On June 1, 2019 Veracyte, Inc. (Nasdaq: VCYT) reported new data demonstrating the potential for its Afirma Xpression Atlas (XA) genomic test to guide targeted treatment selection for patients with a rare but aggressive form of thyroid cancer concurrent with diagnosis by the company’s Afirma Genomic Sequencing Classifier (GSC) (Press release, Veracyte, JUN 1, 2019, View Source [SID1234536766]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The findings advance physicians’ ability to answer multiple clinical questions for their thyroid patients using a single, minimally invasive sample. They were presented today at the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) Annual Meeting, which is being held May 31-June 4, 2019 in Chicago.

Researchers used the Afirma XA to conduct RNA sequencing on 90 thyroid fine needle aspiration samples that had been diagnosed with medullary thyroid cancer (MTC) through the Afirma GSC. The cohort was derived from nearly 30,000 sequential samples that were indeterminate or suspicious for cancer following traditional cytopathology testing. The researchers found that the Afirma XA identified a gene variant or fusion in 74 percent of the MTC cases and that 99 percent of these cases had one or more variants or fusions – RET, KRAS, HRAS and/or BRAF alterations – that are targeted by new therapies that are currently in clinical trials or early stage development.

"With the emergence of new molecularly targeted therapies for medullary thyroid cancer, molecular testing to identify the driver genomic mutations will be key to optimizing patient outcomes," said Lori J. Wirth, M.D., medical director of the Center for Head and Neck Cancers at Massachusetts General Hospital, who presented the findings in a poster session today. "The potential to select targeted therapy at the time of diagnosis may be especially helpful for patients with advanced disease."

The Afirma GSC and Xpression Atlas provide physicians with a comprehensive solution for a complex landscape in thyroid nodule diagnosis and individualization of care. Veracyte developed the Afirma GSC with RNA whole-transcriptome sequencing and machine learning. The test helps identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to help patients avoid unnecessary diagnostic thyroid surgery, while also identifying patients with MTC. The Afirma XA provides physicians with genomic alteration content from the same fine needle aspiration samples that are used in Afirma GSC testing and may help physicians decide with greater confidence on the surgical or therapeutic pathway for their patients. The Afirma XA includes 761 DNA variants and 130 RNA fusion partners in over 500 genes that are associated with thyroid cancer.

"These new data show that our comprehensive Afirma solution can not only help patients avoid unnecessary diagnostic surgery when their nodules are benign, but may also inform targeted therapy selection when thyroid cancer is diagnosed," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "These findings represent a significant step forward in delivering on the promise of precision medicine for thyroid cancer patients."

About Thyroid Cancer

The American Cancer Society estimates that 54,070 people in the United States will be diagnosed with thyroid cancer this year. Medullary thyroid cancer, which is more difficult to find and treat, makes up approximately 4 percent of all thyroid cancers. Each year in the United States approximately 525,000 patients undergo FNA biopsies to evaluate thyroid nodules for cancer. Up to 30 percent of these patients receive indeterminate results – meaning they are not clearly benign or malignant – and, historically, most were directed to diagnostic surgery even though 70 percent to 80 percent of the time the nodules ultimately proved to be benign.