Major Clinical Reference Laboratory Selects RosettaGX Reveal Thyroid miRNA Classifier as Molecular Test of Choice
Laboratory's Entire Sales Team to Promote Reveal to All its Customers Throughout the Southwestern United States
PHILADELPHIA, PA and REHOVOT, ISRAEL / ACCESSWIRE / August 21, 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 one of the nation's largest clinical reference laboratories has selected RosettaGX Revealä (Reveal) as their molecular test of choice for indeterminate thyroid nodules (ITNs) for their network of more than 150 pathologists across the Southwestern United States, including Texas, Oklahoma, Louisiana, New Mexico, Nevada and Arizona. Reveal is a thyroid microRNA classifier for the classification of ITNs.
Following an extensive review of all assays currently available for the classification of ITNs, Reveal was selected as their molecular test of choice based on its ease-of-use and its superior negative predictive value that allows patients who receive a benign Reveal test result to undergo active surveillance instead of surgery. This allows for a substantial reduction in the number of unnecessary surgeries since the vast majority of ITNs are benign and surgery on most of these cases is not necessary.
This reference laboratory's extensive network of over 60 sales representatives will be trained on Reveal and will focus on promoting it to endocrinologists, ear, nose and throat (ENT) specialists and family practitioners. Their efforts will also include educating physicians regarding the benefits of molecular testing in the accurate diagnosis of ITNs.
"We are delighted to be partnering with this major reference lab as their extensive network of pathologists should drive continued adoption of Reveal as the molecular assay of choice for ITNs. In addition, we believe that having the lab's large sales team advance the education and promotion of Reveal among a variety of physicians who manage patients with ITNs will be a key to accelerating Reveal revenue throughout the second half of 2017 and beyond," stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics.
"We remain committed to growing Reveal utilization for the classification of ITNs, where many patients with indeterminate results undergo surgery as a precaution despite the fact that up to 80% of those cases are benign. This exposes patients to unnecessary surgical risk and costs the healthcare system hundreds of millions of dollars. We believe that Reveal, with its proprietary classifier algorithm and microRNA signature, can help prevent up to 75% of unnecessary thyroid surgeries and has the potential to save health care payers an average of approximately $6,000 per patient tested with Reveal," added Mr. Berlin.
About Rosetta Genomics
Rosetta is pioneering the field of molecular diagnostics by offering rapid and accurate diagnostic information that enables physicians to make timelier and more 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 having the lab's large sales team advance the education and promotion of Reveal among a variety of physicians who manage patients with ITNs will be a key to accelerating Reveal revenue throughout the second half of 2017 and beyond 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 payers 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.
Ken Berlin, President & CEO
Anne Marie Fields
SOURCE:Rosetta Genomics Ltd.
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