Data Demonstrate RosettaGX Reveal is More Specific Than the Current Market Leader, Sparing Substantially More Unnecessary Surgeries for Patients with Indeterminate Thyroid cytologies
Additional Data Demonstrate the Potential for RosettaGX Reveal Line Extensions that Would Improve its Positive Predictive Value
PHILADELPHIA, PA and REHOVOT, ISRAEL / ACCESSWIRE / October 16, 2017 / Rosetta Genomics Ltd. (NASDAQ: ROSG), a genomic diagnostics company that improves treatment decisions by providing timely and accurate diagnostic information to physicians, today announced data in support of the use of its lead product, RosettaGX Reveal™ ("Reveal"), will be highlighted in two important poster presentations at the upcoming 87th Annual Meeting of the American Thyroid Association (ATA) taking place October 18-22, 2017 in Victoria, British Columbia. The RosettaGX Reveal microRNA classifier is a first-of-its-kind assay offering testing from a routinely prepared cytology slide that analyzes the exact cells used to make the original indeterminate diagnosis.
"We believe the results of this independently conducted comparison study demonstrate one of Reveal's key competitive advantages compared to Afirma®, the current market leader, which is its superior ability to identify true benign cases so as to avoid substantially more unnecessary surgeries," said Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. "These data reinforce our belief that Reveal's competitive advantages provide a strong foundation for Rosetta to continue to make inroads in this market segment. Data like these continue to demonstrate the clinical benefits of using our genomic tests to clarify important patient care decisions that benefit physicians, patients and payers."
The following poster presentations related to RosettaGX Reveal will be delivered during the meeting:
Presentation Title: "RosettaGX Reveal Thyroid miRNA Classifier is a More Specific Test Than Afirma® Gene Expression Classifier"
Presenter: W.L. Sacks, M.D., Division of Endocrinology, Cedars-Sinai Medical Center, Los Angeles, California
Poster Number: Short Call Poster 17
Date: Thursday, October 19th, 2017
Time: 9:30 AM - 4:30 PM
Location: VCC, Crystal Garden
Presentation Title: "BRAF Testing in Conjunction with the RosettaGX Reveal Thyroid miRNA Classifier from a Single FNA Smear"
Presenter: Nicole Massoll, M.D., Lab and Medical Director of Rosetta Genomics
Poster Number: Short Call Poster 31
Date: Friday, October 20th, 2017
Time: 9:30 AM - 4:30 PM
Location: VCC, Crystal Garden
Afirma® is a registered trademark of Veracyte, Inc.
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 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 news release, including but not limited to statements relating to Reveal’s competitive advantages providing a strong foundation for the company to continue to make inroads in the applicable market segment 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 that 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 might not successfully complete the planned sale of our PersonalizeDx business; we have a history of losses and may never be profitable; if we are not able to obtain and enforce patent protection for our discoveries, our ability to develop and commercialize microRNA-based diagnostics and therapeutics could be harmed; if we become involved in patent litigation or other proceedings related to a determination of rights, we could incur substantial costs and expenses, substantial liability for damages or be required to stop our development and commercialization efforts; if third parties from which we license patent rights do not properly maintain or enforce the patents underlying such licenses, our competitive position and business prospects will be harmed; 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; if we do not comply with governmental regulations applicable to our CLIA-certified laboratories, we may not be able to continue our operations; any diagnostic tests that may be developed by us or others using our microRNA technology may be subject to regulatory approval, which can be lengthy, costly and burdensome; failure to comply with government laws and regulations related to submission of claims for our services could result in significant monetary damages and penalties and exclusion from the Medicare and Medicaid programs and corresponding foreign reimbursement programs; if we are found to have violated laws protecting the privacy or security of patient health information, we could be subject to civil or criminal penalties, which could increase our liabilities and harm our reputation or our business; 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; the intensely competitive biotechnology market could diminish demand for our tests and products; 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; failure to comply with federal and state anti-kickback and fraud and abuse laws could result in severe penalties; changes in healthcare policy, including legislation reforming the U.S. healthcare system, may have a material adverse effect on our financial condition and operations; the market may not be receptive to any diagnostic tests or therapeutic products using our microRNA technology upon their commercial introduction; we are largely dependent upon our distributors for the success of commercialization of our current diagnostic tests; there is a substantial risk of product liability claims in our business and if we are unable to obtain sufficient insurance, a product liability claim against us could adversely affect our business; if we are unable to manage the challenges associated with our international operations, the growth of our business could be limited; the Israeli tax benefits that we are currently eligible to receive require us to meet several conditions and may be terminated or reduced in the future, which would increase our costs; we participated in programs supported by the Israeli Chief Scientist, which may restrict the transfer of know-how that we develop; and 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 news 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
[email protected]
LHA Investor Relations
Anne Marie Fields
(212) 838-3777
[email protected]
SOURCE: Rosetta Genomics Ltd.