
the highest standard reference diagnoses, RosettaGX Reveal
demonstrated a Sensitivity of 95%, Specificity of 79%, Negative
Predictive Value (NPV) of 98% and Positive Predictive Value (PPV)
of 63%.
The overall sample set (n=203 before QA; 192 following QA),
where the final diagnoses were agreed to by at least two
pathologists, demonstrated a Sensitivity of 84%, Specificity of
72%, NPV of 90% and PPV of 60%.
Commenting on the validation data and the introduction of
RosettaGX Reveal, Nicole Massoll, M.D., Medical Director of
Cytopathology at the University of Arkansas for Medical Sciences
and a medical director for FNApath Laboratories, said, These
performance data are very impressive, especially with regard to the
NPV of 98% achieved for the samples for which three expert
pathologists agreed on the final diagnosis. A high NPV is important
because patients with indeterminate nodules are often referred to
surgery, though most of these nodules prove to be benign. In
addition to its performance, we look forward to using RosettaGX
Reveal because we can work off the same cytology slides that were
created to perform the initial diagnosis, thus eliminating the
risks, morbidity and unnecessary pain associated with a second fine
needle passage into the patient's neck, and also allowing Rosetta’s
test to be run on the same cells we have already examined.”
“We are delighted to be introducing our RosettaGX Reveal test
before an audience of the world’s leading thyroid disease experts.
We are particularly pleased with the outstanding performance data
of our diagnostic assay as it demonstrates significant improvement
over currently available tests. Moreover, RosettaGX Reveal is the
only currently available assay that can be run on very small
samples and smears. This flexibility, coupled with superior
clinical performance, should provide considerable competitive
advantage as we launch RosettaGX Reveal into an annual market
valued at $350 million in the U.S. alone,” said Douglas Sites,
Executive Vice President, Sales and Marketing for Rosetta
Genomics.
“We believe RosettaGX Reveal is an exceptionally competitive
product compared with currently marketed assays, and we look
forward to submitting these positive data for publication in a
leading peer-reviewed journal by the end of this year. The results
of our validation study once again demonstrate the power of
microRNAs as biomarkers and show exceptional assay performance when
our microRNA-based testing results are compared with the highest
standard reference diagnoses. We remain confident this will be an
important product for our portfolio as practice guidelines already
recognize the value of molecular profiling in cases where the
initial diagnoses for an FNA thyroid smear is indeterminate. This
fact, combined with the obvious health economic benefits this test
will bring by avoiding unnecessary surgeries, creates prime market
conditions that should encourage market adoption. In addition, this
assay has the potential to provide benefits to patients with
thyroid nodules as it can help ensure that their condition is
handled most appropriately,” said Kenneth A. Berlin, President and
Chief Executive Officer of Rosetta Genomics.
“In addition to the clinical benefits and competitive
performance of RosettaGX Reveal, our recently announced partnership
with FNApath provides physicians initially testing their patients
for thyroid cancer with the option of using a pathologist or
laboratory of their own choosing, or FNApath, a centralized
laboratory with an expertise in diagnosing thyroid cancer.
Currently, the market-leading test for indeterminate thyroid cancer
FNAs in most cases requires physicians to send patient FNA samples
to that company’s designated centralized laboratory, thereby
preventing physicians from working with the local pathologist of
their choice, and in the case of an indeterminate result, requiring
two additional FNA samples be drawn in order to run their test,”
added Mr. Berlin.
About Rosetta Cancer Testing Service
Rosetta Cancer Tests are a series of microRNA-based diagnostic
testing services offered by Rosetta Genomics. The Rosetta Cancer
Origin Test™ can accurately identify the primary tumor type in
primary and metastatic cancer including cancer of unknown or
uncertain primary (CUP). The Rosetta Lung Cancer Test™ accurately
identifies the four main subtypes of lung cancer using small
amounts of tumor cells. The Rosetta Kidney Cancer Test™ 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 Rosetta Cancer Origin
Test™, 62,000 patients a year from the Rosetta Kidney Cancer Test™,
222,000 patients a year from the Rosetta Lung Cancer Test™ 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 relating to Rosetta’s RosettaGX Reveal assay
improving on currently available tests, the sensitivity,
specificity, positive and negative predictive values of Rosetta’s
RosettaGX Reveal assay, the value of the market for RosettaGx
Reveal, the submission of the aforementioned data for publication,
the health economic benefits that RosettaGx Reveal will bring, the
competitive advantages and market conditions that should encourage
market adoption of RosettaGx Reveal, and that RosettaGx Reveal will
become an important part of Rosetta’s product portfolio 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.
View source
version on businesswire.com: http://www.businesswire.com/news/home/20151021005178/en/
Company:Rosetta GenomicsKen Berlin, 609-419-9003President
& CEOinvestors@rosettagenomics.comorInvestors:LHAAnne
Marie Fields, 212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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