Rosetta Genomics Announces Final New York State Approval for Rosetta Kidney Cancer Test
Rosetta Genomics Ltd. (NASDAQ: ROSG), a leading developer and
provider of microRNA-based molecular diagnostics and therapeutics,
announced that the New York State Department of Health ("NYSDOH") has
given the Company final approval for its Rosetta Kidney Cancer Testâ„¢
for testing on patient samples from the State. New York is the only
U.S. state that requires an independent regulatory review process for
laboratory-developed tests. Rosetta Genomics has been offering its
Kidney Cancer Test in New York under conditional approval since
December 9, 2013 and now has full approval in all 50 U.S. states. The
Kidney Cancer Test is the Company's proprietary microRNA-based assay
that can classify the four most common kidney tumors: Clear Cell
Renal Cell Carcinoma (RCC), Papillary RCC, Chromophobe RCC and
Oncocytoma. With this final approval, each of Rosetta's cancer
testing services now has full New York State approval.
A blinded independent validation set of 200 samples was studied to
measure the performance of the Rosetta Kidney Cancer Test. Of the 184
samples that produced a result, 174 were classified correctly
demonstrating 95% accuracy or sensitivity, with 98% specificity.
"There are approximately 65,000 new cases of primary kidney tumors
and 13,000 deaths per year in the United States, and the incidence is
rising. Unfortunately, nearly 25% of patients who have a kidney
removed for presumptive RCC, turn out to have benign oncocytomas,
which are safely monitored without nephrectomy. This failure of
pre-operative diagnosis is in part the result of the small number of
pre-operative biopsies, as only about 9-10% of patients have a
pre-operative biopsy. We believe there is an opportunity to improve
the standard-of-care in this setting through the use of our assay,"
said Kenneth A. Berlin, President and Chief Executive Officer of
"Differential diagnosis between various types of kidney tumors
remains challenging and can lead not only to unnecessary surgeries,
but also the introduction of new, molecularly-targeted therapeutics
makes the correct identification of these subtypes critically
important for treatment choice and for patient selection for clinical
trials of new therapeutics in development. With a sensitivity of 95%
and a specificity of 98%, we are confident this assay can be a useful
tool for pathologists and oncologists and we are very pleased to have
final approval to market this important cancer diagnostic for the
benefit of physicians and patients in New York," concluded Mr.
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