Rosetta Genomics's RosettaGX Reveal, a molecular test for thyroid patients, was recently approved in New York, making the test available in all 50 states.
“We are very pleased to have final approval for this important cancer diagnostic for the benefit of physicians and patients in New York State,” Kenneth A. Berlin, president and CEO of Rosetta Genomics, said in a press release. “The NYSDOH has a very rigorous approval process and this final approval further confirms the overall robust performance of our Reveal assay.”
With Reveal, Berlin said that the number of thyroid surgeries will be severely reduced, which cost health companies and patients a lot of money.
“It is estimated that nearly 550,000 FNAs are performed on thyroid nodules each year in the U.S. and that approximately 740,000 are performed annually in Europe,” he said.
Even though many patients have surgery for this, sometimes they are not cancerous, which doesn’t require surgery to fix.
“This exposes patients to unnecessary surgical risk and costs the healthcare system hundreds of millions of dollars,” Berlin said. “Through an analysis of our validation study data, we believe we can help prevent up to 75% of unnecessary thyroid surgeries.”