Rosetta Genomics, a provider of microRNA-based molecular diagnostics, has obtained a conditional approval from the New York State Department of Health (NYSDOH) for its Rosetta Kidney Cancer Test for testing on patient samples from the state.
This approval allows the company to offer its Rosetta Kidney Cancer Test in all 50 US states. In making the assay available pending final approval, the NYSDOH requires Rosetta Genomics to provide any additional information the department requests within 60 business days.
Rosetta Kidney Cancer Test is a microRNA-based assay which accurately classifies the four most common kidney tumors, including clear cell renal cell carcinoma (RCC), papillary RCC, chromophobe RCC and the benign oncocytoma.
Rosetta Genomics president and CEO Kenneth A Berlin noted the Rosetta Kidney Cancer Test, with its high level of accuracy, can be an important aid to physicians to ensure that the right medical intervention is given to the right patient at the right time, which is what personalized medicine is all about.
"With sensitivity and specificity in excess of 95%, we believe this assay is a useful tool for physicians and we are very pleased to have approval to market this important cancer diagnostic for the benefit of patients in New York.
"In order to increase awareness of and demand for the Kidney Cancer Test we have recently provided training to our sales team and will be launching key supporting marketing initiatives, including new promotional materials, web-based programs and telemarketing campaigns," Berlin added.
Rosetta Kidney Cancer Test is one of four assays Rosetta Genomics is currently selling through its CLIA-lab in Philadelphia, Pennsylvania.