Global Health Care Group

ThyroSeq®

Detailed Product Description

ThyroSeq® Genomic Classifier (GC) is a test for the pre-operative assessment of thyroid nodules with indeterminate cytology, which offers accurate assessment of cancer probability in a given nodule and additionally provides information on cancer prognostication, helping to select the most optimal patient management.

ThyroSeq incorporates all major scientific advances in thyroid cancer genetics and has more than 10-years' experience serving physicians and their patients with thyroid nodules and cancer. The first version of ThyroSeq was launched for clinical use at the University of Pittsburgh Medical Center as a seven-gene panel (ThyroSeq v0) in April of 2007. Until recently, the test was offered as ThyroSeq v2. Today, ThyroSeq v3 is available for clinical use.

SO YOU HAVE A THYROID NODULE AND CYTOLOGY RESULTS ARE INDETERMINATE.

Your doctor will need to determine what type of thyroid nodule you have, which will direct the most appropriate course of treatment. For those nodules that are large or have suspicious ultrasound features, a Fine Needle Aspiration (FNA) biopsy is frequently performed to diagnose the nodule. The FNA biopsy is sent to a doctor called a cytopathologist, who is specially trained to diagnose disease by examining your body’s cells under a microscope. The cytopathologist will provide a definitive diagnosis of benign (not cancer) or malignant (cancer) in most cases. In about 20-30% of nodules, the cytopathologist cannot reliably exclude cancer and such cases are placed in an indeterminate cytology category. Before molecular testing, most people with indeterminate cytology results had to have surgery to take out the part of the thyroid with the nodule, to determine if it was cancerous. About 80% of the time, the nodule would be benign, which meant that the majority of people had potentially unnecessary surgery. For some of the remaining 20% of patients where cancer was found, a second surgery or completion thyroidectomy was needed. Therefore, most of the patients with indeterminate cytology results had unnecessary surgery on benign nodules and some of the patients with cancer received inadequate surgery with their first procedure.

HOW CAN THYROSEQ HELP?

ThyroSeq is a molecular test specifically designed to help determine if a nodule is benign or malignant, whenever cytology results are indeterminate. Your doctor will review the results with you to determine a personalized course of treatment, specific to your results and personal medical history. If your ThyroSeq result comes back negative, you can likely avoid surgical removal of your thyroid. If the result is positive, ThyroSeq provides additional information to help you and your doctor decide on the most appropriate surgery, which may include preserving part of your thyroid and protecting your natural thyroid function.

HOW DOES THYROSEQ WORK?

ThyroSeq uses cutting-edge Next-Generation Sequencing technology to identify unique genetic alterations in your thyroid nodule to help determine if your nodule is benign or malignant. ThyroSeq uses cells collected during your FNA biopsy procedure and obtains information on hundreds of gene regions in one tube. Pathologists interpret genetic alterations found to determine the risk of cancer in your thyroid nodule. ThyroSeq results, when combined with your cytology diagnosis and thyroid nodule imaging, help your doctor personalize the management of your thyroid nodule. ThyroSeq was designed by expert physicians in the field of thyroid cancer and combines years of scientific and clinical experience to help you and your doctor personalize your care.

HOW CAN I GET THYROSEQ TESTING?

Talk to your doctor about ThyroSeq testing. ThyroSeq testing is performed on an FNA pass which can be completed during your initial FNA procedure or can be performed after, if cytology results are indeterminate.

HOW LONG DOES IT TAKE TO GET RESULTS?

It usually takes 7-10 business days to receive ThyroSeq results after receipt of sample to the lab.