Clinician Survey Supporting Value Proposition of the Rosetta Kidney Cancer Test™ Published in the Journal of Kidney Cancer
January 20 2015 - 8:00AM
Business Wire
Article Highlights Receptivity to a novel
microRNA Diagnostic to Reduce Unnecessary Surgery for Kidney
Tumors
Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and
provider of microRNA-based molecular diagnostics, announces the
publication of an article in the Journal of Kidney Cancer in
support of the use of the Rosetta Kidney Cancer Test™. Titled
“Clinicians’ Real World Perceptions of Pre-Nephrectomy Diagnostic
Biopsy Performance as a Driver of Reduction in Unnecessary
Surgeries in Renal Tumors,” the article appeared in the online
edition on January 18, 2015 and can be accessed here.
MedPanel, LLC, a research organization based in Cambridge, Mass.
with extensive reach among healthcare professionals within
community and academic medical centers, developed and conducted a
survey of 102 practicing urologists and pathologists. The study was
designed to understand the perceived needs for better diagnosis in
renal tumors and the potential impact of a new biomarker test
developed by Rosetta Genomics with previously demonstrated
performance characteristics. Participating physicians were blinded
throughout the research as to the identity and source of the
specific test, and to the study sponsor.
According to the study results, treatment decisions today are
clearly influenced by histological subtype, which too often is not
available prior to surgery or is inaccurate. Nearly all surveyed
urologists (94%) believe it is important to avoid resecting a
benign tumor. In un-typed tumors, later determined to be renal
oncocytoma (RO) after resection, they would not have resected the
tumor in 59% of cases if they had an accurate diagnosis in advance.
Urologists also reported they would use a tool that could more
accurately classify tumor subtype in 62% of cases, and 73% believe
the performance characteristics matching the Rosetta Kidney Cancer
Test’s performance provide sufficiently meaningful results to
change treatment of RO patients. They specifically expect cases
where they would not perform a resection due to diagnosis of RO to
increase by nearly two-thirds, and cases where they would perform a
partial instead of a total nephrectomy to increase by approximately
50%.
The Rosetta Kidney Cancer Test™ is able to differentiate between
renal cell carcinoma (RCC) and RO, which are two of the four most
common kidney tumors. The test also accurately classifies papillary
RCC and chromophobe RCC.
RO, which is the most common benign tumor of the kidney, should
be managed by monitoring and expectant treatment rather than by
total nephrectomy. Unfortunately, because of the similarity in
radiological and histological appearance, RO is oftentimes
misdiagnosed as RCC, which is a malignant tumor. The infrequent use
of pre-nephrectomy biopsies is a function of historical limitations
of histopathological differential diagnosis in this setting.
The impact of the limitation of diagnostic capability in RO 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 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 RCC 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.
“We are very pleased with the publication of this survey in a
peer-reviewed journal that is specifically tailored to kidney
cancer specialists,” noted Kenneth A. Berlin, President and Chief
Executive Officer of Rosetta Genomics. “Clinician receptivity to
improved diagnostic technology to change their practice and
increase use of pre-nephrectomy biopsy to reduce unnecessary
surgery is a critical first step to improve care and lower
healthcare costs. The results of this survey should significantly
enhance our efforts to make pre-nephrectomy biopsy and differential
diagnosis with the Rosetta Kidney Cancer Test™ a standard practice
in kidney cancer diagnosis and treatment, and should resonate in
important ways with payers in support of coverage for our
test.”
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. For more information, please visit www.rosettagenomics.com.
Parties interested in ordering the test can contact Rosetta
Genomics at (215) 382-9000.
About Rosetta Genomics
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 and therapeutics. Rosetta currently commercializes a full
range of microRNA-based molecular diagnostics. Rosetta’s cancer
testing services are commercially available through its
Philadelphia-based CAP-accredited, CLIA-certified lab. For more
information, please visit www.rosettagenomics.com.
Forward-Looking Statement Disclaimer
Various statements in this release concerning Rosetta’s future
expectations, plans and prospects, including without limitation,
statements that improved diagnostic technology can change
clinician's practice and increase use of pre-nephrectomy biopsy,
Rosetta Kidney Cancer Test™ becoming a standard practice in kidney
cancer diagnosis and treatment and Rosetta receiving coverage for
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, 2013 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]
Rosetta Genomics:Ken Berlin, 609-419-9003President &
CEOinvestors@rosettagenomics.comorRosetta Genomics
Investor:LHAAnne Marie Fields,
212-838-3777afields@lhai.comorBruce Voss,
310-691-7100bvoss@lhai.com
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