The New York State Department of Health (NYSDOH) has granted conditional approval for in-state use of a kidney cancer test from Rosetta Genomics to examine patient samples. Since New York is the only state requiring independent regulatory review for laboratory-developed tests, the NYSDOH approval permits the assay to be offered in all 50 states pending final approval. For final approval, Rosetta must provide any additional information the NYSDOH requests within 60 days.
The microRNA-based assay classifies the four most common kidney tumors: clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC, and benign oncocytoma.
“The incidence of primary kidney tumors is rising, and differential diagnosis between various types of kidney tumors remains challenging at times,” said E. Robert Wassman, MD, chief medical officer for Rosetta Genomics. “One diagnostic challenge, often underestimated, is clearly differentiating between oncocytomas, now considered benign and appropriate to watch without intervention, and subtypes of RCC, particularly chromophobe RCC, where their malignant nature dictates prompt intervention.”
According to the American Cancer Association, kidney cancer is among the 10 most common cancers in the United States. The disease was responsible for approximately 14,000 U.S. deaths in 2013 alone.
Click here to read the full release.
