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- New data support role of Percepta Genomic Atlas in genomic profiling for lung cancer patients –
- Study suggests Envisia classifier can be successfully enabled on nCounter Analysis System -
Veracyte, Inc. (Nasdaq: VCYT) announced today that new data demonstrating the clinical capability of the Percepta® Genomic Atlas for informing lung cancer treatment decisions, as well as the technical feasibility of enabling the company’s Envisia® Genomic Classifier on the nCounter Analysis System, will be presented at the American Thoracic Society (ATS) 2021 International Conference. Multiple posters reinforcing the Envisia classifier’s diagnostic performance will also be presented at the meeting, which will be held virtually May 14-19, 2021.
"The data being presented at ATS suggest that the Percepta Genomic Atlas can provide information that will accelerate appropriate treatment for patients following a lung cancer diagnosis and, importantly, that the test provides this information regardless of disease stage," said Bonnie Anderson, Veracyte’s chairman and chief executive officer. "We’re also very excited about the new data demonstrating that we can successfully enable the Envisia classifier on the nCounter system, maintaining the test’s clinical performance while enabling access for patients globally through local labs."
The Percepta Genomic Atlas provides comprehensive genomic profiling information on cancerous lung nodules, utilizing small samples from the same biopsy used for diagnosis. Data to be shared at ATS show that the in-development test accurately detects known gene variants in lung cancer using bronchoscopy samples, potentially enabling earlier and more appropriate treatment with currently available and in-development targeted therapies.
The Envisia Genomic Classifier is a genomic test that detects a genomic pattern of usual interstitial pneumonia (UIP) to improve interstitial lung disease (ILD) diagnostic and prognostic confidence. The classifier is performed in Veracyte’s U.S.-based CLIA laboratory. In December 2019, Veracyte acquired the exclusive global diagnostics rights to the nCounter Analysis System, a CE-marked and FDA-cleared decentralized molecular testing platform. The company plans to make the Envisia classifier available on the nCounter platform in international markets by the end of this year.
Following are details of the Percepta Genomic Atlas and Envisia classifier posters accepted for presentation at ATS. These posters will be available to meeting registrants on demand beginning May 14 through July 2, 2021:
Identification of Driver Mutations in Transbronchial Needle Aspirates of Suspicious Lung Nodules Concurrent with Diagnostic Bronchoscopy, Abstract #A4825
Joshua Babiarz, Ph.D., Veracyte
Envisia Genomic Classifier Demonstrates Consistent Performance Across Gender, Age Group, and Smoking Status. Abstract #A1839
Luca Richeldi, M.D., Ph.D., Università Cattolica del Sacro Cuore, Rome, Italy
Envisia Genomic Classifier Helps Improve Multidisciplinary Diagnoses of Complex Interstitial Lung Diseases, Abstract #A1877
Lisa H. Lancaster, M.D., Vanderbilt University Medical Center
Cryobiopsy and Genomic Classifier (Envisia) in the Diagnosis of Usual Interstitial Pneumonia, Abstract #A4236
R. Ronaghi, M.D., University of California, Los Angeles
Role of the Envisia Genomic Classifier in Establishing a Diagnosis of Idiopathic Pulmonary Fibrosis, Abstract #1837
M. Abdalla, M.D., Pulmonary and Critical Care Medicine, Medical College of Wisconsin
Bridging the Envisia Genomic Classifier to the nCounter Platform: A Proof-of-Concept Study, Abstract #A4352
Huimin Jiang, Ph.D., Veracyte
Veracyte (Nasdaq: VCYT) is a global genomic diagnostics company that improves patient care by providing answers to clinical questions, informing diagnosis and treatment decisions throughout the patient journey in cancer and other diseases. The company’s growing menu of genomic tests leverage advances in genomic science and technology, enabling patients to avoid risky, costly diagnostic procedures and quicken time to appropriate treatment. The company’s tests in lung cancer, prostate cancer, breast cancer, thyroid cancer, bladder cancer and idiopathic pulmonary fibrosis are available to patients and its lymphoma subtyping and renal cancer tests are in development. With Veracyte’s exclusive global license to a best-in-class diagnostics instrument platform, the company is positioned to deliver its tests to patients worldwide. 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, including, but not limited to, our statements related to our plans, objectives, expectations (financial and otherwise) or intentions with respect to the Percepta Genomic Atlas and our Envisia tests. Forward-looking statements can be identified by words such as: "anticipate," "intend," "plan," "expect," "believe," "should," "suggest," "may," "will" and similar references to future periods. Actual results may differ materially from those projected or suggested in any forward-looking statements. Examples of forward-looking statements include, among others, statements regarding Veracyte’s belief that its Percepta Genomic Atlas and its Envisia tests provide clinical value that helps physicians diagnose and treat lung cancer and IPF, and the ability of Veracyte to expand the menu of advanced genomic tests on the nCounter Analysis System. These statements involve risks and uncertainties, which could cause actual results to differ materially from our predictions, and include, but are not limited to: Veracyte’s ability to achieve and maintain Medicare coverage for its tests; the benefits of Veracyte’s tests and the applicability of clinical results to actual outcomes. Additional factors that may impact these forward-looking statements can be found under the caption "Risk Factors" in our Annual Report on Form 10-K filed with the SEC on February 22, 2021 and our subsequent quarterly reports on Form 10-Q. A copy of these documents can be found at the Investors section of our website at www.veracyte.com. The risks and uncertainties may be amplified by the COVID-19 pandemic, which has caused significant economic uncertainty. The extent to which the COVID-19 pandemic impacts Veracyte’s businesses, operations, and financial results, including the duration and magnitude of such effects, will depend on numerous factors, which are unpredictable, including, but not limited to, the duration and spread of the outbreak, its severity, the actions to contain the virus or treat its impact, and how quickly and to what extent normal economic and operating conditions can resume. These forward-looking statements speak only as of the date hereof and, except as required by law, 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.
Veracyte, Afirma, Percepta, Envisia, Prosigna, "Know by Design" and the Veracyte, Afirma, Percepta, Envisia and Prosigna logos are registered trademarks of Veracyte in the U.S. and selected countries.
nCounter is the registered trademark of NanoString Technologies, Inc. in the United States and other countries and used by Veracyte under license.
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