SOUTH SAN FRANCISCO, Calif.,
Sept. 23, 2016 /PRNewswire/
-- Veracyte, Inc. (NASDAQ: VCYT) today announced new data
suggesting the potential to enhance the performance of the Afirma
Gene Expression Classifier in thyroid cancer diagnosis by combining
the test's proven RNA expression-based capabilities with gene
variant and fusion information – all on a single, robust RNA
sequencing platform. Such enhancements could help to further reduce
the number of patients who undergo unnecessary surgery when their
thyroid nodules are not clearly benign or cancerous (i.e.,
indeterminate) following routine cytopathology evaluation.
Veracyte scientists presented the findings today in a poster
session at the 86th Annual Meeting of the American
Thyroid Association, being held in Denver through September 25. Six additional posters are being
presented at the ATA meeting by external researchers and underscore
the Afirma GEC's role as a new standard of care in thyroid cancer
diagnosis.
In the Veracyte study, company researchers used RNA from 88
thyroid nodule patient samples for which a surgical pathology
diagnosis was known to train (with 58 samples) and test (with 30
samples) an enhanced version of the Afirma GEC. Using advanced
machine-learning techniques, Veracyte leveraged an RNA sequencing
platform to combine the genomic test's RNA gene expression-based
algorithm with gene variant and fusion information. The result was
an enriched classifier that yielded an overall area under curve
(AUC) of 0.88, with a sensitivity of 93 percent and a specificity
of 80 percent.
"Numerous efforts have been made to diagnose indeterminate
thyroid nodules using cancer-associated DNA mutation and fusion
information. However, research is increasingly showing the
limitations of this approach in clinical practice because such gene
alterations are found in both cancerous and benign patients," said
Giulia C. Kennedy, Ph.D., Veracyte's
chief scientific officer, who presented the new data. "We believe
that our study is the first to show that, using a powerful
machine-learning approach, RNA expression and gene variant and
fusion information can be combined into one molecular test that is
run on a single RNA sequencing platform to provide clinically
useful information. Ultimately, this should help more thyroid
nodule patients avoid unnecessary surgery. Efforts are already
underway to apply this approach to a larger study cohort."
Other Afirma GEC-related posters presented at the ATA conference
included a review of long-term outcome studies for the Afirma GEC.
Among the three studies with over a year of follow-up, the majority
of patients – 85 percent – who had Afirma GEC-benign results
following indeterminate cytopathology continued to avoid surgery
and be monitored instead. Additionally, researchers from Scripps
Clinic/Scripps Green Hospital reported that their use of the Afirma
GEC during a five-year period led to a significant reduction (23.6
percent) in surgery recommendations for indeterminate thyroid
nodules.
"Thyroid cancer has become a poster child for overtreatment in
medicine," said Bonnie Anderson,
Veracyte's president and chief executive officer. "The evidence
presented at the 2016 ATA conference shows that the Afirma GEC is
truly changing care for patients, helping them avoid surgeries they
do not need, along with the lifelong implications of that surgery,
while also removing costs from the healthcare system. We believe
our novel approach also holds promise for providing additional
clinically useful cancer-related information to physicians – in
thyroid and potentially other cancers."
More information about Veracyte's participation at the ATA
conference can be found at www.afirma.com/ata2016.
To date, Veracyte has received more than 270,000 fine needle
aspiration (FNA) patient samples and has performed over 60,000
Afirma GEC tests on those deemed inconclusive by cytopathology. The
genomic test is supported by more than 20 published studies and is
recommended in leading clinical practice guidelines. The Afirma GEC
is covered by Medicare and most leading private insurance
companies, which collectively represent approximately 185 million
Americans.
About Afirma
Among the approximately 525,000 patients who undergo an FNA
procedure each year to evaluate potentially cancerous thyroid
nodules, up to 30 percent of results are inconclusive.
Historically, most of these patients have been directed to surgery
for a more definitive diagnosis. The Afirma GEC is proven to
identify, with a high degree of accuracy (negative predictive value
of >94 percent), patients whose thyroid nodules are benign so
that they may be monitored in lieu of diagnostic surgery. The
genomic test is the core component of Veracyte's Afirma Thyroid FNA
Analysis, a comprehensive solution for improved thyroid nodule
assessment. The company's Afirma Malignancy Classifiers -
comprising tests for medullary thyroid cancer and BRAF gene
mutation status - are designed to inform surgical strategy for
those patients headed to surgery based on their cytopathology or
Afirma GEC results.
About Veracyte
Veracyte (NASDAQ: VCYT) is pioneering the field of
molecular cytology, offering genomic solutions that resolve
diagnostic ambiguity and enable physicians to make more informed
treatment decisions at an early stage in patient care. By improving
preoperative diagnostic accuracy, the company aims to help patients
avoid unnecessary invasive procedures while reducing healthcare
costs. Veracyte's Afirma® Thyroid FNA Analysis
centers on the proprietary Afirma Gene Expression Classifier (GEC)
and is becoming a new standard of care in thyroid nodule
assessment. The Afirma test is recommended in leading practice
guidelines and is covered for 185 million lives in the
United States, including
through Medicare and many commercial insurance
plans. Veracyte is expanding its molecular cytology
franchise to other clinical areas, beginning with
difficult-to-diagnose lung diseases. In 2015, the company
launched the Percepta® Bronchial Genomic
Classifier, a test to evaluate patients with lung nodules that are
suspicious for cancer, which has already received draft Medicare
coverage. In the fourth quarter of 2016, Veracyte plans to
launch its second pulmonology product, the Envisia™ Genomic
Classifier, to improve diagnosis of interstitial lung diseases
including idiopathic pulmonary fibrosis. For more information,
please visit www.veracyte.com.
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, statements we
make regarding our beliefs regarding the drivers of adoption of
Afirma, our expectations with respect to the success of our entry
into the pulmonology market, our expectations regarding full-year
2016 guidance and forecast for annual GEC test volume, and the
value and potential of our technology and research and development
pipeline. 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 limited operating history and history of
losses; our ability to increase usage of and reimbursement for
Afirma and to obtain reimbursement for any future products we may
develop or sell; our ability to continue our momentum and growth;
our dependence on a few payers for a significant portion of our
revenue; the complexity, time and expense associated with billing
and collecting from payers for our tests; laws and regulations
applicable to our business, including potential regulation by
the Food and Drug Administration or other regulatory
bodies; our dependence on strategic relationships and our
ability to successfully convert new accounts resulting from such
relationships; our ability to develop and commercialize new
products and the timing of commercialization; the size of the
market opportunity for our Percepta Bronchial Genomic Classifier;
our ability to successfully achieve adoption of and reimbursement
for our Percepta Bronchial Genomic Classifier; the amount the use
of the Percepta Bronchial Genomic Classifier is able to reduce
invasive procedures and reduce healthcare costs; our ability to
achieve sales penetration in complex commercial accounts; the
occurrence and outcome of clinical studies; the timing and
publication of study results; the applicability of clinical results
to actual outcomes; our inclusion in clinical practice guidelines;
the continued application of clinical guidelines to our products;
our ability to compete; our ability to obtain capital when needed;
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, 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