FDAnews Device Daily Bulletin
Medical Devices / Submissions and Approvals

Rosetta Genomics Wins Full N.Y. Approval for Kidney Cancer Test

July 23, 2014

Molecular diagnostics maker Rosetta Genomics said Tuesday that its Rosetta Kidney Cancer Test has received a thumbs up from the New York State Department of Health for testing on patient samples.

New York is the only state that requires an independent regulatory review process for laboratory-developed tests, and the Rosetta test has been offered there under conditional approval since December 2013. The final approval means the test is now fully available in every state in the U.S.

According to Rosetta, its exclusive, microRNA-based assay can identify the four most common kidney tumors: clear cell renal cell carcinoma, papillary RCC, chromophobe RCC and oncocytoma. In a study of 200 samples to measure the test’s performance, 184 produced a result and 174 of those classified the type of tumor correctly. That translates to 95 percent accuracy and 98 percent specificity, the Rehovot, Israel company says.

There are approximately 65,000 new cases of kidney cancer diagnosed in the U.S. each year and 13,000 deaths, says Kenneth Berlin, Rosetta’s president and CEO. However, 25 percent of kidneys that are removed as cancerous turn out to have benign oncocytomas, which are safely monitored without nephrectomy, he says. With better diagnostics and more preoperative biopsies, patients with oncocytomas could be spared needless kidney removal, he adds. — Kellen Owings

Subscribe to Devices & Diagnostics Letter for complete coverage of the medical devices industry. Click here for more information.