SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte, Inc. (NASDAQ: VCYT) announced that data confirming the analytical validity of the company’s Envisia™ Genomic Classifier have been published online in the journal BMC Pulmonary Medicine. The findings add to the growing body of evidence, including previously reported clinical validity and clinical utility data, supporting the use of the Envisia classifier to enable diagnosis of idiopathic pulmonary fibrosis (IPF), without the need for invasive, risky and costly surgical procedures.
“These new data underscore the scientific rigor behind the Envisia Genomic Classifier and should give physicians and their patients even more confidence in the test’s results,” said Giulia C. Kennedy, Ph.D., chief scientific officer of Veracyte. “By providing information that until now could only be obtained through diagnostic surgery, the Envisia classifier should help patients with suspected IPF get clearer answers faster so that they can receive the treatment they need – and avoid potentially harmful invasive procedures.”
In the new study, Veracyte researchers found that the Envisia classifier’s performance demonstrated highly accurate, reproducible, and reliable results across a range of laboratory conditions and variables. This included the stability of patient samples during collection, shipment and storage, as well as consistent test performance despite variations in RNA quantity and potential blood and DNA contamination, which may occur in routine clinical practice. The study also showed that the test’s results were reproducible across operators, processing runs, reagent lots and laboratories.
About the Envisia Genomic Classifier
The Envisia Genomic Classifier provides answers that improve physicians' ability to differentiate idiopathic pulmonary fibrosis (IPF) from other interstitial lung diseases (ILDs) without the need for invasive, risky and costly surgery. The 190-gene classifier employs RNA sequencing to provide the core information needed by physicians to make an ILD diagnosis, using samples obtained through less-invasive bronchoscopy. The test is designed to provide information that was previously only available through surgical lung biopsy and by expert pathology review. Veracyte believes that the use of the Envisia classifier can provide a new standard of care for IPF patients, reducing the number of surgeries in IPF diagnosis, speeding the time to diagnosis and saving healthcare costs.
About Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis
Each year in the United States and Europe, up to 200,000 patients are evaluated for suspected ILD, including IPF, which is among the most common, deadly and difficult to diagnose of these lung-scarring diseases. Physicians routinely use high-resolution computed tomography (HRCT) to help identify IPF, but this approach frequently provides inconclusive results, leading many patients to undergo invasive and potentially risky surgery for a more definitive diagnosis. Other patients are too frail to undergo surgery and may never receive an accurate diagnosis, which can result in suboptimal - and potentially harmful - treatment.
Veracyte (NASDAQ: VCYT) is a leading genomic diagnostics company that is providing trustworthy and actionable answers that fundamentally improve patient care when current diagnostic tests are uncertain. The company’s products uniquely combine genomic technology, clinical science and machine learning to provide answers that give physicians and patients a clear path forward without risky, costly surgery that is 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 the use of the Envisia classifier to enable diagnosis of idiopathic pulmonary fibrosis, without the need for invasive, risky and costly surgical procedure; Envisia’s ability to further give physicians confidence in using our test in lieu of surgery; and Envisia’s ability to significantly improve patient care and reduce healthcare costs. 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: benefits of our tests, the applicability of clinical results to actual outcomes; laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; 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 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 September 30, 2017. 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.
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