Veracyte presents positive data from three Afirma studies
July 26, 2017 – SOUTH SAN FRANCISCO. Veracyte, Inc. announced that an oral presentation of data from the pivotal clinical validation study of the company’s next-generation Afirma Genomic Sequencing Classifier (GSC) will be presented at the 3rd World Congress on Thyroid Cancer (WCTC). Additionally, positive data from two clinical utility studies evaluating the company’s flagship Afirma Gene Expression Classifier (GEC) will be presented as posters at the meeting, being held July 27-30 in Boston, Mass.
“Our Afirma GEC has set a new standard of care in thyroid cancer diagnosis, with more than 25 peer-reviewed, published studies demonstrating its performance and clinical utility, and coverage by all leading U.S. health insurers,” said Bonnie Anderson, Veracyte’s chief executive officer and chairman. “Our next-generation Afirma GSC reflects our commitment to scientific and clinical rigor and, we believe, will help save significantly more patients from unnecessary thyroid surgery.”
In the oral presentation, Kepal Patel, M.D., will share study findings that validate the performance of the Afirma GSC in a prospective, multicenter, blinded cohort of 191 indeterminate thyroid nodule fine needle aspiration samples – the same sample set used previously to validate the first-generation Afirma classifier.
Panjali Sharma, M.D., will present data that reinforce the ability of the Afirma GEC to better ensure that patients with indeterminate thyroid nodules who undergo diagnostic surgery actually have cancer, compared to the traditional practice of most patients with indeterminate nodules being directed to surgery. The findings are from a study of Afirma testing at a community thyroid center over a four-year period. Details of the presentation are as follows:
R. Mack Harrell, M.D., will present data confirming the Afirma GEC’s low false-negative rate, even in an endocrine surgery practice with high rates of cancer in its Afirma-tested patient population. The study evaluated Afirma results over a six-year period.
The Afirma Genomic Sequencing Classifier is the next-generation version of the Afirma Gene Expression Classifier, and is used to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to preserve the thyroid. Each year in the United States, more than 525,000 fine needle aspiration biopsies are performed to assess patients with potentially cancerous thyroid nodules. Up to 30 percent of the results are indeterminate (not clearly benign or malignant) and physicians have traditionally recommended thyroid surgery for a more definitive diagnosis. Following surgery, however, 70 to 80 percent of patients’ nodules are diagnosed as benign, meaning the surgery was unnecessary. Such surgery is invasive, costly and often leads to the need for lifelong daily thyroid hormone replacement drugs.
SOURCE: Veracyte, Inc.