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Rosetta Kidney Cancer Test Gets Final NYS Approval

NEW YORK (GenomeWeb) — Rosetta Genomics said today that it has received final approval from the New York State Department of Health for use of its Rosetta Kidney Cancer Test on patient samples from the state.

Rosetta Genomics has been offering its Kidney Cancer Test in New York under conditional approval since December and now has full approval in all 50 US states.

The Kidney Cancer Test is a microRNA-based assay that can classify the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC, and oncocytoma. Rosetta said that the assay's performance was evaluated using a blinded independent validation set of 200 samples. Of the 184 samples that produced a result, 174 were classified correctly demonstrating 95 percent sensitivity with 98 percent specificity.

According to Rosetta, there are approximately 65,000 new cases of primary kidney tumors and 13,000 deaths per year in the US, and incidence is rising. Nearly a quarter 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 to 10 percent of patients have a pre-operative biopsy." Rosetta CEO Kenneth Berlin said in a statement. "We believe there is an opportunity to improve the standard of care in this setting through the use of our assay."