Rosetta Genomics’ Novel and Differentiated Thyroid Cancer Assay Moves to Advanced Stages of Development
February 26 2015 - 8:25AM
Business Wire
Company remains on track to launch the novel
assay by the end of the third quarter of 2015
Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and
provider of microRNA-based molecular diagnostics, provides an
update on the development of its microRNA-based assay for the
differential diagnosis of thyroid neoplasia, which has the
potential to improve clinical management in a cost-effective manner
by reducing the number of unnecessary surgeries.
An estimated 4% to 7% of the general population develops nodules
in the thyroid that can be felt upon examination, although fewer
than 10% are malignant. A Fine Needle Aspirate (FNA) to obtain
tissue from the thyroid nodule for analysis is the standard
technique for detecting cancer. It is estimated that nearly 500,000
FNAs are performed each year in the U.S. and approximately 740,000
are performed annually in Europe. Interpretation of FNA samples is
not always straightforward, leading to an indeterminate result in
up to 30% of the samples. Approximately 75% of patients with
indeterminate results undergo surgery - despite the fact that less
than 50% of these tumors are malignant. This exposes patients to
unnecessary surgical risk and costs hundreds of millions of
dollars.
Rosetta Genomics has been developing this assay for the past two
years and has conducted several discovery studies with more than
500 thyroid FNA and surgical samples, representing various
histological subtypes. The samples were analyzed using the
Company’s proprietary microarray and qPCR platforms, and a subset
of the samples was also analyzed by deep sequencing. This approach
enabled the discovery of new microRNA biomarkers and allows the
profiling of small cytological samples to ensure low failure
rates.
Several microRNAs differentially expressed between benign and
malignant tumors, as well as microRNA biomarkers of medullary
thyroid carcinoma, one of the deadliest forms of thyroid cancer,
were identified in these studies. These studies also demonstrated
the ability to extract and profile microRNAs from thyroid FNAs in
various sample types, such as cytological smears and cellblocks,
and in a manner that is consistent with common clinical practices.
Rosetta is now conducting training studies and will soon commence
blinded validation studies at several leading medical centers in
Israel, Europe and the U.S., where the Company already has samples
ready for testing.
“We are very pleased with the progress we’ve made in advancing
the development of our thyroid cancer assay. Upon commercialization
we believe our thyroid assay will be competitive with current
testing methods as we expect it to have the best combination of
Negative Predictive Values and Positive Predictive Values, our
turnaround time is expected to be less than half that of the market
leaders and our process will spare patients unnecessary needle
passages. Our specimen collection process is a competitive
differentiator because it can utilize the smear used by the
cytologist as part of their standard process rather than taking
additional FNAs and preserving them in specialized tubes. The
latter process of taking additional FNAs through another needle
passage into the patient’s neck is required by some currently
marketed thyroid tests, also creates the potential for
misdiagnosis,” stated Kenneth A. Berlin, President and Chief
Executive Officer of Rosetta Genomics.
According to Nicole Massoll, M.D., Director of Cytopathology,
University of Arkansas for Medical Sciences, Director of FNApath,
"Rosetta’s soon to be launched thyroid test brings an innovative
new way to help those patients and physicians struggling with an
indeterminate result in thyroid nodules utilizing microRNAs. This
test uses selected slides from the smears with the previously
identified cells in question for molecular testing, while methods
that require a separate FNA may not have the cells of interest
leaving the potential for misdiagnosis.”
“We will soon complete our training and validation studies and
we remain on track to launch our microRNA-based thyroid neoplasia
assay by the end of the third quarter of 2015. We believe this will
be an important product for our portfolio as earlier competitors
have already established the market and such testing has already
been incorporated into the National Comprehensive Cancer Network’s
clinical practice guidelines. In addition, the growing body of
clinical evidence supporting the medical and economic utility of
our thyroid assay has been developed and should support relatively
rapid reimbursement coverage. With nearly 30% of FNAs yielding
indeterminate results, the annual opportunity in the U.S. alone
exceeds $350 million and currently available tests in this space
generated approximately $50 million in revenues in 2014. We are
looking forward to launching our novel and differentiated assay
into this fast converting market,” added Mr. Berlin.
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 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. 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,
the timing in which Rosetta will commence blinded validation
studies, the various aspects of Rosetta’s thyroid assay as well as
Rosetta’s thyroid assay as a whole being competitive with current
testing methods, the scope of sales generated by and the market
opportunity for Rosetta’s thyroid assay, the fact that Rosetta’s
thyroid assay will launch, as well as the timeline for said launch,
Rosetta’s thyroid assay being incorporated in the National
Comprehensive Cancer Network’s clinical practice guidelines,
Rosetta’s thyroid assay receiving reimbursement coverage, Rosetta’s
development or commercialization of molecular diagnostics or
therapeutics, the market acceptance of Rosetta’s cancer testing
services, particularly the Rosetta Cancer Origin Test™ and the
thyroid assay, Rosetta’s development of personalized medicine
products and services, 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.
Rosetta Genomics Ltd.Rosetta GenomicsKen Berlin, President &
CEO609-419-9003investors@rosettagenomics.comInvestor:LHAAnne
Marie Fields212-838-3777afields@lhai.comorBruce
Voss310-691-7100bvoss@lhai.com
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