SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Nov. 8, 2018--
Veracyte,
Inc. (Nasdaq: VCYT) announced today the publication of “real world”
data showing that the Afirma® Genomic Sequencing Classifier (GSC)
enables even more patients to avoid unnecessary surgery in thyroid
cancer diagnosis compared to the company’s flagship, original Afirma
Gene Expression Classifier (GEC). The findings are published online in Endocrine
Practice, the journal of the American Association of
Clinical Endocrinologists.
In the study, researchers from Memorial Healthcare System in Hollywood,
Fla., reviewed data from all patients in their practice whose thyroid
nodules were deemed indeterminate (i.e., not clearly benign or
cancerous) by cytopathology review and who subsequently received results
from genomic testing with the Afirma GSC (n=139) or the Afirma GEC
(n=481). They found that the Afirma GSC identified 47 percent more
thyroid nodules as benign than the first-generation test (61.2 percent
vs. 41.6 percent). Use of the next-generation test also reduced overall
surgery rates among all patients with indeterminate thyroid nodules by
45 percent. The researchers determined that sensitivity for the Afirma
GSC in their practice was 97 percent.
The RNA sequencing-based Afirma GSC demonstrated especially strong
performance in distinguishing benign from cancerous Hürthle cells – a
category of thyroid cell that has historically been challenging to
diagnose by cytopathology or molecular methods. The Afirma GSC
identified 64.7 percent of Hürthle cell dominant biopsies as benign
compared to 17.3 percent with the original test and dramatically reduced
overall surgery referrals in this group by 57.3 percent.
“Our data suggest that the Afirma GSC is helping us to further reduce
unnecessary surgeries among our patients with indeterminate thyroid
nodules by enhancing the original test’s specificity while maintaining
its high sensitivity,” said R. Mack Harrell, M.D., cofounder of the
Memorial Center for Integrative Endocrine Surgery and lead author of the
new study. “A key reason for this change is the Afirma GSC’s ability to
rule out cancer in Hürthle-dominant thyroid nodules. This is important
because Hürthle-dominant cases comprise 22 percent of the indeterminate
thyroid nodules we evaluate.”
Dr. Harrell’s practice began using the Afirma GEC when it was introduced
in January 2011. They have been offering patients the Afirma GSC since
it became available in August 2017.
“This new publication adds to the growing body of real-world data
confirming the utility and consistent performance of the Afirma GSC
across a variety of clinical settings,” said Bonnie Anderson, Veracyte’s
chairman and chief executive officer. “Developed using a novel
combination of RNA sequencing and machine learning technology, the
Afirma GSC helps even more patients with benign thyroid nodules get
clearer answers and avoid unnecessary surgery, further benefitting them,
their physicians and the healthcare system.”
About Afirma
Veracyte’s Afirma solution provides a comprehensive offering in thyroid
cancer diagnosis for physicians evaluating patients with 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
or cancerous. 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 (Nasdaq: VCYT) is a leading genomic diagnostics company that
improves patient care by providing trustworthy and actionable answers to
challenging clinical questions. The company's products uniquely combine
advanced genomic technology, clinical science and machine learning to
provide answers that give physicians and patients a clear path forward,
informing both diagnosis and treatment decisions without the need for
costly, risky surgeries that are 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 regarding
the effectiveness of the Afirma GSC. 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: our ability to
achieve Medicare coverage for our tests, the market opportunity for the
Envisia classifier, 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 September 30, 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 and the Veracyte logo are trademarks
of Veracyte, Inc.
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Source: Veracyte
Veracyte Media & Investor Contact:
Angie McCabe,
650-243-6371
Vice President, Investor Relations & Corporate
Communications
angie@veracyte.com