Veracyte Announces Clinical Data Demonstrating Clinical Validity & Utility of Percepta Classifier in Lung Cancer Diagnosis Wh...
October 21 2019 - 4:15PM
Business Wire
Data Being Presented at CHEST Annual Meeting
2019
Veracyte, Inc. (Nasdaq: VCYT) today announced data demonstrating
the clinical validity of its next-generation Percepta® Genomic
Sequencing Classifier (GSC) and the clinical utility of its
first-generation test in a real-world setting in improving lung
cancer diagnosis when bronchoscopy results are inconclusive. The
findings will be presented on Thursday, October 23, at the annual
meeting of the American College of Chest Physicians® (CHEST) in New
Orleans.
“These data confirm the performance of our Percepta classifier
and its ability to guide care for lung nodule patients when
bronchoscopy findings are inconclusive,” said Bonnie H. Anderson,
Veracyte’s chairman and chief executive officer. “We have been
especially pleased by physicians’ positive response to our
next-generation Percepta GSC, which we introduced in June of this
year and which provides expanded information to physicians.”
For the first study, researchers prospectively validated the
Percepta GSC on a blinded, independent set of 412 samples from
patients with lung nodules that were referred for bronchoscopy
evaluation. Among a subset of patients with low or intermediate
pre-test risk for whom malignancy was confirmed, the Percepta GSC
significantly improved sensitivity for lung cancer detection in
combination with bronchoscopy (95.5 percent), compared to
bronchoscopy alone (40.9 percent). The genomic classifier
demonstrated improved sensitivity compared to bronchoscopy
regardless of nodule size or location or cancer subtype.
Among a subset of 188 patients with an intermediate pre-test
risk of cancer, which account for the majority of lung nodules, the
Percepta GSC demonstrated high accuracy when it down-classified
patients to “low risk” for cancer (negative predictive value of 91
percent). The test also had a positive predictive value of 65
percent when it up-classified patients to “high risk” for cancer.
The American College of Chest Physicians recommends that patients
with a low risk of cancer undergo monitoring with CT imaging and
that patients with a cancer risk of 65 percent or greater undergo
surgical treatment.
“Bronchoscopy is often used to evaluate potentially cancerous
lung nodules because it offers a nonsurgical way to detect lung
cancer. However, bronchoscopy results are often inconclusive, which
leaves physicians with a dilemma of whether to direct the patient
for more invasive procedures or just monitor them with imaging at
the risk of missing a cancer,” said Giulia C. Kennedy, Ph.D., chief
scientific officer and chief medical offer for Veracyte, who was a
researcher in the study. “Our findings suggest that use of the
Percepta GSC can improve the performance of bronchoscopy, making it
a potentially more useful diagnostic tool that can help lung nodule
patients at low risk for cancer avoid unnecessary invasive
procedures or those at high risk get more timely treatment.”
The next-generation Percepta GSC was developed on Veracyte’s RNA
whole-transcriptome sequencing and machine learning platform and is
based on novel “field of injury” science – which identifies genomic
changes associated with lung cancer in current or former smokers
using a simple brushing of the person’s airway. The test is
performed on a sample from the patient’s main lung airway, which is
collected during a bronchoscopy. Veracyte estimates that
approximately 360,000 bronchoscopies are currently performed each
year to evaluate suspicious lung nodules for cancer and that up to
60 percent of these produce inconclusive results.
A second, independent study is being presented at the CHEST
meeting by researchers from LAC+USC Medical Center, a county
hospital in Los Angeles, on their experience using the original
Percepta classifier.
Lung cancer is the leading cause of cancer deaths worldwide. In
the United States, lung cancer causes more than 154,000 deaths each
year – more than the next three most prevalent cancers combined.
Because lung cancer is difficult to diagnose before it has
metastasized, only 16 percent of cases are detected at an early
stage, when the disease is more treatable. Lung cancer’s five-year
survival rate is only 18 percent, much lower than that of other
common cancers. Approximately 80 percent of lung cancer deaths are
caused by smoking.
About Veracyte
Veracyte (Nasdaq: VCYT) is a leading genomic diagnostics company
that improves patient care by providing answers to clinical
questions that inform diagnosis and treatment decisions without the
need for costly, risky surgeries that are often unnecessary. The
company's products uniquely combine RNA whole-transcriptome
sequencing and machine learning to deliver results that give
patients and physicians a clear path forward. Since its founding in
2008, Veracyte has commercialized seven genomic tests and is
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: "anticipate," "intend," "plan," "expect," "believe," "should,"
"may," "will" and similar references to future periods. Examples of
forward-looking statements include, among others, the ability of
Percepta to improve the diagnosis of lung cancer. Forward-looking
statements are neither historical facts nor assurances of future
performance, but are based only on our current beliefs,
expectations and assumptions. These statements involve risks and
uncertainties, which could cause actual results to differ
materially from our predictions, and include, but are not limited
to: our ability to achieve milestones under the collaboration
agreement with Johnson & Johnson; our ability to achieve and
maintain Medicare coverage for our tests; the benefits of our tests
and 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 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, 2019. 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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version on businesswire.com: https://www.businesswire.com/news/home/20191021005577/en/
Investors: Keith Kennedy Chief Operating Officer and
Chief Financial Officer keith@veracyte.com 650-243-6357
Media: Tracy Morris tracy.morris@veracyte.com
650-380-4413
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