SOUTH SAN FRANCISCO, Calif.,
June 27, 2017 /PRNewswire/
-- Veracyte, Inc. (NASDAQ: VCYT) announced today that results
of a study supporting the early development of the Envisia Genomic
Classifier have been published online in the Annals of the American
Thoracic Society. The genomic test, introduced commercially
in October 2016, is used to improve
the diagnosis of idiopathic pulmonary fibrosis (IPF), a common and
severe form of interstitial lung disease (ILD), which is often
challenging to diagnose without surgery.
In the study, the authors demonstrated that the initial genomic
classifier could accurately identify those patients with a
histologic pattern of usual interstitial pneumonia (UIP) without
the need for surgery. The Envisia classifier was developed
using machine learning and whole-genome RNA sequencing to identify
the genomic signature of UIP, a pattern whose presence is essential
to IPF diagnosis, from less-invasive transbronchial biopsies (TBB)
which frequently are insufficient to yield a standard
histopathology diagnosis. In the study published today,
researchers evaluated 283 TBB samples from 84 patients who were
enrolled in the prospective, multicenter BRAVE Study. They found
the classifier had a specificity of 86 percent and sensitivity of
63 percent, suggesting it could identify nearly two-thirds of UIP
cases with a high degree of accuracy. This performance was
compared to a reference standard of paired surgical samples whose
UIP/non-UIP histopathology pattern was conferred by a central panel
of three pathologists with expertise in ILD.
"These strong early results informed the development of our
commercialized Envisia Classifier, which we believe can help
significant numbers of patients with suspected IPF obtain a more
timely, accurate and safer diagnosis," said Bonnie Anderson, Veracyte's chairman and chief
executive officer. "These newly published findings also reinforce
the scientific and clinical rigor that went into the Envisia
Classifier's development. We believe that this foundational work,
along with the robust clinical validation data we have shared in
recent months, will build the body of published evidence needed to
drive physician adoption and payer reimbursement of the Envisia
Genomic Classifier test."
At the recent American Thoracic Society 2017 International
conference, investigators presented results of the pivotal clinical
validation study showing that the commercialized version of the
Envisia Classifier detected even higher specificity and sensitivity
than the early prototype classifier data published today.
About Interstitial Lung Disease and Idiopathic Pulmonary
Fibrosis
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 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 beliefs
regarding the potential benefits of our tests to patients,
physicians and payers, our beliefs regarding the scientific and
clinical rigor that went into the Envisia Classifier's development
and our beliefs regarding our ability to build the body of
published evidence needed to drive physician adoption and payer
reimbursement for the test. 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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SOURCE Veracyte