Veracyte, Inc.
Oct 5, 2017

Veracyte Announces Data From Five Studies Validating the Next-Generation Afirma Genomic Sequencing Classifier to Be Presented at ATA 2017 Annual Meeting

SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)-- Veracyte, Inc. (NASDAQ: VCYT) today announced that data from five studies validating the performance of the next-generation Afirma® Genomic Sequencing Classifier (GSC) in thyroid cancer diagnosis will be presented at the 87th Annual Meeting of the American Thyroid Association (ATA) being held October 18-22 in Victoria, BC, Canada. Two oral and three poster presentations will demonstrate the Afirma GSC's ability to further reduce unnecessary surgeries in thyroid cancer diagnosis while providing physicians information to enable more appropriate treatment when suspicious nodules are identified.

"We believe the results of these studies highlight the Afirma GSC's unique ability to provide physicians with answers, including answers to the most challenging biological questions, as they evaluate patients for thyroid cancer," said Bonnie Anderson, Veracyte's chairman and chief executive officer. "These data reinforce our commitment to develop the extensive clinical evidence required to gain both physicians' and patients' confidence in using our genomic tests to inform important patient-care decisions."

Data from two studies evaluating the Afirma GSC's performance in two of the most challenging thyroid biologies will be shared as oral presentations at the ATA meeting:

Title:

     

Development and Validation of Classifiers to Enhance the Afirma Genomic Sequencing Classifier Performance Among Hürthle Cell Specimens (Short Call Oral Abstract #6)

Presenter:

Quan-Yang Duh, M.D., University of California, San Francisco

Date/Time:

Saturday, October 21, 8:50-9:50 a.m.*

Location:

Victoria Conference Center, Salon AB

Title:

      Clinical Validation of the Afirma Genomic Sequencing Classifier for Medullary Thyroid Cancer (Oral Abstract #29)

Presenter:

Gregory Randolph, M.D., Massachusetts Eye and Ear Infirmary

Date/Time:

Saturday, October 21, 3:20-4:50 p.m.

Location:

Victoria Conference Center, Salon AB
 

The following abstracts will be presented as posters:

Title:

      Clinical Validation of the Afirma Genomic Sequencing BRAF V600E Classifier (Poster 167)

Presenter:

Trevor E. Angell, M.D., Brigham and Women's Hospital

Date/Time:

Thursday, October 19, 9:50-10:45 a.m. and 3:05-4:00 p.m.

Location:

Victoria Conference Center, Crystal Garden ATA Exhibit Hall

Title:

      Clinical Validation of the Afirma Genomic Sequencing Parathyroid Classifier (Poster 168)

Presenter:

Julie Ann Sosa, M.D., Duke University

Date/Time:

Thursday, October 19, 9:50-10:45 a.m. and 3:05-4:00 p.m.

Location:

Victoria Conference Center, Crystal Garden ATA Exhibit Hall

Title:

      Analytical Performance of Afirma GSC: A Genomic Sequencing Classifier for Cytology-Indeterminate Thyroid Nodule FNA Specimens (Short Call Poster 43)

Presenter:

Zhanzhi Hu, Ph.D., Veracyte, Inc.

Date/Time:

Friday, October 20, 9:50-10:45 a.m. and 3:05-4:00 p.m.

Location:

Victoria Conference Center, Crystal Garden ATA Exhibit Hall
 

* All Pacific Time

Veracyte also will host a Product Theater event, "The New Afirma Genomic Sequencing Classifier - Leveraging Enriched Genomic Data through RNA Sequencing and Advancements in Machine Learning to Identify More Benign Thyroid Nodules," on Thursday, October 19, 3:05 p.m.- 4:00 p.m. Pacific Time in the Victoria Conference Center Oak Bay Expo Theater.

About Afirma

The Afirma Genomic Sequencing Classifier is the next-generation version of the Afirma Gene Expression Classifier, and 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 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 Afirma GSC's ability to further reduce unnecessary surgeries in thyroid cancer diagnosis while providing physicians information to enable more appropriate treatment when suspicious nodules are identified, our beliefs with respect to the results of the studies, including Afirma GSC's ability to provide answers to the most challenging biological questions in evaluating patients, our commitment to developing extensive clinical evidence required to generate confidence in our products, 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 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 ability of our products to change treatment decisions and reduce unnecessary surgeries; 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 June 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.

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

Veracyte, Inc.
Media:
Tracy Morris, 650-380-4413
tracy.morris@veracyte.com
or
Investors:
Jackie Cossmon, 650-243-6371
jackie@veracyte.com

Source: Veracyte, Inc.

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