Veracyte, Inc.
Apr 26, 2017

Veracyte Announces Multiple Studies Demonstrating Powerful Results from Afirma® Classifiers To Be Presented at the AACE 2017 Annual Meeting

Data from pivotal clinical validation study for Veracyte's next-generation Afirma Genomic Sequencing Classifier to be unveiled

SOUTH SAN FRANCISCO, Calif., April 26, 2017 /PRNewswire/ -- Veracyte, Inc. (NASDAQ: VCYT), a genomic diagnostics company focused on reducing unnecessary surgeries and healthcare costs by resolving diagnostic uncertainty, today announced that new data demonstrating the strong performance of the Afirma Gene Expression Classifier (GEC) in thyroid cancer diagnosis and its long-term impact on patient care will be presented at the AACE 26th Annual Scientific and Clinical Congress, the annual meeting of the American Association of Clinical Endocrinologists. In addition, researchers will share data validating the company's next-generation Afirma test, the Afirma Genomic Sequencing Classifier (GSC), at the meeting being held May 3-7 in Austin, Texas.

"Data from the long-term clinical utility studies to be presented at the AACE annual meeting will add to the growing body of evidence reinforcing the Afirma GEC's value and role as a new standard of care in thyroid cancer diagnosis," said Bonnie Anderson, Veracyte's chief executive officer and chairman of the board. "We are also excited to share pivotal clinical validation data demonstrating that the Afirma GSC, our next-generation Afirma test, will enable even more patients to avoid unnecessary surgery as part of thyroid nodule evaluation and diagnosis."

The following Afirma abstracts will be presented during AACE 2017:

Title:                

Reduced Surgery Through Afirma GEC Impact to Date and Potential for the Future
(Abstract #1065; poster presentation)

Presenter:        

R. Harrell, M.D., Memorial Health System

Date/Time:       

Friday, May 5, 5:00-6:15 p.m. CDT



Title:                

Six-Year Clinical and Imaging Follow Up of an Office-Based Gene Expression Classifier
Used to Manage Thyroid Nodules (Abstract #1067; oral presentation)

Presenter:        

Brian Michael, M.D., Wellspan Health

Date/Time:       

Saturday, May 6, 9:15-10:00 a.m. CDT



Title:                

A Next-Generation Gene Expression Classifier for Cytologically Indeterminate Thyroid
Nodules Derived From a Novel Sequencing Platform and Machine Learning Algorithms
with Improved Clinical Specificity: Interim Analysis (Abstract #1121; poster presentation)

Presenter:        

Paul Ladenson, M.D., Johns Hopkins University School of Medicine

Date/Time:       

Saturday, May 6, 10:00-11:00 a.m. CDT

In addition to performance data generated in the development of the Afirma GSC, which will be presented on Saturday (Poster #1121), researchers will share data from the pivotal clinical validation study for the next-generation classifier in a Veracyte Product Theater. This event will take place Thursday, May 4, from 1:15-2:00 p.m. CDT in Product Theater A.

About the Afirma GEC
The Afirma GEC is used to identify patients with benign thyroid nodules among those with indeterminate cytopathology results in order to preserve the thyroid. Each year in the United States, more than 525,000 fine needle aspiration biopsies are performed to assess patients with potentially cancerous thyroid nodules. Up to 30 percent of the results are indeterminate (not clearly benign or malignant) and physicians have traditionally recommended thyroid surgery for a more definitive diagnosis. Following surgery, however, 70 to 80 percent of patients' nodules are diagnosed as benign, meaning the surgery was unnecessary. Such surgery is invasive, costly and often leads to the need for lifelong daily thyroid hormone replacement drugs.

About Veracyte
Veracyte (NASDAQ: VCYT) is a leading genomic diagnostics company that is fundamentally improving patient care by resolving diagnostic uncertainty with evidence that is trustworthy and actionable. 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 ability to successfully scale the company and our belief that we are well positioned for profitable growth. 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 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 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 Annual Report on Form 10-K for the year ended December 31, 2016. These forward-looking statements speak only as of the date hereof and Veracyte specifically disclaims any obligation to update these forward-looking statements.

Veracyte, Afirma, Percepta, Envisia, the Veracyte logo, and the Afirma logo are trademarks of Veracyte, Inc.

 

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SOURCE Veracyte

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