Veracyte, Inc. (Nasdaq: VCYT) announced today the publication of
a new study that demonstrates the robust performance of the
Percepta Genomic Sequencing Classifier (GSC), a novel genomic test,
in helping to improve lung cancer diagnosis. The data, based on
widely accepted community guidelines for establishing analytical
validity, add to the growing body of clinical evidence supporting
the use of the Percepta GSC to guide next steps for patients with
lung nodules whose bronchoscopy results are inconclusive. The
peer-reviewed paper appears online in the journal BMC Cancer.
Veracyte scientists followed criteria established by the
Evaluation of Genomic Applications in Practice and Prevention
(EGAPP) Working Group and the Centers for Disease Control’s ACCE
Project to evaluate the analytical validity of the Percepta GSC.
They also assessed the Percepta GSC for reproducibility within and
across laboratories.
Based on the guidelines, the scientists determined the Percepta
GSC test is suitable for routine clinical use with robust
analytical sensitivity, analytical specificity, and
reproducibility. Expected variability in clinical laboratories —
assessed in this study by using different instruments, operators,
and labs — was found to be negligible.
“We are pleased to share the results of this analytical
validation study, which clearly demonstrate the Percepta GSC’s
robust performance regardless of variations in RNA quantity, as
well as the presence of blood or other contaminants, in patient
samples,” said Giulia C. Kennedy, Ph.D., Veracyte’s chief
scientific officer and chief medical officer, and an author of the
study. “These findings should give physicians further confidence
that the Percepta GSC can help them determine next steps for their
lung-nodule patients when bronchoscopy results are
inconclusive.”
About the Percepta GSC The Percepta GSC is an RNA
sequencing-based risk-stratification test designed to aid patient
management in cases where a lung nodule is present and bronchoscopy
results are unclear. Veracyte estimates that approximately 545,000
bronchoscopies are performed each year to evaluate suspicious lung
nodules and that up to 60 percent of these produce inconclusive
results. The Percepta GSC is based on novel “field of injury”
science, which identifies genomic changes that correlate with lung
cancer risk in current or former smokers using a brushing to
collect cells from the patient’s main lung airway during a standard
bronchoscopy, without the need to sample the lesion directly.
Previous analyses demonstrated the test’s accuracy in
“down-classifying” patients at low risk of lung cancer and in
“up-classifying” patients at high risk of the disease.1 The test
has been commercially available since June 2019.
About Lung Cancer Lung cancer kills more than 1.75
million people worldwide each year.2 Early detection is key, with a
five-year survival rate of nearly 60 percent when the cancer is
found early, compared to six percent when it is found at a later
stage.3 Lung nodules are typically the first sign of lung cancer.
Bronchoscopy is commonly used to evaluate potentially cancerous
lung nodules, but it often delivers inconclusive results. This
frequently leads to additional diagnostic procedures, including
invasive lung surgeries, as well as delayed diagnosis and
treatment.
About Veracyte Veracyte (Nasdaq: VCYT) is a global
genomic diagnostics company that improves patient care by providing
answers to clinical questions, informing diagnosis and treatment
decisions throughout the patient journey in cancer and other
diseases. The company’s growing menu of genomic tests leverage
advances in genomic science and technology, enabling patients to
avoid risky, costly diagnostic procedures and quicken time to
appropriate treatment. The company’s tests in lung cancer, prostate
cancer, breast cancer, thyroid cancer, bladder cancer and
idiopathic pulmonary fibrosis are available to patients and its
lymphoma subtyping and renal cancer tests are in development. With
Veracyte’s exclusive global license to a best-in-class diagnostics
instrument platform, the company is positioned to deliver its tests
to patients worldwide. 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, including, but
not limited to, our statements related to our plans, objectives,
expectations (financial and otherwise) or intentions with respect
to the Percepta Genomic Sequencing Classifier. Forward-looking
statements can be identified by words such as: "anticipate,"
"intend," "plan," "expect," "believe," "should," “suggest,” "may,"
"will" and similar references to future periods. Actual results may
differ materially from those projected or suggested in any
forward-looking statements. Examples of forward-looking statements
include, among others, statements regarding Veracyte’s belief that
its Percepta GSC test provides clinical value that helps physicians
diagnose and treat lung cancer. These statements involve risks and
uncertainties, which could cause actual results to differ
materially from our predictions, and include, but are not limited
to: Veracyte’s ability to achieve and maintain Medicare coverage
for its tests; the benefits of Veracyte’s tests and the
applicability of clinical results to actual outcomes. Additional
factors that may impact these forward-looking statements can be
found under the caption “Risk Factors” in our Annual Report on Form
10-K filed with the SEC on February 22, 2021 and our subsequent
quarterly reports on Form 10-Q. A copy of these documents can be
found at the Investors section of our website at www.veracyte.com.
The risks and uncertainties may be amplified by the COVID-19
pandemic, which has caused significant economic uncertainty. The
extent to which the COVID-19 pandemic impacts Veracyte’s
businesses, operations, and financial results, including the
duration and magnitude of such effects, will depend on numerous
factors, which are unpredictable, including, but not limited to,
the duration and spread of the outbreak, its severity, the actions
to contain the virus or treat its impact, and how quickly and to
what extent normal economic and operating conditions can resume.
These forward-looking statements speak only as of the date hereof
and, except as required by law, 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.
Veracyte, Afirma, Percepta, Envisia, Prosigna, "Know by Design"
and the Veracyte, Afirma, Percepta, Envisia and Prosigna logos are
registered trademarks of Veracyte in the U.S. and selected
countries.
Paper cited: Johnson, M.K., Wu, S., Pankratz, D.G. et al.
Analytical validation of the Percepta genomic sequencing
classifier; an RNA next generation sequencing assay for the
assessment of Lung Cancer risk of suspicious pulmonary nodules. BMC
Cancer 21, 400 (2021).
https://doi.org/10.1186/s12885-021-08130-x
1 Choi Y, Qu J, Wu S, Hao Y, Zhang J, Ning J, et al. Improving
Lung Cancer risk stratification leveraging whole Transcriptome RNA
sequencing and machine learning across multiple cohorts. BMC Med
Genet. 2020;13(Suppl 10):151.
https://doi.org/10.1186/s12920-020-00782-1 2 World Health
Organization 3 American Lung Association
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version on businesswire.com: https://www.businesswire.com/news/home/20210427005884/en/
Investor and Media Contact: Tracy Morris Vice President
of Corporate Communications & Investor Relations
tracy.morris@veracyte.com 650-380-4413
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