Novel Genomic Test Helps Improve Diagnosis of Idiopathic Pulmonary
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Apr. 22, 2019--
Inc. (Nasdaq: VCYT), a leading genomic diagnostics company,
announced today that it has received regulatory authorization from the
New York State Department of Health to offer the Envisia™ Genomic
Classifier for patients in the state effective immediately. The genomic
test is the first commercially available test to help distinguish
idiopathic pulmonary fibrosis (IPF) from other interstitial lung
diseases (ILD), without the need for risky surgery.
“We are pleased that the Envisia classifier will now be available to
physicians and their patients in New York State,” said Bonnie Anderson,
Veracyte’s chairman and chief executive officer. “This milestone, along
with a recent Medicare coverage policy, underscores the strength of the
clinical evidence behind the Envisia classifier and the critical need
for better diagnosis among patients being evaluated for ILDs, including
Over 100,000 people in the United States have lung-scarring ILDs,
including IPF, which is the deadliest type, and the number is rising.
While therapies are now available to slow progression of this deadly
disease, 55 percent of IPF/ILD patients reported being misdiagnosed at
least once and, for one in five patients, accurate diagnosis took three
or more years, according to a study by the Pulmonary Fibrosis Foundation.
Earlier this month, clinical validation and clinical utility data for
the Envisia classifier were published in The
Lancet Respiratory Medicine, demonstrating the test’s
ability to identify the telltale pattern of IPF, while minimizing false
positive results, and its usefulness in giving physicians more
confidence in their diagnosis of patients being evaluated for
interstitial lung disease, including IPF, without the need for surgery.
The Envisia classifier is used as a complement to high-resolution
computed tomography (HRCT).
About Interstitial Lung Disease
Each year in the United States and Europe, up to 200,000 patients are
evaluated for suspected interstitial lung disease, including idiopathic
pulmonary fibrosis, which is among the most common, deadly and difficult
to diagnose of these lung-scarring diseases. Physicians routinely use
high-resolution computed tomography (HRCT) along with a clinical work-up
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.
The Envisia Genomic Classifier is the first commercially available test
to improve the diagnosis of idiopathic pulmonary fibrosis (IPF). The
genomic test enables physicians to more confidently differentiate IPF
from other interstitial lung diseases (ILD), helping to guide an optimal
patient treatment plan that can improve outcomes and reduce risk. The
Envisia classifier was developed using RNA whole-transcriptome
sequencing and machine learning to identify the usual interstitial
pneumonia (UIP) pattern, which is a hallmark of IPF. The test assesses
patient samples obtained through bronchoscopy, a nonsurgical procedure
commonly used in lung evaluation, and is used as a complement to
high-resolution computed tomography (HRCT). The Envisia classifier is
proven to detect UIP with high correlation to the gold standard –
histopathology results read by ILD experts – without the need for
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. 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 achieve
and maintain coverage from Medicare and state authorities for our tests,
including the Envisia Genomic Classifier; the expected impacts of
Veracyte’s collaboration with Johnson & Johnson in developing
interventions for lung cancer, on Veracyte’s financial and operating
results, on the timing of the commercialization of the Percepta
classifier, and on the size of Veracyte’s addressable market.
Forward-looking statements are neither historical facts nor assurances
of future performance, but are based only on our current beliefs,
expectations and assumptions. These statements involve risks and
uncertainties, which could cause actual results to differ materially
from our predictions, and include, but are not limited to: our ability
to achieve milestones under the collaboration agreement with Johnson &
Johnson; the benefits of our tests and 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 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 annual report on Form 10-K for the year ended December
31, 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, Inc.
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