Veracyte Announces New Data Reinforcing Clinical Value of Genomic Tests In Lung Disease Diagnoses to Be Presented at CHEST Annual Meeting 2018

September 27, 2018

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Sep 27, 2018--Veracyte, Inc. (NASDAQ: VCYT) announced that new data highlighting the ability of the Percepta Bronchial Genomic Classifier to reduce unnecessary invasive procedures in lung cancer diagnosis will be shared in an oral presentation at CHEST 2018, the annual meeting of the American College of Chest Physicians ®. In addition, new data demonstrating that the Envisia Genomic Classifier provides reliable results to help physicians more confidently diagnose interstitial lung disease (ILD), including idiopathic pulmonary fibrosis (IPF), will be highlighted in a second oral presentation at the meeting. CHEST 2018 will be held October 6-10 in San Antonio, Texas.

“These new study data supporting the Percepta and Envisia classifiers add to the growing body of evidence demonstrating that our genomic tests enable more confident diagnoses of lung cancer and ILDs, including IPF,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “We are committed to ensuring that physicians who treat these diseases feel confident that the Percepta and Envisia classifiers will give them reliable answers to help inform accurate and timely diagnoses, without the need for surgery.”

Lung cancer and ILD/IPF are often difficult to diagnose without invasive procedures. As a result, many patients endure risky, costly diagnostic surgery that may be unnecessary; delayed and potentially inappropriate treatment; and anxiety.

The following Percepta and Envisia study data will be presented at CHEST 2018:

About Percepta

The Percepta Bronchial Genomic Classifier uses advanced genomic and machine learning technology to improve lung cancer diagnosis for patients while reducing the need for invasive procedures. The classifier is run when bronchoscopy results are inconclusive, and helps physicians determine which patients are at low or very low risk for cancer and may therefore be monitored with CT scans instead of undergoing further, invasive diagnostic procedures. The Percepta classifier uses proprietary “field of injury”-based technology to detect molecular changes in the main lung airway of current or former smokers. Percepta detects these genomic changes to determine the likelihood that a nodule is cancerous without the need to sample the nodule directly. The classifier’s performance has been validated in multiple, rigorous clinical studies, including clinical validation data published in The New England Journal of Medicine.

About Envisia

The Envisia Genomic Classifier is the first commercially available test to improve the diagnosis of idiopathic pulmonary fibrosis (IPF). The Envisia test enables physicians to more confidently differentiate IPF from other interstitial lung diseases (ILD), helping to guide an optimal patient treatment plan that can improve outcomes and reduce risk. The classifier works by harnessing the power of RNA sequencing and machine learning to detect a genomic pattern of usual interstitial pneumonia (UIP), whose presence is required for IPF diagnosis. The Envisia test is proven to detect UIP with high correlation to the gold standard – histopathology results read by ILD experts – without the need for surgery.

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 regarding the ability of the Percepta Bronchial Genomic Classifier to reduce unnecessary invasive procedures in lung cancer diagnosis; and statements regarding the ability of the Envisia Genomic Classifier to improve IPF diagnosis. 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.

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CONTACT: Veracyte Media & Investor Contact:

Angie McCabe, 650-243-6371

Vice President, Investor Relations & Corporate Communications




SOURCE: Veracyte, Inc.

Copyright Business Wire 2018.

PUB: 09/27/2018 08:15 AM/DISC: 09/27/2018 08:15 AM


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