Two New Studies Demonstrate the Long-Term Clinical Utility of Veracyte's Afirma® Gene Expression Classifier in Safely Reducing Unnecessary Thyroid Surgeries

SOUTH SAN FRANCISCO, Calif., Oct. 21, 2015 /PRNewswire/ -- Veracyte, Inc. (NASDAQ: VCYT), a molecular diagnostics company pioneering the field of molecular cytology, announced findings from two new studies demonstrating the long-term clinical utility of the Afirma^® Gene Expression Classifier (GEC). The genomic test is used to help avoid unnecessary surgeries among patients whose thyroid nodule fine needle aspiration (FNA) biopsy results are indeterminate (not clearly benign or cancerous). The new findings were presented today at the 15^th International Thyroid Congress (ITC) and 85^th Annual Meeting of the American Thyroid Association (ATA), being held October 18-23, 2015 in Lake Buena Vista, Fla.

In the first study, researchers used the HealthCore Integrated Research Database (HIRD^®) to compare outcomes during follow-up of 201 patients with benign Afirma GEC results to a matched control group of 603 patients with benign cytopathology results. They found that, over an average follow-up period of 20 months, Afirma GEC-benign patients were no more likely to undergo thyroid surgery than the control group (11 percent vs. 10 percent). The rate of ultrasound follow-up examinations was also similar among the Afirma GEC-benign patients (60 percent), compared to the cytopathology-benign group (62 percent).

"Traditionally, many patients with indeterminate thyroid nodules could be directed to unnecessary thyroid surgery, only for many of them to learn afterwards that their nodules were benign," said Joseph Singer, M.D., chief medical officer of HealthCore, a wholly-owned subsidiary of Anthem, Inc., and lead author of the Veracyte-sponsored study. "Our findings suggest that use of the Afirma GEC could change the trajectory of care for many of these patients, enabling them to stay out of the operating room."

Dr. Singer presented the data today in a poster titled, "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).

The second clinical utility study assessed surgery rates for Afirma GEC-benign patients who were tested at 16 community-based practices and followed for three years. The researchers found that 81 out of 98 patients (82.7 percent) with a benign Afirma GEC result avoided surgery during 36 months of follow up, with the majority (88 percent) of any surgeries occurring within the first two years. In comparison, the historical rate of surgery avoidance is just 26 percent for patients with cytopathology-indeterminate nodules.

"Our study showed that a 'benign' Afirma GEC result in a community setting is associated with a significantly lower rate of surgery compared to historical practice, over an extended period of time," said lead author Jennifer A. Sipos, M.D., associate professor of medicine at The Ohio State University. "Our findings suggest that a benign Afirma GEC result is durable and that physicians have high levels of confidence in the genomic test's ability to identify patients whose nodules are benign and may be observed in lieu of going to surgery."

Dr. Sipos presented the study results in a poster titled, "Long-Term Non-Operative Rate of Thyroid Nodules with Benign Results on the Afirma Gene Expression Classifier" (poster #838).

"The new data presented today highlight the profound, real-world impact that the Afirma GEC is having on clinical decision-making in thyroid cancer diagnosis," said Bonnie Anderson, president and chief executive officer of Veracyte. "We believe these findings further add to the growing library of clinical evidence supporting the continued adoption and reimbursement of the Afirma GEC." To date, the Afirma GEC is covered for approximately 150 million Americans through their insurers.

Veracyte also presented a poster today titled, "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). The results show a doubling of the identification of BRAF-positive nodules in patients with a "suspicious" Afirma GEC result, compared to the general indeterminate group. The findings suggest the potential utility of such mutation testing in patients with a Afirma GEC-suspicious result, which may help physicians determine the extent of thyroid surgery needed. 

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. 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 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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