Veracyte Announces Multiple Studies to Be Presented at ATA Annual Meeting Demonstrating “Real World” Performance of Afirma GSC and Xpression Atlas in Thyroid Cancer Diagnosis

September 26, 2018

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep 26, 2018--Veracyte, Inc. (Nasdaq: VCYT) today announced that findings from six studies will be presented at the 88 th Annual Meeting of the American Thyroid Association (ATA), demonstrating the “real world” performance of the Afirma Genomic Sequencing Classifier (GSC) and Afirma Xpression Atlas in thyroid cancer diagnosis. The findings will be shared in two oral and four poster presentations at the ATA annual meeting, which will be held October 3-7 in Washington, D.C.

“With its RNA sequencing and machine learning foundation, Afirma answers challenging clinical questions to help guide patient care in thyroid cancer diagnosis,” said Bonnie Anderson, chairman and chief executive officer of Veracyte. “These new data show that the Afirma GSC can help even more patients avoid unnecessary diagnostic surgery when their thyroid nodules are indeterminate, compared to the original Afirma test. Data to be presented at the ATA meeting also demonstrate the Xpression Atlas’s accuracy in detecting rich genomic content on thyroid fine needle aspiration samples. This information may help guide surgery and treatment decisions for patients with suspected or confirmed cancer – and may also provide a vital bridge to emerging precision-medicine therapies.”

About Afirma

Veracyte’s Afirma solution provides a comprehensive offering in thyroid cancer diagnosis for physicians evaluating patients with thyroid nodules. The Afirma Genomic Sequencing Classifier combines RNA sequencing data with machine learning to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to avoid unnecessary surgery and preserve the thyroid. Since the commercial introduction of Afirma in 2011, Veracyte has performed over 100,000 genomic tests, and estimates it has saved more than 40,000 patients from unnecessary thyroid surgery and removed an estimated $800 million in surgery costs from the healthcare system. The Afirma classifier is proven in over 20 published clinical studies, is included in most leading clinical guidelines and is covered as medically necessary by Medicare and all major U.S. health plans. The company’s Afirma Xpression Atlas platform, introduced in May 2018, provides extensive genomic data that may inform surgery strategy and treatment options for patients with thyroid nodules that are suspicious for cancer or cancerous. The RNA sequencing-based platform measures 761 DNA variants and 130 RNA fusions in over 500 genes shown to be associated with thyroid cancer on thyroid nodule fine needle aspiration samples.

About Veracyte

Veracyte (Nasdaq: VCYT) is a leading genomic diagnostics company that improves patient care by providing trustworthy and actionable answers to challenging clinical questions. The company’s products uniquely combine advanced genomic technology, clinical science and machine learning to provide answers that give physicians and patients a clear path forward, informing both diagnosis and treatment decisions without the need for costly, risky surgeries that are often unnecessary. Since its founding in 2008, Veracyte has commercialized three genomic tests, which are transforming the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis and collectively target a $2 billion market opportunity. Veracyte is based in South San Francisco, California. For more information, please visit www.veracyte.com and follow the company on Twitter (@veracyte).

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, our belief that our genomic tests will transform the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis; statements about the ability of Afirma GSC to improve upon the original Afirma test; and statements about the accuracy of the Xpression Atlas. 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 ability to achieve Medicare coverage for our tests, the market opportunity for the Envisia classifier, the benefits of our tests, the applicability of clinical results to actual outcomes; the laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our ability to sell our Afirma tests and successfully transition to our next-generation Afirma GSC; our ability to successfully achieve and maintain adoption of and reimbursement for our products; the amount by which use of our products are able to reduce invasive procedures and misdiagnosis, and reduce healthcare costs; the occurrence and outcomes of clinical studies; and other risks set forth in our filings with the Securities and Exchange Commission, including the risks set forth in our quarterly report on Form 10-Q for the quarter ended June 30, 2018. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.

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

View source version on businesswire.com:https://www.businesswire.com/news/home/20180926005305/en/

CONTACT: Veracyte Media & Investor Contact:

Angie McCabe, 650-243-6371

Vice President, Investor Relations & Corporate Communications




SOURCE: Veracyte, Inc.

Copyright Business Wire 2018.

PUB: 09/26/2018 08:15 AM/DISC: 09/26/2018 08:15 AM


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