Rosetta Genomics to Partner with FNApath to Provide Centralized Laboratory Testing Services for Thyroid Cancer
September 30 2015 - 9:15AM
Centralized Laboratory With Expertise in
Thyroid Cancer Cytopathology to Enhance Rosetta's New Assay
Offering for Indeterminate Thyroid Cancer Cases
Rosetta Expects to Release Performance
Data on Its New Assay at the Upcoming 15th International Thyroid
Congress
Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and
provider of microRNA-based and other molecular diagnostics,
announces that the Company has reached an agreement-in-principle
with FNApath of Little Rock, Arkansas, under which Rosetta Genomics
will provide endocrinologists 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. In the event of an
indeterminate result, the sample would then be tested with
RosettaGx Thyroid Reveal™, the Company's thyroid neoplasia assay
for the differential diagnosis of indeterminate fine needle
aspirates (FNAs).
Currently, the market-leading test for indeterminate thyroid
cancer FNAs in most cases requires physicians to send their
patients' 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.
"Interpretation of FNA samples from thyroid nodules is not
always straightforward, which leads to an indeterminate result in
up to 30% of the samples. Many patients with indeterminate results
are sent to surgery as a precaution, despite the fact the majority
of these cases are benign. This exposes patients to unnecessary
surgical risk and costs the system hundreds of millions of
dollars," stated Kenneth A. Berlin, President and Chief Executive
Officer of Rosetta Genomics.
"Our goal with this partnership is to give endocrinologists the
option of working with the pathologists they know and trust for the
initial interpretation of the sample, or to use our designated
experts. This open platform eliminates the penalty of having to
secure another FNA from the patient in order to further examine the
sample for a more accurate diagnosis and classification. In
addition, the RosettaGx Thyroid Reveal test can be run on very
small samples and smears. This flexibility, coupled with other
features and benefits of this assay, should provide considerable
competitive advantage for RosettaGx Thyroid Reveal," said Douglas
Sites, Executive Vice President, Sales and Marketing for Rosetta
Genomics.
Commenting on the partnership, Nicole Massoll, M.D., medical
director for FNAPath Laboratories, said, "We are especially pleased
to be working with Rosetta Genomics' cutting-edge diagnostic assay,
RosettaGx Thyroid Reveal, as we believe it has the potential to be
the most effective and efficient assay for the accurate diagnosis
and classification of indeterminate thyroid FNAs. One of the
advantages of using RosettaGx Thyroid Reveal is that we can work
off the same cytology slides that are initially created to perform
the upfront 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 very cells that the cytopathologist has already
examined. We believe this partnership will give physicians the
optionality they want with the superior test results they need for
their patients with an indeterminate thyroid cancer diagnosis."
Rosetta Genomics expects to introduce its RosettaGx Thyroid
Reveal assay and to report on its clinical performance at the
upcoming 15th International Thyroid Congress (ITC) and 85th Annual
Meeting of the American Thyroid Association (ATA) taking place
October 18-23, 2015 in Lake Buena Vista, Florida. The ITC is a
collaborative meeting held every fifth year by the four world
thyroid associations: ATA, Asia-Oceania Thyroid Association (AOTA),
European Thyroid Association (ETA) and Latin American Thyroid
Society (LATS). The ITC will bring together the international
community of endocrine specialists, surgeons and other health
professionals to present and discuss the latest research and
developments in thyroidology. The four international thyroid
associations combine their efforts to contribute to this
one-of-a-kind, state-of-the-science experience.
"We look forward to introducing RosettaGx Thyroid Reveal at the
ITC, as it is the largest meeting of endocrinologists and others
dedicated to making advances for patients with thyroid
disease. It is particularly fortuitous for Rosetta that this
Congress, which takes place once every five years, coincides with
our expected market introduction and presentation of results from
our validation testing for RosettaGx Thyroid Reveal. We
believe that RosettaGx Thyroid Reveal's clinical benefits and
competitive advantages will be of interest to this audience of
thyroid specialists," added Mr. Berlin.
About Rosetta Genomics
Rosetta develops and commercializes a broad range of
microRNA-based and other high-value 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 also 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 cancer testing services
are commercially available through the Philadelphia, PA- and Lake
Forest, CA-based CAP-accredited, CLIA-certified labs. 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 the expected timing of the
launch of Rosetta Genomics' thyroid assay, Rosetta
Genomics executing a definitive agreement with FNApath, Rosetta
Genomics' thyroid assay providing a more accurate diagnosis
and classification for Thyroid tumors, Rosetta Genomics'
thyroid assay reducing the amount of FNA 'passes' into a
patients neck and Rosetta Genomics' thyroid
assay being the most effective and efficient assay for
the accurate diagnosis and classification of indeterminate thyroid
FNAs, 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.
Company
Contacts:
Rosetta
Genomics
Ken Berlin, President &
CEO
(609)
419-9003
investors@rosettagenomics.com
Investor
Contacts:
LHA
Anne Marie Fields (212) 838-3777 afields@lhai.com or Bruce Voss
(310) 691-7100 bvoss@lhai.com
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