Multiple Studies Showcasing Clinical Utility of Veracyte's Afirma® Gene Expression Classifier to Be Presented at ENDO 2016
SOUTH SAN FRANCISCO, Calif., March 29, 2016 /PRNewswire/ -- Veracyte, Inc. (NASDAQ: VCYT) today announced that company and external researchers will deliver poster presentations demonstrating the clinical utility of the Afirma Gene Expression Classifier (GEC) in thyroid cancer diagnosis, as well as advancing the genomic science around thyroid malignancy, at ENDO 2016, the annual conference of The Endocrine Society, being held April 1-4 in Boston.
"We continue to build the evidence demonstrating the real-world positive impact of the Afirma GEC on patient care. This further reinforces the test's role as a new standard of care in thyroid cancer diagnosis," said Bonnie Anderson, president and chief executive officer of Veracyte. "At the same time, our scientists continue to advance genomic-level understanding of thyroid cancer, in our ongoing effort to provide physicians with clinically useful information that can improve patient care."
The following abstracts will be presented during the general poster session on Saturday, April 2, 1:15-3:15 p.m. ET, in Hall AB1 (BCEC) at the Boston Convention and Exhibition Center:
Title: |
Systematic Review of Clinical Utility and Longer Term Follow Up of Afirma GEC Testing (poster #284) |
Presenter: |
Richard T. Kloos, M.D., Veracyte |
Title: |
Clinical Performance and Utility of Afirma GEC in a Community Hospital Practice (poster #282) |
Presenter: |
Michael Donovan Traynor, Jr., B.A., University of North Dakota School of Medicine and Health Sciences |
Title: |
Large-Scale Chromosomal Derangements in Hürthle Lesions Revealed by Multiple Genome-Wide High Density Platforms (poster #285) |
Presenter: |
Giulia C. Kennedy, Ph.D. |
Veracyte will also feature presentations from leading clinical experts at its booth (#309) during the ENDO 2016 conference, including an overview of the Afirma GEC in clinical practice, presented by Erik K. Alexander, M.D., chief, thyroid section, at Brigham and Women's Hospital.
About Afirma
Veracyte's Afirma Thyroid FNA Analysis is a comprehensive solution for improved thyroid nodule assessment. It centers on the Afirma Gene Expression Classifier, a 142-gene molecular test that identifies benign thyroid nodules among those deemed indeterminate by cytopathology, enabling these patients to potentially avoid an unnecessary surgery. An additional 25 genes are used to differentiate uncommon neoplasm subtypes. 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. Since the launch of the Afirma GEC in 2011, it has helped spare more than an estimated 20,000 patients from unnecessary thyroid surgery.
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 nearly 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. Veracyte is developing a second product in pulmonology, targeting 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 Annual Report on Form 10-K for the year ended December 31, 2015. 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, the Veracyte logo, and the Afirma logo are trademarks of Veracyte, Inc.
SOURCE Veracyte
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