SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--May 20, 2019--
Veracyte,
Inc. (Nasdaq: VCYT), a leading genomic diagnostics company, today
announced new data demonstrating that its next-generation Percepta®
Genomic Sequencing Classifier (GSC) provides expanded lung cancer risk
information that can further guide next steps for patients with lung
nodules.
Researchers prospectively validated the Percepta GSC on 412 patients
with lung nodules who had inconclusive results following bronchoscopy, a
common nonsurgical procedure to diagnose lung cancer. Among patients
with an “intermediate” pre-test risk of cancer – the group that accounts
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 (PPV) of 65 percent when it up-classified patients to
“high risk” for cancer. The American College of Chest Physicians
recommends patients with a cancer risk of 65 percent or greater undergo
surgical treatment.
The new findings will be shared this evening at a company event being
held during the American Thoracic Society 2019 International Conference(ATS 2019) in Dallas.
“Determining whether lung nodules are benign or cancerous is often
difficult, which can lead to unnecessary invasive procedures and
treatment delays,” said Giulia C. Kennedy, Ph.D., chief scientific and
medical officer of Veracyte. “With its ability to both down-classify and
up-classify patients with inconclusive lung nodules, the Percepta GSC
should help physicians avoid invasive biopsies in patients who are at
low risk of lung cancer, while helping to guide intervention steps for
those at high risk.”
The Percepta GSC utilizes 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 also Veracyte’s third clinical classifier to be developed on the
company’s novel RNA whole-transcriptome sequencing and machine learning
platform. Veracyte plans to begin making the Percepta GSC available to
physicians by the middle of 2019.
“We are excited to unveil our Percepta GSC, which we believe will
improve diagnosis and treatment decisions for patients undergoing
evaluation for lung cancer,” said Bonnie Anderson, Veracyte’s chairman
and chief executive officer. “Additionally, we believe that moving the
Percepta classifier to our RNA whole-transcriptome sequencing platform –
together with our Afirma and Envisia classifiers – will provide
operational efficiencies and a robust foundation for continued
innovation. This includes our development of the first nasal swab test
for early lung cancer detection.”
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. Veracyte estimates
that approximately 350,000 bronchoscopies are currently performed each
year to evaluate suspicious lung nodules for cancer and that up to 70
percent of these produce inconclusive results.
Also during the ATS 2019 conference, Kevin Flaherty, M.D., of the
University of Michigan Health System, will present clinical utility data
demonstrating that Veracyte’s Envisia™ Genomic Classifier improves
diagnosis of idiopathic pulmonary fibrosis (Session D12, Abstract
A5837). These data were published online in The Lancet Respiratory
Medicine on April 1, 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 five 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:
"anticipate," "intend," "plan," "expect," "believe," "should," "may,"
"will" and similar references to future periods. Examples of
forward-looking statements include, among others, the timing by which
our Percepta GSC will be made available to physicians; and our ability
to achieve and maintain Medicare coverage for our tests, including the
Envisia Genomic Classifier. 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: 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 annual report on Form 10-Q for the quarter ended March
31, 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.
View source version on businesswire.com: https://www.businesswire.com/news/home/20190520005205/en/
Source: Veracyte
Investor & Media Contact:
Angie
McCabe
Vice President, Investor Relations & Corporate Communications
650-243-6371
angie@veracyte.com
Media Contact:
Tracy
Morris
650-380-4413
tracy.morris@veracyte.com