SOUTH SAN FRANCISCO, Calif., Oct. 21, 2015 /PRNewswire/ -- Veracyte, Inc. (NASDAQ: VCYT), a molecular diagnostics company pioneering the field of molecular cytology, today announced findings from a new study of the largest panel of thyroid cancer-associated gene alterations to date. The results showed that well-established and more recently discovered molecular alterations that are associated with thyroid cancer were found in both confirmed benign and malignant nodules. This suggests that more research is needed to understand how gene variant and fusion information can best be used to guide physician decision-making in thyroid cancer diagnosis. The findings were presented today at the 15th Annual International Thyroid Congress (ITC) and 85th Annual Meeting of the American Thyroid Association (ATA), in Lake Buena Vista, Fla.
Veracyte researchers developed a test panel of 851 variants and 133 fusions in 524 genes, based on known gene alterations associated with thyroid cancer, including those identified by The Cancer Genome Atlas (TCGA) project.* They then used RNA sequencing to determine the presence of these gene alterations in 76 malignant thyroid samples, representing a variety of cancer subtypes, and in 75 benign samples. Consistent with other studies on DNA-based mutations, the researchers found that gene alterations appeared in only 50 percent of the cancerous samples (sensitivity). At the same time, 20 percent of the benign thyroid samples harbored gene alterations (i.e., 80 percent specificity).
"As gene alterations associated with thyroid cancer become more common in the literature, physicians are increasingly interested in how to use this information in clinical practice," said Richard Kloos, M.D., Veracyte's senior medical director, endocrinology, who presented the data. "Our findings suggest that caution should be exercised, particularly in using gene variant and fusion panels on their own to rule out or rule in cancer in thyroid nodule patients.
"Our results also underscore the tremendous need to clarify the role that gene alterations can potentially play in thyroid cancer diagnosis. We look forward to pursuing this question more fully and to exploring how gene variant and fusion data, based on powerful RNA sequencing, could potentially be used with our Afirma® Gene Expression Classifier (GEC) to extract additional, clinically useful information from thyroid nodule samples."
Veracyte's Afirma GEC uses RNA-based gene expression and is proven in rigorous clinical studies to identify benign thyroid nodules among those deemed indeterminate by cytopathology, enabling these patients to potentially avoid an unnecessary surgery. The company's Afirma Malignancy Classifiers - comprising tests for medullary thyroid cancer and BRAF gene mutation status - are designed to inform surgical strategy for those patients headed to surgery based on their cytopathology or Afirma GEC results.
For the study presented today, Veracyte researchers evaluated the presence of gene variants and fusions using RNA sequencing, which measured gene alterations found only in genes expressed in thyroid nodules. "We believe RNA sequencing offers a potentially powerful approach to evaluating gene variants and fusions because it looks at biological activity associated with these gene alterations, which may be more indicative of disease processes, compared to DNA-based gene alterations, which may never be expressed in the tissue of interest. We continue to evaluate the impact of this richer genomic information in enhancing physician-patient decision making," said Dr. Kloos.
Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte's Afirma® Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier (GEC) and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for approximately 150 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta™ Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. Veracyte is developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.
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* The Cancer Genome Atlas (TCGA) is a collaboration between the National Cancer Institute (NCI) and National Human Genome Research Institute (NHGRI) that aims to generate comprehensive, multi-dimensional maps of the key genomic changes in major types and subtypes of cancer.