Novel genomic test distinguishes IPF from other lung-scarring
diseases without the need for surgery
SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Apr. 1, 2019--
Veracyte,
Inc. announced that data published online today in The
Lancet Respiratory Medicine suggest that use of the company’s
Envisia Genomic Classifier improves diagnosis for patients undergoing
evaluation for interstitial lung diseases (ILDs), including idiopathic
pulmonary fibrosis (IPF). The Envisia classifier is the first
commercially available test that may help distinguish IPF from other
ILDs, without the need for risky surgery. The Envisia classifier
recently received Medicare
coverage, making it the first test of its kind for improving IPF
diagnosis to be covered for the nation’s 55 million Medicare patients.
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.
“IPF is often challenging to distinguish from other ILDs, but timely and
accurate diagnosis is critical so that patients with IPF can access
therapies that may slow progression of the disease, while avoiding
potentially harmful treatments,” said Ganesh Raghu, M.D., Director,
Center for Interstitial Lung Diseases, and Professor of Medicine at the
University of Washington and lead author of the new paper. “Our results
with molecular classification through machine learning (the Envisia
classifier) are promising and, along with clinical information and
radiological features in high-resolution CT imaging, physicians through
multidisciplinary discussions, may be able to utilize the molecular
classification as a diagnostic tool to make a more informed and
confident diagnoses.”
The new paper includes data from a clinical validation and a clinical
utility study, both conducted using data from patients enrolled in the
ongoing, prospective, 29-site, blinded BRAVE (Bronchial Sample
Collection for a Novel Genomic Test) study. The clinical validation
study assessed the Envisia classifier’s ability to identify the usual
interstitial pneumonia (UIP) pattern, whose presence is essential to IPF
diagnosis. Among 49 patients who met the study criteria (and were not
used to train the genomic classifier algorithm), the Envisia classifier
achieved a specificity of 88 percent and sensitivity of 70 percent for
UIP. These findings mean that the test would be expected to identify
more than two-thirds of UIP cases with a high degree of accuracy, while
minimizing the number of false positive results, providing physicians
with greater confidence in their diagnosis. In comparison, data show
that high-resolution CT (HRCT) imaging, which is typically used in IPF
diagnosis, has a sensitivity of just 43 percent for UIP.
In the clinical utility study, known as CATALYST (Clinical Utility
Analysis of a UIP Genomic Classifier in the BRAVE Trial), two
multidisciplinary teams (MDTs) conducted blinded reviews of 94 study
participants’ medical charts. Researchers found that when the Envisia
classifier was used as a complement to HRCT in an MDT evaluation, there
was high agreement (86 percent) in IPF versus non-IPF diagnoses when
evaluating the same patients with HRCT and surgical histopathology
results. Further, when both MDTs made an IPF diagnosis, the authors
observed that the MDT with Envisia classifier results was significantly
more confident in its IPF diagnosis compared to the team with surgical
histopathology results (89 percent versus 56 percent).
“These findings show that, when paired with HRCT results and patient
clinical history, the Envisia classifier gave physicians a higher level
of confidence in making an IPF diagnosis,” said Sadia Benzaquen, M.D.,
director of interventional pulmonology at UC Health in Cincinnati, Ohio,
and an author of the paper.
“The data published today underscore the performance and significant
value that the Envisia Genomic Classifier brings to physicians, patients
and the healthcare system,” said Bonnie Anderson, chairman and chief
executive officer of Veracyte. “We believe our test has the potential to
transform the diagnosis of IPF and other ILDs. More immediately, this
new paper, combined with the Medicare coverage policy for the Envisia
classifier issued recently, will fuel our efforts to make the classifier
more widely available to the patients across the country who can benefit
from it.”
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.
About Envisia
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
surgery. In August 2018, the Centers for Medicaid & Medicare Services
issued a draft Medicare coverage policy for the Envisia classifier and a
final coverage decision is expected in early 2019.
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. 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:
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forward-looking statements include, among others, our ability to achieve
and maintain Medicare coverage 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
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VCYT-E
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Source: Veracyte, Inc.
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