SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Veracyte, Inc. (Nasdaq: VCYT) today announced the launch of the new Afirma Xpression Atlas, an RNA sequencing-based test that provides extensive genomic information to aid in surgery and treatment decisions for patients with potentially cancerous thyroid nodules. The new test is being introduced at the AACE 27th Annual Scientific & Clinical Congress where robust test performance data will be shared in a Product Theater event and poster presentation by Veracyte and external researchers. The AACE meeting is being held May 16-20 in Boston.
The Afirma Xpression Atlas detects 761 DNA variants and 130 RNA fusion pairs in over 500 genes that have been linked to thyroid cancer. In some cases, these gene alterations have demonstrated association with more aggressive thyroid cancers or with higher-stage disease.
“For patients who are already going to surgery for suspected thyroid cancer, the Afirma Xpression Atlas provides additional genomic information that physicians and patients may use in decisions about the surgical approach,” said Peter M. Sadow, M.D., Ph.D., of Massachusetts General Hospital and Harvard Medical School. “Additionally, as more is understood about gene alterations and their impact on thyroid cancer development, prognosis and tumor pathway dependence, this RNA sequencing information may help to further guide patient care.” Dr. Sadow will present performance data for the Xpression Atlas test during a poster session at the AACE meeting on Saturday, May 19.
The gene variants and fusion partners in the Afirma Xpression Atlas were derived from the thyroid literature and from The Cancer Genome Atlas (TCGA). The RNA-sequencing based panel is offered as an extension to Veracyte’s market-leading Afirma Genomic Sequencing Classifier (GSC), which is widely used to identify benign nodules among those deemed indeterminate by cytopathology so that patients can avoid unnecessary surgery.
“In tandem with our Afirma GSC, the Afirma Xpression Atlas provides physicians with the most comprehensive and evidence-based genomic information available to inform diagnosis, stratify thyroid cancer risk and, for those who are diagnosed with cancer, aid in therapeutic selection,” said Bonnie Anderson, Veracyte’s chairman and chief executive officer.
More information about Afirma data being presented at the AACE meeting can be found at Veracyte’s booth (#707) or at www.veracyte.com/AACE2018.
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.
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.
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