Studies support use of ThyraMIR and ThyGenX to improve detection of benign/malignant thyroid nodules

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Reviewed

May 18 2015

Data will be presented at both Digestive Disease Week (DDW) and the American Association of Clinical Endocrinologists (AACE) annual medical meetings. Since the two meetings are overlapping we wanted to make sure you have the research being presented together since they are for molecular diagnostic tools from PDI’s subsidiary Interpace Diagnostics. For DDW data is on esophageal cancer, biliary cancer and pancreatic cysts and AACE is on thyroid nodule identification.

Data on two studies show ThyraMIR™, a novel microRNA gene expression classifier combined with ThyGenX™, a genetic mutation panel, provides physicians a unique solution that may potentially result in fewer unnecessary surgeries for patients with previously indeterminate thyroid nodules
Data has also just been published in The Journal of Clinical Endocrinology & Metabolism (JCEM) reinforcing evidence that this combination testing can improve detection of benign/malignant thyroid nodules previously diagnosed as indeterminate, which can lead to much better patient care
These data show that these tests improve preoperative risk-based management of benign thyroid nodules with indeterminate cytology, helping patients get the right surgery the first time, and not unnecessary surgery if they don’t need it.
Approximately 525,000 thyroid nodule fine-needle aspiration (FNA) procedures are performed each year in the US. Up to 35% of thyroid nodules evaluated by FNA and cytopathology don’t yield a definitive benign or malignant diagnosis. In many cases, preoperative molecular testing on indeterminate nodules can aid clinicians in ruling in or ruling out thyroid cancer and reduce the number of unnecessary or suboptimal surgeries.
National Comprehensive Cancer Network (NCCN) and American Thyroid Association (ATA) guidelines currently recommend consideration of molecular testing on these indeterminate cases to help inform treatment decisions and to help avoid unnecessary surgery on benign nodules, which may occur in 70% to 80% of the cases.

POSTER BEING PRESENTED:

Abstract_1086 – May 15, 2015, 9:45 am CST - COMPREHENSIVE DIAGNOSTIC EVALUATION OF NEOPLASTIC THYROID LESIONS BY NEXT GENERATION SEQUENCING AND MIRNA GENE EXPRESSION
Abstract_1095 – May 15, 2015, 9:45 am CST - ACCURATE DETECTION OF ONCOGENIC MUTATIONS IN THYROID NODULE ASPIRATES WITH THE NEXT GENERATION SEQUENCING THYGENX TEST

DDW:

Data will be presented on the clinical value of BarreGen™, a molecular diagnostic test for predicting risk of progression from Barrett’s esophagus to esophageal cancer approximately 3-4 years before the cancer develops.
Barrett’s esophagus is most often diagnosed in people who have long-term gastroesophageal reflux disease (GERD) — a chronic regurgitation of acid from the stomach into the lower esophagus. Barrett’s esophagus incidence ranges from 8-22% in these patients and is rising.
The potential for BarreGen is great and it advances the physician’s ability to identify patients at high risk for developing esophageal cancer years before it occurs. BarreGen demonstrates that this molecular diagnostics test helps differentiate patients at high risk of progression from those at low risk of progression prior to the onset to cancer well before observable changes in the cells. The test also had an overall accuracy of 95 percent in discriminating patients who progressed to cancer from those who did not.

POSTER BEING PRESENTED: