Rosetta Genomics Receives Key U.S. Patent Allowance for its Novel Kidney Cancer Test
March 26 2015 - 8:30AM
Business Wire
Covers key claims for microRNA diagnostic which
distinguishes the four different types of kidney cancer in order to
reduce unnecessary surgery and guide treatment decisions
Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and
provider of microRNA-based molecular diagnostics, announces receipt
of a Notice of Allowance for U.S. Patent Application No.
13/412,020, entitled, “Gene Expression Signature for Classification
of Kidney Tumors.” The patent is owned jointly with Tel Hashomer
Medical Research Ltd., the technology transfer company of the Chaim
Sheba Medical Center in Israel.
The allowed patent claims a method for distinguishing four
different types of kidney cancer: oncocytoma, clear cell renal cell
carcinoma (RCC), papillary (chromaphil) RCC and chromophobe RCC in
a human subject with renal cancer, through the expression profile
of a unique set of 24 microRNAs and a classifier algorithm.
The impact of the limitation of diagnostic capability in renal
oncocytoma was highlighted by a recent health economics outcome
review of the management of kidney masses1. This study clearly
demonstrated the adverse economic and health outcomes impact of
poor pre-operative diagnosis, and confirmed the reported very low
rates of pre-nephrectomy biopsy. In their analysis of the IMS
LifeLink database, covering more than 60 million commercially
insured patients in the U.S., the authors found that approximately
1 in 6 who underwent a nephrectomy for suspected renal cell cancer
were subsequently identified as having benign disease, with an
economic impact of approximately $26,500 per patient. This is in
contrast to total expenditures of approximately $1,300
pre-operatively today, most commonly for one or more CT
examinations. They projected that this represents more than 10,000
unnecessary surgeries annually in the U.S. alone.
“This U.S. patent allowance will provide core protection for the
Rosetta Kidney Cancer Test which accurately distinguishes between
the four main subtypes of kidney cancer. We believe that the
different long-term prognosis for these four subtypes makes the
correct pathological diagnosis of a renal cancer critically
important for the clinician, especially for oncocytomas so as to
avoid unnecessary surgeries, ” said Kenneth A. Berlin, President
and Chief Executive Officer of Rosetta Genomics. “In addition to
reducing the number of unnecessary surgeries in the case of
oncocytomas, new molecularly-targeted therapeutics for kidney
cancer are making accurate sub-classification of tumor type
important for optimizing treatment choices and improving
outcomes.”
“With 42 issued patents, four allowed patents and 46 patents
pending worldwide, our growing intellectual property position
continues to provide protection for and solidify our global
leadership position in microRNA biomarker technology and in
creating differentiated and proprietary content in the area of
personalized medicine,” concluded Mr. Berlin.
Kidney cancer is among the ten most common cancers in both men
and women. Kidney cancers account for more than 3% of adult
malignancies and cause more than 14,000 deaths per year in the U.S.
alone.
About Rosetta Cancer Testing Services
Rosetta Cancer Tests are a series of microRNA-based diagnostic
testing services offered by Rosetta Genomics. The Rosetta Cancer
Origin Test™ can accurately identify the primary tumor type in
primary and metastatic cancer including cancer of unknown or
uncertain primary (CUP). The Rosetta Lung Cancer Test™ accurately
identifies the four main subtypes of lung cancer using small
amounts of tumor cells. The Rosetta Kidney Cancer Test™ accurately
classifies the four most common kidney tumors: clear cell renal
cell carcinoma (RCC), papillary RCC, chromophobe RCC and
oncocytoma. Rosetta’s assays are designed to provide objective
diagnostic data; it is the treating physician’s responsibility to
diagnose and administer the appropriate treatment. In the U.S.
alone, Rosetta Genomics estimates that 200,000 patients a year may
benefit from the Rosetta Cancer Origin Test™, 65,000 from the
Rosetta Kidney Cancer Test™ and 226,000 patients from the Rosetta
Lung Cancer Test™. The Company’s assays are offered directly by
Rosetta Genomics in the U.S., and through distributors around the
world. In addition to its proprietary products, the Company markets
the Rosetta Genomics PGxOne™ test and the EGFR and KRAS sequencing
services for Admera Health, as well as Precipio’s oncology tests,
which include bone marrow and peripheral blood testing for
hematological malignancies, such as leukemias and lymphomas. For
more information, please visit www.rosettagenomics.com. Parties
interested in ordering these tests can contact Rosetta Genomics at
(215) 382-9000 ext. 309.
About Rosetta Genomics
Rosetta develops and commercializes a full range of
microRNA-based molecular diagnostics. Founded in 2000, 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. The Company also
leverages its commercial infrastructure by marketing tests and
sequencing services for Admera Health and Precipio. Rosetta’s
cancer testing services are commercially available through its
Philadelphia-based CAP-accredited, CLIA-certified lab.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future
expectations, plans and prospects, including without limitation,
statements that the patent allowance will provide core protection
for the Rosetta Kidney Cancer Test and statements relating to the
benefits of the Rosetta Kidney Cancer Test, 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.
1 Asnis-Alibozek AG, Fine MJ, Russo P, McLaughlin T, Farrelly
EM, LaFrance N, Lowrance W. Cost of care for malignant and benign
renal masses. AJMC 2013: 19(8) 617-24. [PMID: 24304211]
Company:Rosetta GenomicsKen Berlin, 609-419-9003President
& CEOinvestors@rosettagenomics.comorInvestor:LHAAnne
Marie Fields, 212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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