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
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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