Rosetta Genomics and Moffitt Cancer Center will develop microRNA-based cancer diagnostic

Rosetta Genomics Ltd., a developer and provider of microRNA-based molecular diagnostics and therapeutics, has announced that the company has entered into an agreement with Tampa, FL-based Moffitt Cancer Center to advance the development and commercialization of Rosetta's thyroid neoplasia assay. Under the agreement, Rosetta will work with Marino Leon, MD, associate member of the Department of Anatomic Pathology at Moffitt.

An estimated 4% to 7% of the general population develops nodules in the thyroid that can be felt on examination, though fewer than 10% are malignant. A fine needle aspiration (FNA), a non-surgical procedure used to obtain tissue for analysis by a pathologist, is the standard technique for detecting cancer. It is estimated that nearly 500,000 FNAs are performed each year in the United States. Interpretation of FNA samples is not always conclusive, and up to 30% of samples have indeterminate results.

“This agreement is a significant step forward in the development of our key pipeline project, an assay for the differential diagnosis of indeterminate thyroid FNAs. We believe that working with Dr. Leon and others at Moffitt will significantly enhance and accelerate the development of our thyroid neoplasia assay,” states Kenneth A. Berlin, Rosetta Genomics President and CEO. “Results from our initial studies demonstrated that microRNA expression levels can differentiate malignant nodules from benign nodules, and also demonstrated our ability to extract and profile microRNAs from thyroid FNAs in various sample types and in a way consistent with common clinical practices.” Rosetta hopes to launch the assay before the end of 2015.

“Many patients with indeterminate thyroid FNA results are sent to surgery as a precaution, despite the fact that the majority of these cases are benign. This exposes patients to unnecessary surgical risk and costs the system hundreds of millions of dollars,” notes Dr. Leon. “Rosetta is developing a thyroid neoplasia assay that has the potential to improve clinical management in a cost-effective manner by reducing the number of unnecessary surgeries.” Learn more about testing services offered by Rosetta Genomics.