Veracyte Announces New Clinical Utility Data Suggesting Envisia Genomic Classifier Enables as Confident a Diagnosis in IPF as...
November 09 2017 - 5:00PM
Business Wire
– Interim CATALYST Study Findings Presented at
PFF Summit –
Veracyte, Inc. (NASDAQ: VCYT) announced that new data for the
Envisia™ Genomic Classifier were presented today and demonstrate
that the test – in real-world clinical scenarios – can enable
diagnosis of idiopathic pulmonary fibrosis (IPF) by a central
multidisciplinary team (MDT), without the need for surgery. The
findings are important because IPF is often challenging to
distinguish from other interstitial lung diseases (ILDs) without
invasive, costly and risky surgery. The new data were shared during
the Pulmonary Fibrosis Foundation’s biannual PFF Summit, being held
November 9-11 in Nashville, Tenn.
In the interim report from the CATALYST clinical utility study,
researchers found that two central MDTs – each comprised of a
pulmonologist, radiologist and pathologist – diagnosed patients
with suspected IPF similarly (92 percent agreement) when they were
randomly assigned to review either the patients’ surgical pathology
or Envisia classifier results, along with clinical information and
high-resolution computed tomography (HRCT). The study also showed
that the Envisia classifier enabled the MDTs to agree on a
diagnosis (94 percent agreement) based on Envisia classifier
results, even when surgical pathology results were inconclusive.
The findings are from a retrospective analysis involving 71
patients who were evaluated for potential IPF using HRCT, surgical
pathology and genomic testing with the Envisia classifier.
“These findings signal a real potential for a shift in the
current diagnostic evaluation of patients undergoing evaluation for
ILD,” said Neil M. Barth, M.D., chief medical officer of Veracyte.
“Prior to the introduction of the Envisia classifier, clinicians
and patients were limited to surgery for confirming a diagnosis of
IPF, if the HRCT was inconclusive. Many patients are not willing or
medically eligible to undergo such an invasive procedure. Envisia
has now been shown to enable as confident a diagnosis in IPF as
surgical pathology. This removes many of the previous barriers to
achieving a timely and accurate diagnosis.”
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 ILD, including IPF, which is
among the most common, deadly and difficult to diagnose of these
lung-scarring diseases. Physicians routinely use 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 (UIP), a classic
diagnostic pattern whose presence is essential for the diagnosis of
IPF, using patient samples obtained through less-invasive
transbronchial biopsy.
About Veracyte
Veracyte (NASDAQ: VCYT) is a leading genomic diagnostics company
that is providing trustworthy and actionable answers that
fundamentally improve patient care when current diagnostic tests
are uncertain. 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," "expect," "believe," "should,"
"may," "will" and similar references to future periods. Examples of
forward-looking statements include, among others, our belief that
the preliminary findings signal a real potential for a shift in the
current diagnostic evaluation of patients undergoing evaluation for
ILD, our belief that use of our test may remove many of the
previous barriers to achieving a timely and accurate diagnosis, and
the applicability of clinical results to actual outcomes.
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: the final results of the CATALYST clinical utility
study; 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 September
30, 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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version on businesswire.com: http://www.businesswire.com/news/home/20171109006476/en/
Veracyte, Inc.Media:Tracy Morris,
650-380-4413tracy.morris@veracyte.comorInvestors:Jackie
Cossmon, 650-243-6371jackie@veracyte.com
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