SOUTH SAN FRANCISCO, Calif.,
May 23, 2017 /PRNewswire/
-- Veracyte, Inc. (NASDAQ: VCYT), a genomic diagnostics
company focused on reducing unnecessary surgeries and healthcare
costs by resolving diagnostic uncertainty, announced today that
pivotal clinical validation data demonstrating the performance of
its Envisia Genomic Classifier were presented at the American
Thoracic Society 2017 International Conference (ATS 2017) being held in Washington, DC. The genomic test is used to
improve diagnosis of idiopathic pulmonary fibrosis (IPF), a common
and severe form of interstitial lung disease (ILD), which is often
challenging to diagnose without surgery.
At the ATS meeting today, investigators presented pivotal
clinical validation study results confirming the Envisia
classifier's ability to detect usual interstitial pneumonia (UIP),
a pattern whose presence is essential to IPF diagnosis, without the
need for surgery. The genomic test identified UIP vs. non-UIP with
high specificity of nearly 90% and demonstrated sensitivity of 67
percent, meaning it would be expected to identify two thirds of UIP
cases with a high degree of accuracy. This performance was compared
to a reference standard of histopathology review by a central panel
of pathologists with expertise in ILD. The findings are from the
30-site, prospective BRAVE trial and involved 236 transbronchial
biopsy (TBB) samples from 49 patients.
"By providing information that today can often only be obtained
through surgery, the Envisia classifier has the potential of
enabling the diagnosis of IPF," said Ganesh Raghu, M.D., professor
of medicine in the Division of Pulmonary and Critical Care Medicine
and director of the Center for Interstitial Lung Disease at the
University of Washington and senior
author of the study. "This new molecular approach to diagnosis of
IPF will hopefully serve the patients better in ascertaining the
diagnosis of IPF."
Data were also presented from an analytical verification study
demonstrating the Envisia classifier's strong accuracy,
reproducibility, and robustness in distinguishing UIP from non-UIP
under conditions that emulate the operational and biological
variation that may be encountered in routine testing. The study
included assessing the classifier's ability to determine gene
expression in a pooled RNA sample composed of multiple (3-5) TBB
samples per patient, with varying mixtures of each sample,
illustrating that the test is robust across sampling
variations.
"The data presented today demonstrate the significant role that
the Envisia Genomic Classifier can play in resolving uncertainty in
IPF diagnosis so that patients can get the answers they need
without undergoing surgery," said Bonnie
Anderson, Veracyte's chief executive officer and chairman.
"These data also represent remarkable progress as we build the
library of clinical evidence to support physician adoption and
payer reimbursement for the test."
About Interstitial Lung Disease
Each year in
the United States and Europe, up to 200,000 patients are evaluated
for suspected interstitial lung disease (ILD), including IPF, which
is among the most common, deadly and difficult to diagnose of these
lung-scarring diseases. Physicians routinely use high-resolution
computed tomography (HRCT) to help identify IPF, but this approach
frequently provides inconclusive results, leading many patients to
undergo invasive and potentially risky surgery for a more
definitive diagnosis. Other patients are too frail to undergo
surgery and may never receive an accurate diagnosis, which can
result in suboptimal – and potentially harmful – treatment.
About the Envisia Genomic Classifier
The Envisia
Genomic Classifier is designed to improve physicians' ability to
differentiate IPF from other ILDs without the need for surgery. The
190-gene classifier uses machine learning coupled with powerful,
deep RNA sequencing to detect the presence or absence of usual
interstitial pneumonia, or UIP, a classic diagnostic pattern whose
presence is essential for the diagnosis of IPF, using samples
obtained through less-invasive bronchoscopy.
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," "expected," "can," "believe,"
"should," "may," "will" and similar references to future periods.
Examples of forward-looking statements include, among others, our
estimate of the number of patients who have avoided unnecessary
surgery, our beliefs regarding the potential benefits of our tests
to patients, physicians and payers and our beliefs regarding the
market opportunity for our products. 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: demand for our tests, 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 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; 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 March 31, 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.
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