Rosetta Genomics Receives Final New York State Approval
News Jul 26, 2014
Rosetta Genomics Ltd. has announced that the New York State Department of Health ("NYSDOH") has given the Company final approval for its Rosetta Kidney Cancer Test™ 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 Rosetta Genomics.
"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. Berlin.
As genome editing technologies advance toward clinical therapies, they are raising hopes of a completely new way to treat disease. However, challenges need to be addressed before potential treatments can be widely used in patients. To tackle these challenges, the National Institutes of Health has launched the Somatic Cell Genome Editing program, which has awarded multiple grants including more than $3.6 million to assess the safety of genome editing in human cells and tissues.