SOUTH SAN FRANCISCO, Calif., May 7, 2014 /PRNewswire/ -- Veracyte, Inc. (Nasdaq: VCYT) announced that early data demonstrating the company's ability to develop a molecular classifier differentiating interstitial lung diseases (ILDs), including idiopathic pulmonary fibrosis (IPF), will be presented at the American Thoracic Society (ATS) 2014 International Conference taking place May 16-21, 2014 in San Diego.
"We are excited to share our first proof-of-concept data for the development of a molecular classifier designed to improve ILD diagnoses," said Bonnie Anderson, president and chief executive officer of Veracyte. "These conditions are often very challenging to diagnose, and the ability to deliver an early differential diagnosis without risky, invasive surgery could lead to significant improvement in treatment decisions for patients with suspected ILDs. This need is increasingly critical as the pipeline for IPF therapies expands, making increased life expectancy and quality of life improvements a possibility for patients who are accurately diagnosed."
The following abstract will be shared as part of "The Gold Fingerprint: Molecular Characterization of Interstitial Lung Disease," a mini-symposium at the ATS Conference:
Diagnosis of Interstitial Lung Diseases Using Machine Learning on High-Dimensional Transcriptional Data and Pathological and Clinical Assessment (C14)
Giulia C. Kennedy, PhD
Tuesday, May 20, 8:15 10:45 a.m. PT
Room 1 A-B (Upper Level), San Diego Convention Center
Veracyte (Nasdaq: VCYT) is pioneering the field of molecular cytology, focusing on 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 first commercial solution, the Afirma® Thyroid FNA Analysis, utilizes the proprietary Gene Expression Classifier (GEC) to resolve ambiguity in thyroid nodule diagnosis. Each year, of the more than 525,000 thyroid nodule FNAs performed in the U.S., approximately 115,000 patients undergo diagnostic thyroid surgery, with 70% to 80% of nodules proving benign and thus the surgery unnecessary. Since the commercial launch of Afirma in January 2011, Veracyte has received over 80,000 FNA samples for evaluation using Afirma and has performed approximately 16,000 GECs to resolve indeterminate cytopathology results, as of December 31, 2013. Backed by multiple, peer-reviewed, published studies and included in leading medical guidelines, Afirma is covered by Medicare and major commercial payers, which collectively represent more than 120 million covered lives. Afirma is marketed and sold through a global co-promotion agreement with Genzyme Corporation, a subsidiary of Sanofi. Veracyte intends to expand its molecular cytology franchise to other clinical areas and is in late biomarker discovery for its first product in pulmonology. For more information, please visit www.veracyte.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the potential benefits and attributes of a molecular classifier for ILDs, and the need for such a classifier; and the company's intent to expand its molecular cytology business into other clinical areas. 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 any future products we may develop; 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; our ability to develop and commercialize new products and the timing of commercialization; the occurrence and outcome of clinical studies; the applicability of clinical results to actual outcomes; the timing and publication of study results; our inclusion in clinical practice guidelines; our ability to compete; our ability to expand into international 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, 2013. 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, the Veracyte logo, and the Afirma logo are trademarks of Veracyte, Inc. This press release also contains trademarks and trade names that are the property of their respective owners.
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