VCYT Veracyte Inc

Veracyte Announces New Data Demonstrating “Real-World” Performance of Afirma GSC To Be Presented at ENDO 2018

Veracyte, Inc. (Nasdaq: VCYT) today announced that new data will be presented at ENDO 2018, the annual meeting of the Endocrine Society, underscoring the ability of the Afirma Genomic Sequencing Classifier (GSC) and the soon-to-be-launched Afirma Xpression Atlas platform to provide clinically useful information that can help guide physician and patient decision-making in thyroid cancer diagnosis. The meeting will be held March 17-20 in Chicago.

“These new data will reinforce Afirma’s ability to provide physicians with a single-source solution for improved thyroid cancer diagnosis,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “Specifically, real-world data will demonstrate the ability of the Afirma GSC to help even more patients avoid unnecessary surgery, as compared to our original, market-leading Afirma classifier. We also look forward to unveiling our soon-to-be-launched Afirma Xpression Atlas platform, which will give physicians unprecedented levels of genomic information that may potentially help guide surgery and treatment decisions for patients with suspected thyroid cancer.”

The following abstracts will be presented at ENDO 2018:
 
Title:   Afirma Genomic Sequencing Classifier Experience among the First 5478* Consecutive Samples from Cytologically Indeterminate Thyroid Nodules (Poster #SAT-659)
Presenter: Michael H. Shanik, M.D., Endocrine Associates of Long Island
Date/Time: Saturday, March 17, 1:00-3:00 p.m. Central Time
Location: ENDOExpo, Hall F
 
* This number has been updated from 1614, which was in the originally submitted abstract.
 
Title: The Mutational Landscape of 774 Variants and 132 Fusions in 513 Genes Measured in Thyroid FNAs from a Multicenter Blinded Cohort (Oral Abstract #OR17-4)
Presenter: Joshua E. Babiarz, Ph.D., Veracyte
Date/Time: Sunday, March 18, 12:00-12:15 p.m. Central Time
Location: Room W181
 
Veracyte also will host the following Product Theater event:
 
Title: “Evolving the Standard of Care: A Review of Afirma GSC Experience Data and Introducing the New Afirma Xpression Atlas”
Presenters: Giulia C. Kennedy, Ph.D. and Richard T. Kloos, M.D., Veracyte
Christian Nasr, M.D., Cleveland Clinic
Date/Time: Saturday, March 17, 1:00-2:00 p.m. Central Time
Location: Expo Theater 2030
 

About Afirma

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 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 included in most leading clinical guidelines and is covered as medically necessary by Medicare and all of the major U.S. health plans. The company plans to introduce the Afirma Xpression Atlas platform soon, which will use RNA sequencing to extract extensive genomic data – including gene expression, variants, fusions and loss of heterozygosity – from thyroid cytology samples.

About Veracyte

Veracyte, Inc. (Nasdaq: VCYT) is a leading genomic diagnostics company that is providing trustworthy and actionable answers that fundamentally improve patient care when current diagnostic tests are uncertain. The company's products uniquely combine genomic technology, clinical science and machine learning to provide answers that give physicians and patients a clear path forward without risky, costly surgery that is 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 regarding our Afirma Xpression Atlas platform, which we plan to introduce soon; and Afirma’s ability to significantly improve patient care and reduce healthcare costs. 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: 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 annual report on Form 10-K for the year ended December 31, 2017, and our other filings with the SEC, including our quarterly reports on Form 10-Q and current reports on Form 8-K. 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.

EN
14/03/2018

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