- Interim CATALYST Study Findings Presented at PFF Summit -
In the interim report from the CATALYST clinical utility study, researchers found that two central MDTs - each comprised of a pulmonologist, radiologist and pathologist - diagnosed patients with suspected IPF similarly (92 percent agreement) when they were randomly assigned to review either the patients' surgical pathology or Envisia classifier results, along with clinical information and high-resolution computed tomography (HRCT). The study also showed that the Envisia classifier enabled the MDTs to agree on a diagnosis (94 percent agreement) based on Envisia classifier results, even when surgical pathology results were inconclusive. The findings are from a retrospective analysis involving 71 patients who were evaluated for potential IPF using HRCT, surgical pathology and genomic testing with the Envisia classifier.
"These findings signal a real potential for a shift in the current
diagnostic evaluation of patients undergoing evaluation for ILD," said
About Interstitial Lung Disease and Idiopathic Pulmonary Fibrosis
Each year in
About the Envisia Genomic Classifier
The Envisia Genomic Classifier is designed to improve physicians' ability to differentiate IPF from other ILDs without the need for surgery. The 190-gene classifier uses machine learning coupled with powerful, deep RNA sequencing to detect the presence or absence of usual interstitial pneumonia (UIP), a classic diagnostic pattern whose presence is essential for the diagnosis of IPF, using patient samples obtained through less-invasive transbronchial biopsy.
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 preliminary findings signal a real potential for a shift in the current diagnostic evaluation of patients undergoing evaluation for ILD, our belief that use of our test may remove many of the previous barriers to achieving a timely and accurate diagnosis, and the applicability of clinical results to actual outcomes. 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: the final results of the CATALYST clinical utility study; demand for 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; the size of the market opportunity for our products; 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; the timing and publication of clinical study results; 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.
News Provided by Acquire Media