Press Release

Veracyte Announces Data from Multiple Studies Advancing Scientific Understanding of Thyroid Cancer to Be Presented at AACE Congress

May 23, 2016

SOUTH SAN FRANCISCO, Calif., May 23, 2016 /PRNewswire/ -- Veracyte, Inc. (NASDAQ: VCYT), a molecular diagnostics company pioneering the field of molecular cytology, today announced that company scientists and external researchers will present new data advancing the science around the role of gene alterations and transcriptions in thyroid cancer diagnosis at the American Association of Clinical Endocrinologists (AACE) 25th Annual Scientific & Clinical Congress taking place May 25-29, 2016, in Orlando, Fla.

Physicians increasingly use Veracyte's Afirma® Gene Expression Classifier (GEC) to identify those patients whose thyroid nodules are benign (from among those with indeterminate pathology results), so that these patients can potentially avoid an unnecessary surgery. The company also offers its Afirma Malignancy Classifiers for medullary thyroid cancer and BRAF, helping to inform the extent of surgery needed for those patients who are going to surgery.

"The Afirma GEC's performance and utility have now been demonstrated in more than 20 published studies, which underscores the high level of clinical evidence we demand for our genomic tests," said Bonnie Anderson, president and chief executive officer of Veracyte. "We are applying this same scientific rigor to the study of gene alterations and transcriptions, as we assess their ability to help improve clinical decision-making for patients being evaluated for potential thyroid cancer."

The following study will be shared as an oral presentation at the AACE meeting, which is taking place at the Rosen Shingle Creek:

Title:                

Systematic Review of the Positive Predictive Value of RAS Mutations in Cytologically Indeterminate Thyroid Nodules (Abstract #1168)

Presenter:        

Mark A. Lupo, M.D., Thyroid & Endocrine Center of Florida

Date/Time:       

Saturday, May 28, 9:15-10:00 a.m.*

Location:          

Panzacola H 3/4


The following studies will be presented as posters:


Title:                

Evaluation of Thyroid FNA Genomic Signatures (ENHANCE): A Unique Biorepository for Advancing Science (Abstract #1162)

Presenter:        

Richard T. Kloos, M.D., Veracyte, Inc.

Date/Time:       

Friday, May 27, 5:00-6:30 p.m.

Location:          

Exhibit Hall



Title:                

Detection of Malignancy in Thyroid Carcinoma Samples Through Targeted DNA Sequencing (Abstract #1192)

Presenter:        

P. Sean Walsh, M.P.H., Veracyte, Inc.

Date/Time:       

Friday, May 27, 5:00-6:30 p.m.

Location:          

Exhibit Hall



* All Eastern Time

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 April 2015, the company launched the Percepta® Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. 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; our ability to successfully achieve adoption of and reimbursement for our Percepta Bronchial Genomic Classifier; 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 expand into international markets and achieve adoption of our tests in such markets; 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 March 31, 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.

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SOURCE Veracyte

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