An estimated 4-7 percent of the general population develops nodules in the thyroid that can be felt on examination, though fewer than 10 percent 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 and approximately 740,000 are performed annually in Europe. Interpretation of FNA samples is not always conclusive, and up to 30 percent 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 experts like Dr. Leon and others at Moffitt will significantly enhance and accelerate the development of our thyroid neoplasia assay," stated Kenneth A. Berlin, President and Chief Executive Officer. "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. This agreement with Moffitt will help us further advance the development of this important assay, and should allow us to achieve our goal of launching this important assay prior to the end of 2015."
Under the agreement, Rosetta will work with Marino Leon, M.D., associate member of the Department of Anatomic Pathology at Moffitt.
"Many patients with repeated indeterminate thyroid FNA results are sent to surgery as a precaution, some of these cases are benign lesions. This exposes patients to unnecessary surgical risk and costs the system hundreds of millions of dollars," noted 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. This is in keeping with Moffitt's commitment to support innovations that enhance patient care and outcomes."