Positive Performance Data from Validation Study of Rosetta Genomics’ microRNA-based Diagnostic Assay for Thyroid Nodule Classification Presented at the International Thyroid Congress and Annual Meeting of the American Thyroid Association

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

PHILADELPHIA & REHOVOT, Israel–(BUSINESS WIRE)–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, PGxOneand 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.


Rosetta Genomics
Ken Berlin, 609-419-9003
Marie Fields, 212-838-3777
Voss, 310-691-7100