Press Release

Veracyte Announces Data to be Presented at PFF Summit 2015 Highlighting IPF Diagnostic Challenges and Potential of New Genomic-Based Testing Approaches

November 4, 2015

SOUTH SAN FRANCISCO, Calif., Nov. 4, 2015 /PRNewswire/ -- Veracyte, Inc. (NASDAQ: VCYT) announced that company and external researchers will present four abstracts at the PFF Summit 2015: From Bench to Bedside that reveal current diagnostic challenges associated with interstitial lung disease (ILD), as well as the potential for improvement using new genomic-based testing approaches. The biennial international Summit is being held November 12-14 at the JW Marriott Hotel in Washington, DC.

Each year in the United States and Europe, up to 200,000 patients are suspected of having an ILD, including idiopathic pulmonary fibrosis (IPF), which is among the most common and most deadly, and is notoriously difficult to diagnose.

"The recent availability of therapies that slow progression of IPF makes improved, timely diagnosis of this disease even more imperative," said Bonnie Anderson, president and chief executive officer of Veracyte. "We are proud that the new research findings that we and others are sharing at this year's Summit help to elucidate the specific challenges associated with ILD and IPF diagnosis, as well as promising, potential solutions."

All four abstracts are part of a poster session taking place Thursday, November 12 from 5:00-8:00 p.m. EST in the Penn Avenue Terrace of the JW Marriott Hotel. During this session, researchers will share updated findings from a study evaluating the ability of a Veracyte molecular classifier to help distinguish IPF from other ILDs among patient samples obtained through bronchoscopy. This ability may potentially enable improved IPF diagnosis without the need for invasive surgery.  

Abstract Title: 

Diagnosis of idiopathic pulmonary fibrosis: Classifying the usual interstitial pneumonia pattern in transbronchial biopsies using machine learning

Presenter:    

Jing Huang, Ph.D., Veracyte

Three additional presentations will quantify the significant challenges that physicians and patients face in confirming an ILD diagnosis. These presentations include results from a national physician survey exploring the potential clinical utility of Veracyte's in-development molecular classifier to reduce the need for invasive diagnostic procedures, as well as assessing the degree to which non-specialist pulmonologists differ from ILD specialists in their use of invasive diagnostic procedures. Additionally, data from a national survey exploring the diagnostic experiences of 600 ILD and IPF patients will be presented. The latter survey was commissioned by the Pulmonary Fibrosis Foundation (PFF) with sponsorship from Veracyte. 

Abstract Title: 

The clinical utility of a molecular diagnostic in differentiating idiopathic pulmonary fibrosis from other interstitial lung diseases

Presenter:    

Xiaoping Wu, M.D., Weill Cornell Medical College



Abstract Title: 

Current diagnostic approaches in ILD: ILD versus non-specialty clinics

Presenter:    

Elizabeth Belloli, M.D., University of Michigan



Abstract Title: 

Interstitial lung disease patient diagnostic journey (INTENSITY) survey

Presenters:   

David J. Lederer, M.D., Pulmonary Fibrosis Foundation

All abstracts and results are embargoed until 5:00 p.m. EST, Thursday, November 12.

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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