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Veracyte Announces Data Supporting Use of the Percepta™ Bronchial Genomic Classifier to Be Presented at CHEST 2015

SOUTH SAN FRANCISCO, Calif., Oct. 20, 2015 /PRNewswire/ — Veracyte, Inc. (VCYT), a molecular diagnostics company pioneering the field of molecular cytology, announced that data assessing the clinical utility and performance of the company’s genomic test to improve lung cancer diagnosis will be presented at the CHEST 2015 Annual Meeting, being held October 24-28 in Montreal, Canada.

Data from the first study suggest the ability of the Percepta Bronchial Genomic Classifier to reduce unnecessary, invasive and costly diagnostic procedures following inconclusive bronchoscopy results among patients being evaluated for potentially cancerous lung nodules or lesions. The second abstract reviews the AEGIS I and II studies, which validated the Percepta test’s ability to identify patients who are at low risk of malignancy following an inconclusive bronchoscopy.

“Diagnostic ambiguity in lung cancer and the invasive, risky and costly procedures that often result put tremendous strain on patients, medical professionals and the healthcare system. This challenge becomes even more pronounced as millions of Americans at high risk of lung cancer have recently become eligible for annual CT screening,” said Bonnie Anderson, president and chief executive officer of Veracyte. “We are extremely pleased to further build the evidence supporting the use of the Percepta test to help reduce unnecessary invasive procedures in lung cancer diagnosis.” 

The following two Percepta abstracts will be presented during the session, “Lung Cancer Diagnosis” (Session #202603), on Wednesday, October 28, beginning at 2:45 p.m. Eastern Time in the Montreal Convention Center, Room 512 C-G:

Abstract Title:

Clinical Utility of a Bronchial Genomic Classifier: An Analysis of Invasive Procedure

Utilization in the AEGIS Trials

Presenter:

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

Abstract Title:

Prospective Validation of a Bronchial Genomic Classifier for Lung Cancer in Patients

Undergoing Diagnostic Bronchoscopy: The AEGIS Trials

Presenter:

Avrum Spira, M.D., Boston University School of Medicine

About Veracyte

Veracyte (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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