Veracyte Announces Data from Seven Afirma® Gene Expression Classifier Studies to Be Presented at the 86th Annual Meeting of the American Thyroid Association

SOUTH SAN FRANCISCO, Calif., Sept. 15, 2016 /PRNewswire/ -- Veracyte, Inc. (NASDAQ: VCYT) today announced that external researchers will present six posters that reinforce the role of the Afirma Gene Expression Classifier (GEC) as a new standard of care in thyroid cancer diagnosis at the 86^th Annual Meeting of the American Thyroid Association (ATA), being held September 21-25 in Denver. Company scientists will also present data suggesting the potential to further enhance the Afirma GEC's performance by combining the test's proven RNA expression-based capabilities with gene variant and fusion information on a next-generation sequencing (NGS) platform.

"Addressing over-treatment of thyroid cancer is a top priority in this field," said Bonnie Anderson, Veracyte's president and chief executive officer. "The long-term clinical evidence presented at the ATA conference will demonstrate the Afirma GEC's efficacy in helping patients with thyroid nodules avoid surgery they do not need, preserving the critical functions of the thyroid gland and taking costs out of the healthcare system. Additionally, our clinical research program continues to push the limits of what is possible in the diagnosis of thyroid cancer through advances that combine rich RNA sequencing with our core machine-learning technology expertise."

To date, Veracyte has received more than 270,000 fine needle aspiration (FNA) patient samples and has performed over 60,000 Afirma GEC tests on those deemed inconclusive by cytopathology. The genomic test is supported by more than 20 published studies and is included in all of the leading clinical practice guidelines. The Afirma GEC is covered by Medicare and most leading private insurance companies, which collectively represent approximately 185 million Americans.

The following abstracts will be presented during the General Poster Session in the Exhibit Hall of the Sheraton Denver Downtown Hotel:

More information about Veracyte's participation at the ATA conference can be found at www.afirma.com/ata2016.

About Afirma
Among the approximately 525,000 patients who undergo an FNA procedure each year to evaluate potentially cancerous thyroid nodules, up to 30 percent of results are inconclusive. Historically, most of these patients have been directed to surgery for a more definitive diagnosis. The Afirma GEC is proven to identify, with a high degree of accuracy (negative predictive value of >94 percent), patients whose thyroid nodules are benign so that they may be monitored in lieu of diagnostic surgery. The genomic test is the core component of Veracyte's Afirma Thyroid FNA Analysis, a comprehensive solution for improved thyroid nodule assessment. 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. 

About Veracyte 
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 180 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 2015, the company launched the Percepta^® Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer, which has already received draft Medicare coverage. In the fourth quarter of 2016, Veracyte plans to launch its second pulmonology product, the Envisia™ classifier, to improve diagnosis of interstitial lung diseases including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.

Cautionary Note Regarding Forward-Looking Statements 
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "may," "will" and similar references to future periods. Examples of forward-looking statements include, among others, statements we make regarding our beliefs regarding the drivers of adoption of Afirma, our expectations with respect to the success of our entry into the pulmonology market, our expectations regarding full-year 2016 guidance and forecast for annual GEC test volume, and the value and potential of our technology and research and development pipeline. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they are based only on our current beliefs, expectations and assumptions regarding the future of our business, future plans and strategies, anticipated events and trends, the economy and other future conditions. Forward-looking statements involve risks and uncertainties, which could cause actual results to differ materially, and reported results should not be considered as an indication of future performance. These risks and uncertainties include, but are not limited to: our limited operating history and history of losses; our ability to increase usage of and reimbursement for Afirma and to obtain reimbursement for any future products we may develop or sell; our ability to continue our momentum and growth; our dependence on a few payers for a significant portion of our revenue; the complexity, time and expense associated with billing and collecting from payers for our tests; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our dependence on strategic relationships and our ability to successfully convert new accounts resulting from such relationships; our ability to develop and commercialize new products and the timing of commercialization; the size of the market opportunity for our Percepta Bronchial Genomic Classifier; our ability to successfully achieve adoption of and reimbursement for our Percepta Bronchial Genomic Classifier; the amount the use of the Percepta Bronchial Genomic Classifier is able to reduce invasive procedures and reduce healthcare costs; our ability to achieve sales penetration in complex commercial accounts; the occurrence and outcome of clinical studies; the timing and publication of study results; the applicability of clinical results to actual outcomes; our inclusion in clinical practice guidelines; the continued application of clinical guidelines to our products; our ability to compete; our ability to obtain capital when needed; and other risks set forth in the company's filings with the Securities and Exchange Commission, including the risks set forth in the company's Quarterly Report on Form 10-Q for the quarter ended June 30, 2016. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.

Veracyte, Afirma, Percepta, Envisia, the Veracyte logo, and the Afirma logo are trademarks of Veracyte, Inc.

SOURCE Veracyte

Related Links

http://www.veracyte.com