Also Expands Patent Portfolio for Therapeutics and Diagnostics with Allowances in the U.S.
PHILADELPHIA, PA and REHOVOT, ISRAEL / ACCESSWIRE / September 6, 2017 / Rosetta Genomics Ltd. (NASDAQ: ROSG), a genomic
diagnostics company that improves treatment decisions by providing timely and accurate diagnostic information to physicians,
announces that The Japan Patent Office (JPO) has allowed a patent that expands the global patent protection for its lead product,
RosettaGX Reveal™ (Reveal), a Thyroid microRNA Classifier, for classifying indeterminate thyroid nodules. In addition, the Company
has expanded its patent portfolio for therapeutics and diagnostics with patent allowances in the United States
The JPO has granted the Company a Notice of Allowance for JP Patent Application No. 2016-567582, relating to the Company's
Reveal assay, covering a method of classifying a thyroid lesion sample as malignant or benign, based on a classifier algorithm
applied to the expression profile of a set of microRNAs obtained from Fine Needle Aspirate (FNA) samples.
The United States Patent and Trademark Office (USPTO) has also granted the Company and a third party a patent allowance for US
Patent Application 15/334,422, relating to a method of treating liver cancer through the use of a compound comprising a modified
oligonucleotide comprising a sequence complementary to miR-191-5p. This patent is co-owned by the Company and the third party.
In addition, the USPTO has granted Rosetta Genomics a patent allowance for US Patent Application No. 14/592,111, relating to a
method of classifying a liver cancer as hepatocellular carcinoma or liver metastasis based on the expression of miR-220c.
"We remain committed to fortifying our global leadership in microRNA intellectual property and these patent allowances will
further strengthen that position," noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "We are
focusing our commercial efforts on Reveal and believe that this emphasis on the promotion of Reveal provides the shortest path to
profitability."
"We continue to expand our international commercial business through our existing distributorships for Reveal with Rhenium in
Israel and Cytolog in Brazil. We have seen an uptick in international demand for Reveal primarily due to the ease-of-use of Reveal,
which is especially important in international markets where the ability to process the Reveal assay from original FNA smears
provides customers with significantly simpler shipping and other logistics compared with competing tests in this class. We plan to
expand further in other larger ex-US geographies such as Japan through licenses or distributorships and this Japanese patent
allowance is expected to support this endeavor."
About Rosetta Genomics
Rosetta is pioneering the field of molecular diagnostics by offering rapid and accurate diagnostic information that enables
physicians to make more timely and informed treatment decisions to improve patient care. Rosetta has developed a portfolio of
unique diagnostic solutions for oncologists, urologists, endocrinologists, cytopathologists and other specialists to help them
deliver better care to their patients. RosettaGX RevealTM, a Thyroid microRNA Classifier for classifying indeterminate thyroid
nodules, 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.
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 our belief that focusing on Reveal is the shortest path to profitability and statements containing the words
"expect," "believe," "will," "may," "should," "project," "estimate," "anticipated," "scheduled," and like expressions, and the
negative thereof, 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 risks and uncertainties, including, but are not limited to the following: we will require substantial additional
funds to continue our operations and, if additional funds are not available, we may need to significantly scale back or cease our
operations; we have a history of losses and may never be profitable; if we are unable to expand sales of our diagnostic tests in
the United States, it would have a material adverse effect on our business and financial condition; if we are unable to find
profitable strategic alternatives for our PersonalizeDx diagnostic testing and services business, it would have a material adverse
effect on our business and financial condition; the intensely competitive biotechnology market could diminish demand for our tests
and products; the market may not be receptive to any diagnostic tests or therapeutic products using our microRNA technology; we
currently have limited sales, marketing or distribution experience and may in the future depend significantly on third parties to
commercialize microRNA-based diagnostic tests or therapeutic products we may develop; we are largely dependent upon our
distributors for the success of commercialization of our current diagnostic tests; health insurers and other third-party payors may
decide not to cover our diagnostic products or may provide inadequate reimbursement, which could jeopardize our commercial
prospects; because of Medicare billing rules, we may not receive reimbursement for all tests provided to Medicare patients; if we
fail to comply with our obligations under any licenses or related agreements, we could lose license rights that may be necessary
for developing microRNA-based diagnostics and therapeutics; if we fail to comply with the complex federal, state, local and foreign
laws and regulations that apply to our business, we could suffer severe consequences that could materially and adversely affect our
operating results and financial condition; we contract with a single manufacturer for the purchase of microarray chips for certain
tests, and the failure of this manufacturer to supply sufficient quantities on a timely basis could have a material adverse effect
on our business; and other risk factors discussed under the heading "Risk Factors" in 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.
Various statements in this release concerning Rosetta's future expectations, plans and prospects 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.
Rosetta Genomics Contact:
Rosetta Genomics Investor Contact: Ken Berlin, President & CEO (267) 298-1159 investors@rosettagx.com
LHA Anne Marie Fields (212) 838-3777 afields@lhai.com
SOURCE: Rosetta Genomics Ltd.
