Rosetta Genomics Expands Patent Portfolio in Canada, United States, and China

Canadian Patent Allowance Expands Coverage for RosettaGX Reveal™ Thyroid MicroRNA Classifier

PHILADELPHIA, PA and REHOVOT, ISRAEL / ACCESSWIRE / July 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 it has expanded its global patent portfolio with the following patent office grants and notification:

  • The Canadian Intellectual Property Office has granted a patent allowance for CA Patent Application No. 2,945,531, relating to "miRNA Expression Signature in the Classification of Thyroid Tumors," which claims a method of classifying a thyroid lesion sample obtained by fine needle aspiration as malignant or benign, through a classifier algorithm that utilizes the expression profile of microRNAs.
  • The United States Patent and Trademark Office has granted a patent allowance for US Patent Application No. 14/284,256, which claims a method of distinguishing between primary and metastatic gastrointestinal tumor, through the expression profile of microRNAs.
  • The Chinese Patent Office has issued a notification to grant a patent for CN Patent Application No. 201280025062.7, relating to "Methods and Compositions for Determining Heart Failure and or a Risk of Heart Failure," which claims the use of a primer or a probe for detecting microRNAs in the manufacture of a kit for diagnosing or prognosticating chronic heart failure in a subject.

"We remain committed to fortifying our global leadership in microRNA intellectual property, and these patent actions further strengthen that position," noted Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "Near-term, we are focused on U.S. commercial efforts for RosettaGX Reveal™, our thyroid microRNA classifier for the diagnosis of cancer in indeterminate thyroid nodules, and on international expansion of this assay through distributors such as our recently-formed relationships with Rhenium in Israel and Cytolog in Brazil. As we look to expand further in other geographies, this Canadian patent allowance will help in 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 Reveal™, a Thyroid microRNA Classifier for the diagnosis of cancer in 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 fortifying our global leadership in microRNA intellectual property, expanding internationally, focusing on US commercial efforts for RosettaGX Reveal™ 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:

Ken Berlin, President & CEO
(267) 298-1159
investors@rosettagx.com

Rosetta Genomics Investor Contact:

LHA
Anne Marie Fields
(212) 838-3777
afields@lhai.com

SOURCE: Rosetta Genomics Ltd.

ReleaseID: 467453

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