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ThyroSeq Announces Results of Large Multi-Center Study Validating New ThyroSeq V3 Test at the American Thyroid Association Meeting in Victoria, BC, Canada

STUDY DEMONSTRATES HIGHLY ACCURATE PERFORMANCE OF THE TEST ALLOWING TO AVOID THE LARGEST NUMBER OF DIAGNOSTIC THYROID SURGERIES

10/23/2017

NEW YORK, Oct. 23, 2017 /PRNewswire/ -- ThyroSeq® presented the results of its prospective, double-blind, multi-center international study today, at the 87th Annual Meeting of the American Thyroid Association (ATA) in Victoria, BC, Canada. The results of the study provided clinical validation of the performance of ThyroSeq V3® in thyroid nodules with indeterminate cytology. A clinical oral presentation and a poster presentation demonstrated that ThyroSeq's V3 is an effective tool for a definitive diagnosis that can help to prevent the largest number of diagnostic thyroid surgeries for patients with thyroid nodules, thus providing the most cost-effective patient care.

"These exciting findings have been rigorously validated in multiple clinical centers in the U.S. and abroad," said Yuri Nikiforov, M.D., Ph.D., Professor of Pathology at University of Pittsburgh Medical Center, and principal investigator of the multi-center ThyroSeq V3 trial. "Every indication is that based on the cutting-edge genomic science we'll be able to avoid surgery for more than 60% of patients with thyroid nodules that had indeterminate cytology and offer more effective, individualized management for those patients that likely have cancerous thyroid nodules."  

The study shows that ThyroSeq V3 provides reliable performance across various types of cancerous and benign thyroid nodules and in populations with variable disease prevalence, making it a robust tool for clinical use.

Key findings of the study include:

  • ThyroSeq V3 has both very high sensitivity and high specificity and therefore can be used as a "rule-out" and "rule-in" test for cancer in thyroid nodules.
  • ThyroSeq V3 implementation into clinical practice can lead to avoiding surgery for more than 60% of patients with thyroid nodules that had indeterminate cytology.
  • ThyroSeq V3 provides additional valuable prognostic information, informing the most optimal, personalized surgery for cancerous nodules.
  • ThyroSeq V3 offers all of the benefits of V2 and expands them further with a larger gene panel and its validation in a prospective, blinded, multicenter study.

 

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