SOUTH SAN FRANCISCO, Calif.,
May 11, 2017 /PRNewswire/
-- Veracyte, Inc. (NASDAQ: VCYT), a genomic diagnostics
company focused on reducing unnecessary surgeries and healthcare
costs by resolving diagnostic uncertainty, announced that data
demonstrating the cost-effectiveness of the Percepta Bronchial
Genomic Classifier were published for the first time today in the
Journal of Thoracic Oncology (JTO). These data suggest that
use of the Percepta classifier in lung cancer screening and
diagnosis can meaningfully reduce invasive procedures and
associated costs, and is cost-effective across a range of
assumptions.
The Percepta classifier is used to resolve inconclusive
bronchoscopy results in patients undergoing evaluation for
potentially cancerous lung nodules or lesions. Among the estimated
350,000 patients who undergo such a bronchoscopy each year, up to
70 percent receive results that are inconclusive. This frequently
leads to patients undergoing potentially risky, expensive and
unnecessary invasive procedures, including transthoracic needle
biopsy (TTNB) and surgical lung biopsy (SLB), to obtain a more
definitive diagnosis.
"Unnecessary invasive procedures in lung cancer diagnosis can
expose patients to procedural risks and discomfort, and create an
additional cost burden to the healthcare system," said David Feller-Kopman, M.D., associate professor
of medicine at the Johns Hopkins School of
Medicine, and lead author on the JTO paper. "Our
findings suggest that use of the Percepta classifier can
significantly reduce unnecessary procedures in a cost-effective
manner, making it a high-value strategy for the diagnostic work-up
of patients with possible lung cancer."
To conduct their analysis, Dr. Feller-Kopman and colleagues
evaluated data for 101 lung-nodule patients from the multicenter,
prospective AEGIS-1 and -2 studies, which investigated the clinical
performance of the Percepta classifier. All patients had a pre-test
intermediate risk of lung cancer based on clinical factors. Using a
commonly accepted health economics framework (a Markov model), they
found that use of the Percepta classifier following an inconclusive
bronchoscopy reduced invasive procedure rates by 28 percent at one
month and 18.3 percent at two years, compared to use of
bronchoscopy alone. They also found that the incremental
cost-effectiveness ratio (ICER) – the primary metric used in health
economics to assess the value of an intervention – was $15,052 per quality-adjusted life years (QALY).
According to the authors, ICER values up to $50,000 per QALY are considered "good value."
"These new data underscore the tremendous value that the
Percepta classifier brings to patients and the healthcare system by
reducing unnecessary invasive procedures in lung cancer screening
and diagnosis," said Bonnie
Anderson, chief executive officer and chairman of Veracyte.
"They also reinforce our commitment to providing genomic tests that
answer clear clinical questions and have a direct impact on
physicians' patient-care decision making."
About Percepta
The Percepta Bronchial Genomic
Classifier is the first genomic test to receive Medicare coverage
for improved safety and accuracy in lung cancer screening and
diagnosis. The 23-gene classifier identifies patients with lung
nodules who are at low risk of cancer following an inconclusive
bronchoscopy result, making it possible to monitor these patients
with CT scans in lieu of invasive diagnostic procedures. The
Percepta classifier's performance is proven in clinical validation
studies enrolling more than 1,000 patients, including strong data
published in The New England Journal of Medicine. The
classifier uses proprietary genomic technology to detect molecular
changes that occur in the epithelial cells lining the lung's
respiratory tract in current or former smokers with lung cancer.
These changes can be detected in cells obtained from standard
cytology brushings taken during bronchoscopy from the mainstem
bronchus, and indicate the presence of malignancy or disease
processes from distant sites in the lung. Thus, the test is
designed to determine a lung nodule's or lesion's likelihood of
cancer, without the need to sample the nodule or lesion directly.
The Percepta classifier is performed at Veracyte's CLIA-certified
laboratory in South San Francisco,
California. For more information, view the Percepta
video.
About Veracyte
Veracyte (NASDAQ: VCYT) is a
leading genomic diagnostics company that is fundamentally improving
patient care by resolving diagnostic uncertainty with evidence that
is trustworthy and actionable. 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 ability to
successfully scale the company and our belief that we are well
positioned for profitable growth. 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 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 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 March 31,
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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SOURCE Veracyte