SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte, Inc. (Nasdaq: VCYT) today announced that it will commercially launch its Afirma Xpression Atlas and present performance data for the RNA sequencing-based platform at the AACE 27th Annual Scientific & Clinical Congress. The Afirma Xpression Atlas leverages robust genomic content to provide physicians with gene alteration information that may help guide surgery and treatment decisions in patients with potentially cancerous thyroid nodules. Additionally, data from multiple “real world” studies demonstrating the Afirma Genomic Sequencing Classifier’s (GSC) ability to significantly reduce unnecessary surgeries in thyroid cancer diagnosis will be presented at the American Association of Clinical Endocrinologist’s (AACE) annual meeting, which is being held May 16-20 in Boston.
“Our RNA sequencing capabilities enable us to assess thyroid nodules at a much more granular genomic level than previously possible,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer. “As a result, we believe the new Afirma Xpression Atlas, in combination with our Afirma Genomic Sequencing Classifier, will provide physicians with the most comprehensive, effective tool for diagnosing and managing patients who are being evaluated for potential thyroid cancer.”
The following abstract will demonstrate the ability of the RNA-based Afirma Xpression Atlas to identify – from fine-needle aspiration samples – 761 DNA variants and 130 RNA fusions partners in over 500 genes that are associated with thyroid cancer:
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Title: |
Detecting Expressed Variants and Fusions in RNA-Seq Data from Thyroid FNAs (Poster #1227) |
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Presenter: |
Peter M. Sadow, M.D., Massachusetts General Hospital and Harvard Medical School |
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Date/Time: |
Saturday, May 19, 10:00-11:00 a.m. Eastern Time |
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Location: |
Hynes Convention Center, Exhibit Hall |
| The following abstracts will demonstrate the next-generation Afirma GSC’s ability to identify significantly more benign thyroid nodules, as compared to the original Afirma test: | |
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Title: |
Afirma GSC: Early Endocrine Surgical Practice Performance |
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Presenter: |
Richard M. Harrell, M.D., Memorial Healthcare System (Poster #1200) |
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Date/Time: |
Saturday, May 19, 10:00-11:00 a.m. Eastern Time |
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Location: |
Hynes Convention Center, Exhibit Hall |
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Title: |
Early Experience of Gene Sequencing Classifier Compared to Gene Expression Classifier (Poster #1211) |
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Presenter: |
Mayumi Endo, M.D., The Ohio State University |
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Date/Time: |
Saturday, May 19, 10:00-11:00 a.m. Eastern Time |
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Location: |
Hynes Convention Center, Exhibit Hall |
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Title: |
High Afirma GSC Benign Call-Rate and Estimated Negative Predictive Value (Poster #1229) |
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Presenter: |
Sharif Ahmed, M.D., Lankenau Medical Center |
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Date/Time: |
Saturday, May 19, 10:00-11:00 a.m. Eastern Time |
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Location: |
Hynes Convention Center, Exhibit Hall |
| Veracyte also will host the following Product Theater event: | |
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Title: |
Evolving the Standard of Care—Reviewing Afirma GSC Experience and Introducing the New Xpression Atlas |
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Presenters: |
Giulia C. Kennedy, Ph.D., and Richard T. Kloos, M.D., Veracyte |
| Christian Nasr, M.D., Cleveland Clinic | |
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Date/Time: |
Friday, May 18, 1:15-2:00 p.m. Eastern Time |
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Location: |
Hynes Convention Center, Product Theater B |
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For more information, please visit AACE 2018 Booth #707 or www.veracyte.com/AACE2018. |
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About Afirma
Veracyte’s Afirma solution provides a comprehensive solution for physicians evaluating patients with potentially cancerous thyroid nodules. The Afirma Genomic Sequencing Classifier combines RNA sequencing data with machine learning to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to avoid unnecessary surgery and preserve the thyroid. Since the commercial introduction of Afirma in 2011, Veracyte has performed over 100,000 genomic tests, and estimates it has saved more than 40,000 patients from unnecessary thyroid surgery and removed an estimated $800 million in surgery costs from the healthcare system. The Afirma classifier is proven in over 20 published clinical studies, is included in most leading clinical guidelines and is covered as medically necessary by Medicare and all major U.S. health plans. The company’s Afirma Xpression Atlas platform, introduced in May 2018, provides extensive genomic data that may inform surgery strategy and treatment options for patients with thyroid nodules that are suspicious for cancer. The RNA sequencing-based platform measures 761 DNA variants and 130 RNA fusions in over 500 genes shown to be associated with thyroid cancer on thyroid nodule fine needle aspiration samples.
About Veracyte
Veracyte, Inc. (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 our genomic tests will transform the diagnosis of thyroid cancer, lung cancer and idiopathic pulmonary fibrosis; statements regarding our Afirma Xpression Atlas platform, which we plan to introduce soon; and Afirma’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: the benefits of our tests, the applicability of clinical results to actual outcomes; the laws and regulations applicable to our business, including potential regulation by the Food and Drug Administration or other regulatory bodies; our ability to sell our Afirma tests and successfully transition to our next-generation Afirma GSC; 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 our filings with the Securities and Exchange Commission, including the risks set forth in our quarterly report on Form 10-Q for the quarter ended March 31, 2018. 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.
Veracyte, Afirma, Percepta, Envisia, the Veracyte logo, and the Afirma logo are trademarks of Veracyte, Inc.
