SOUTH SAN FRANCISCO, Calif.,
Oct. 25, 2016 /PRNewswire/ --
Veracyte, Inc. (NASDAQ: VCYT), a genomic diagnostics company that
reduces unnecessary surgeries and healthcare costs by resolving
diagnostic uncertainty, announced the launch of the Envisia Genomic
Classifier at the CHEST Annual Meeting 2016 in Los Angeles. Envisia is expected to be the
first commercially available test to help patients with suspected
idiopathic pulmonary fibrosis (IPF) secure accurate diagnoses more
quickly than the currently available process and without the need
for invasive surgery.
Each year in the United States
and Europe, up to 200,000 patients
are suspected of having an interstitial lung disease (ILD),
including IPF, which is among the most common and most deadly of
these lung-scarring diseases. IPF is notoriously difficult to
diagnose, often leading to treatment delays, repeated misdiagnoses,
patient distress and added healthcare expense. Veracyte estimates
that by helping to improve care for these patients, the company is
targeting a $500 million market in
the United States and Europe.
The Envisia 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
that is essential for the diagnosis of IPF. Physicians routinely
use high-resolution CT imaging (HRCT) to identify UIP, but this
approach frequently provides inconclusive results, leading many
patients to undergo surgery to secure a more definitive diagnosis
using surgical histopathology. Veracyte scientists trained the
Envisia classifier to differentiate UIP from non-UIP on patient
samples obtained through less-invasive outpatient bronchoscopy.
During a private event with leading pulmonologists and other
IPF-treating physicians at CHEST 2016, Giulia C. Kennedy, Ph.D., chief scientific
officer of Veracyte, presented data demonstrating the clinical
validity of the Envisia classifier. The test was trained on over
350 samples obtained through bronchoscopy from 90 patients
participating in the ongoing, prospective 30-site BRAVE study. The
researchers then evaluated the clinical validity of the locked
190-gene classifier using an independent set of samples from 49
BRAVE study participants, confirming that Envisia detects UIP vs.
non-UIP with high specificity (88 percent). The classifier reported
sensitivity of 67 percent, meaning it would be expected to identify
nearly two-thirds of UIP cases. These results show high concordance
with the presence or absence of a UIP pattern reported on surgical
histopathology review by a centralized panel of pathologists with
expertise in ILD.
"The availability of a clinically validated genomic classifier
for patients with suspected IPF will be a significant step forward
in ensuring an accurate and timely diagnosis," said Ganesh Raghu,
M.D., professor of medicine in the Division of Pulmonary and
Critical Care Medicine and director of the Center for Interstitial
Lung Disease at the University of
Washington. "In the current diagnostic pathway, an accurate
diagnosis may require a surgical lung biopsy to confirm the
presence of UIP. This is an invasive, costly and potentially risky
procedure."
"Patients with suspected ILD, including IPF, endure a
significant delay in diagnosis, frequent misdiagnosis and often
require invasive procedures to get definitive answers," said
Gregory Cosgrove, M.D., associate
professor of medicine, National Jewish Health and CEO of the
Pulmonary Fibrosis Foundation (PFF). "Better tools are needed to
reduce the clinical impact, anxiety and cost involved in an IPF
diagnosis. Based on the clinical validity data shared here this
week, the Envisia classifier could help to fill this compelling,
unmet need."
Veracyte will begin making the Envisia Genomic Classifier
available to a limited number of institutions in December, as the
company builds the clinical evidence it believes will be necessary
to support Medicare reimbursement. This strategic roll out follows
the successful commercialization and reimbursement approach that
the company used with its tests in thyroid cancer
(Afirma® Gene Expression Classifier) and lung cancer
(Percepta® Bronchial Genomic Classifier).
"Veracyte now has three commercial products in major disease
markets that we estimate to be more than $2
billion," said Bonnie
Anderson, president and chief executive officer of Veracyte.
"The Envisia classifier is a further demonstration of our
commitment to significantly improve patient care by reducing
diagnostic uncertainty. We believe it is the first clinically
available test to combine deep RNA sequencing with machine learning
algorithms, and it serves as an excellent demonstration of our
ability to push the limits of genomic science to create novel,
valuable diagnostic tools that change clinical care."
About Veracyte
Veracyte (NASDAQ: VCYT) is pioneering the field of
molecular cytology, offering genomic solutions that resolve
diagnostic ambiguity and enable physicians to make more informed
treatment decisions at an early stage in patient care. By improving
preoperative diagnostic accuracy, the company aims to help patients
avoid unnecessary invasive procedures while reducing healthcare
costs. Veracyte's Afirma® Thyroid FNA Analysis
centers on the proprietary Afirma Gene Expression Classifier (GEC)
and is becoming a new standard of care in thyroid nodule
assessment. The Afirma test is recommended in leading practice
guidelines and is covered for 185 million lives in the
United States, including
through Medicare and many commercial insurance
plans. Veracyte is expanding its molecular cytology
franchise to other clinical areas, beginning with
difficult-to-diagnose lung diseases. In 2015, the company
launched the Percepta® Bronchial Genomic
Classifier, a test to evaluate patients with lung nodules that are
suspicious for cancer, which has already received draft Medicare
coverage. In October 2016,
Veracyte launched its second pulmonology product, the Envisia™
Genomic Classifier, to improve diagnosis of interstitial lung
diseases, including idiopathic pulmonary fibrosis. For more
information, please visit www.veracyte.com.
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, statements we
make regarding the benefits of Envisia to patients, physicians and
payers, our belief that the use of the Percepta classifier helps
reduce surgery and other costly procedures, our belief that the
availability of the company's test is an advance toward ensuring
more accurate and timely diagnoses, the limitations of current
diagnostic procedures, the company's belief that it will be able to
build the clinical evidence necessary to support Medicare
reimbursement for its test, the company's belief that Envisia is
the first clinically available test of its kind, our belief that
the test demonstrates the company's ability to push the limits of
genomic science to create novel tools that change clinical care,
the applicability of clinical results to actual outcomes, and the
company's beliefs regarding the potential markets for Envisia and
the company's other products . 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 ability of Envisia to change
physicians' practices; 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 adoption of and reimbursement for Envisia; 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 June 30,
2016. 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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