Press Release

Data from Multiple Studies Evaluating Veracyte's Genomic Classifiers for Lung Cancer and Idiopathic Pulmonary Fibrosis to Be Presented at ATS 2016

May 3, 2016

SOUTH SAN FRANCISCO, Calif., May 3, 2016 /PRNewswire/ -- Veracyte, Inc. (NASDAQ: VCYT) today announced that data from multiple studies supporting the company's genomic tests to resolve ambiguity in pulmonary disease diagnosis will be presented at the American Thoracic Society (ATS) 2016 International Conference taking place May 13-18 in San Francisco. Eight studies will be showcased at the event, including two as podium presentations.

Four presentations will provide data demonstrating the clinical utility, cost-effectiveness and analytical verification of Veracyte's Percepta® Bronchial Genomic Classifier, which is used to improve nonsurgical diagnosis of lung cancer. An additional four presentations will focus on the company's in-development classifier to help distinguish idiopathic pulmonary fibrosis (IPF) from other interstitial lung diseases (ILD). Findings will highlight the diagnostic challenges associated with IPF, as well as the potential of Veracyte's classifier to address these challenges and positively impact clinical decision making.

"The data being presented at this year's ATS conference further expand the substantial library of evidence demonstrating the ability of our Percepta classifier to help reduce unnecessary invasive procedures in lung cancer diagnosis," said Bonnie Anderson, president and chief executive officer of Veracyte. "Additionally, we are excited to showcase multiple posters confirming the potential of our ILD classifier to help clinicians deliver more accurate and timely IPF diagnosis, without the need for surgery."

The following studies will be shared as podium presentations at the meeting:

Title:            

Impact of a bronchial genomic classifier on clinical decision making in patients undergoing diagnostic evaluation for lung cancer (mini symposium C99)

Presenter:     

J. Scott Ferguson, M.D., University of Wisconsin, Madison

Date/Time:     

Tuesday, May 17, 2:15-4:15 p.m.*

Location:         

Moscone Center Room 306/308



Title:                

Cost-effectiveness of the Percepta Bronchial Genomic Classifier for the diagnostic evaluation of lung cancer: An analytical framework based on the AEGIS studies (mini symposium C99)

Presenter:       

David Feller-Kopman, M.D., Johns Hopkins School of Medicine

Date/Time:       

Tuesday, May 17, 2:15-4:15 p.m.

Location:          

Moscone Center Room 306/308

The following will be poster presentations:

Title:             

Analytical performance of a bronchial genomic classifier (#A1295)

Presenter:      

Duncan Whitney, Ph.D., Veracyte, Inc.

Date/Time:      

Sunday, May 15, 9:00-11:00 a.m.

Location:          

Moscone Center Room 304



Title:                

Bridging the gap between HRCT and final IPF diagnosis: Classifying the usual interstitial pneumonia pattern in transbronchial biopsies using machine learning on high dimensional genomic data (#A2381)

Presenter:      

Giulia C. Kennedy, Ph.D., Veracyte, Inc.

Date/Time:      

Sunday, May 15, 11:00 a.m.-12:45 p.m.

Location:          

Moscone Center Area D, Hall D



Title:                

Modeling the utility of a bronchial genomic classifier on procedure utilization in patients with suspected lung cancer (#A1287)

Presenter:        

Anil Vachani,M.D., University of Pennsylvania School of Medicine

Date/Time:      

Sunday, May 15, 9:00-11:00 a.m.

Location:          

Moscone Center Room 304



Title:               

The clinical utility of a genomic diagnostic test in differentiating usual interstitial pneumonia from other interstitial lung disease pathologies (#A6227)

Presenter:        

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

Date/Time:       

Tuesday, May 17, 2:15-4:15 p.m.

Location:          

Moscone Center Room 304



Title:                

A multicenter, prospective, blinded comparison of local histopathology and expert pathology panel diagnosis in ILD (#A5098)

Presenter:    

Urooj Imtiaz, M.D., Veracyte, Inc.

Date/Time:    

Tuesday, May 17, 2:15-4:15 p.m.

Location:        

Moscone Center Room 304



Title:               

Interstitial Lung Disease Patient Diagnostic Journey (INTENSITY) Survey (#A7894)

Presenter:        

Gregory P. Cosgrove, M.D., Pulmonary Fibrosis Foundation

Date/Time:       

Wednesday, May 18, 9:00-11:00 a.m.

Location:          

Moscone Center Room 304

* All Pacific Time

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 nearly 180 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 2016 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 Annual Report on Form 10-K for the year ended December 31, 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 of Veracyte, Inc.

 

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SOURCE Veracyte

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