SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Oct. 8, 2018--
Veracyte,
Inc. (Nasdaq: VCYT) announced the presentation of data demonstrating
that the Envisia Genomic Classifier can help physicians more confidently
diagnose interstitial lung disease (ILD), including idiopathic pulmonary
fibrosis (IPF), without the need for surgery. The data were shared today
in an oral presentation at CHEST 2018, the annual meeting of the
American College of Chest Physicians®, which is being
held October 6-10 in San Antonio, Texas.
Using data from a prospective study of 49 patients presenting with
new-onset ILD, researchers evaluated samples obtained through
nonsurgical transbronchial biopsy to determine the Envisia classifier’s
accuracy in detecting usual interstitial pneumonia (UIP), a pattern
whose presence is essential to IPF diagnosis. Utilizing histopathology
as the reference standard, investigators found that the genomic test
shows a specificity of 88 percent and sensitivity of 70 percent for
detecting UIP. While high-resolution computed tomography (HRCT) is
typically the first step in distinguishing IPF from other ILDs, previous
data have shown that up to 50 percent of UIP cases are missed by HRCT
alone. Among the 42 cases in the current study with the lowest
diagnostic confidence following HRCT – i.e., those without definite or
probable UIP – the Envisia classifier provided even more robust results
(88 percent specificity and 76 percent sensitivity).
“An accurate, timely diagnosis of IPF and other ILDs is a major
challenge for physicians and patients, but is essential for optimal
treatment,” said David Lynch, MB, BCh, Professor of Radiology at
National Jewish Health, who presented the findings. “Our data, while
based on relatively small numbers, suggest that the Envisia test can
provide important information for diagnosis, as a complement to HRCT and
clinical findings. This is particularly true among patients whose
results are unclear following HRCT imaging.”
“Recent study findings show that patients being evaluated for suspected
IPF or other ILDs often endure significant diagnostic delays,
misdiagnosis and invasive, costly procedures, which can negatively
impact outcomes and increase risk,” said Bonnie Anderson, Veracyte’s
chairman and chief executive officer. “These new data reinforce the
valuable role that the Envisia Genomic Classifier can play in improving
IPF diagnosis. They also add to the growing body of evidence supporting
the use of our test.”
The Envisia classifier is currently available to a limited number of
institutions through an Early Access Program. In August 2018, Veracyte
received a draft Medicare coverage policy for the Envisia classifier
through the MolDx program. The company expects the final policy will go
into effect in early 2019 and plans to expand availability of the test
in 2019.
About Interstitial Lung Disease
Each year in the United States and Europe, up to 200,000 patients are
evaluated for suspected ILD, including IPF, which is among the most
common, deadly and difficult to diagnose of these lung-scarring
diseases. Physicians routinely use 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.
About Envisia
The Envisia Genomic Classifier is the first commercially available test
to improve the diagnosis of idiopathic pulmonary fibrosis (IPF). The
Envisia 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
classifier works by harnessing the power of RNA sequencing and machine
learning to detect a genomic pattern of usual interstitial pneumonia
(UIP), whose presence is required for IPF diagnosis. The Envisia test is
proven to detect UIP with high correlation to the gold standard –
histopathology results read by ILD experts – without the need for
surgery.
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 that our
genomic tests will transform the diagnosis of thyroid cancer, lung
cancer and idiopathic pulmonary fibrosis; statements regarding the
ability of the Envisia Genomic Classifier to reduce the need for
invasive procedures in and improve IPF diagnosis; and statements
regarding the draft and any final Medicare coverage policy for the
Envisia Genomic Classifier. 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 June 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, Inc.
Veracyte Media & Investor Contact:
Angie McCabe,
650-243-6371
Vice President, Investor Relations & Corporate
Communications
angie@veracyte.com