Press Release

Veracyte Announces Data from Multiple Afirma® Gene Expression Classifier Studies to Be Presented at the 15th International Thyroid Congress

October 16, 2015

SOUTH SAN FRANCISCO, Calif., Oct. 16, 2015 /PRNewswire/ -- Veracyte, Inc. (NASDAQ: VCYT) today announced that company scientists and external researchers will present multiple oral and poster presentations supporting the use of the Afirma Gene Expression Classifier (GEC), as well as advancing the science around the role of gene alterations in thyroid cancer diagnosis, at the 15th International Thyroid Congress (ITC) and 85th Annual Meeting of the American Thyroid Association (ATA), being held October 18-23 in Lake Buena Vista, Fla.

Physicians increasingly use Veracyte's Afirma GEC, which became available in the United States in January 2011, to help patients avoid unnecessary surgery when their thyroid nodules are deemed indeterminate (not clearly benign or malignant) following traditional cytopathology evaluation. In 2014, the company launched its Afirma Malignancy Classifiers for medullary thyroid cancer and BRAF, helping to guide surgical decision-making for patients with thyroid nodules who are already going to surgery.

"We continue to expand the deep library of evidence demonstrating the clinical utility of our Afirma solution in improving physician decision-making for their thyroid nodule patients," said Bonnie Anderson, Veracyte's president and chief executive officer. "We are now also bringing the same scientific rigor to the study of gene alterations, which are increasingly common in the scientific literature, to help physicians determine how these alterations can best provide clinically useful information in thyroid cancer diagnosis."

The following abstract will be shared as a short oral presentation, as well as a poster, at the ITC meeting, taking place at the Walt Disney World Swan and Dolphin Resort:


Title:

Oncogenic Mutations in Thyroid Carcinoma and Their Power to Detect Malignancy in Diverse Neoplasms (Abstract #499)

Presenter:

R. Kloos, M.D., Veracyte

Date/Time:

Wednesday, October 21, 4:00-4:30 p.m. (oral presentation)


Wednesday, October 21, and Thursday, October 22, 9:00 a.m. (poster presentation)

Location:

Northern Hemisphere Rooms E3 and E4 (oral presentation) and Atlantic Hall (poster presentation)



The following abstracts will be presented during the General Poster Session in Atlantic Hall at the Walt Disney World Swan and Dolphin Resort:


Title:

Surgery Rates and Ultrasound Follow-Up for Afirma GEC Benign Patients Are Equivalent to Matched Cytopathology Benign Patients in a National Managed Health Plan Database (Poster #30)

Presenter:

J. Singer, M.D., HealthCore

Date/Time:

Monday, October 19, and Tuesday, October 20, 9:00 a.m.



Title:

Long-Term Non-Operative Rate of Thyroid Nodules with Benign Results on the Afirma Gene Expression Classifier (Poster #838)

Presenter:

J.A. Sipos, M.D., The Ohio State University

Date/Time:

Wednesday, October 21, and Thursday, October 22, 9:00 a.m.



Title:

Long-Term Follow-Up of an Office-Based Gene Expression Classifier to Manage Thyroid Nodules Over Four and One Half Years (Poster #824)

Presenter:

B.E. Michael, M.D., Wellspan Health

Date/Time:

Wednesday, October 21, and Thursday, October 22, 9:00 a.m.



Title:

Afirma BRAF Testing Across Cytology Subtypes Among 9,188 Thyroid FNA Biopsies Demonstrates High Prevalence of BRAF V600E Mutations in Bethesda V and VI Nodules (Poster #301)

Presenter:

R. Kloos, M.D., Veracyte

Date/Time:

Monday, October 19, and Tuesday, October 20, 9:00 a.m.

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 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.

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 2015 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 June 30, 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 or registered trademarks of Veracyte, Inc.

 

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SOURCE Veracyte

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