Non-invasive genomic test is designed to help
physicians guide next steps for current and former smokers with
lung nodules
Veracyte, Inc. (Nasdaq: VCYT) announced that clinical validation
data published in the journal CHEST show that the company’s
Percepta Nasal Swab test determines lung cancer risk, with high
accuracy, among people who currently smoke or have previously
smoked and have lung nodules. The findings suggest that the novel,
non-invasive genomic test can help physicians guide next steps for
these patients, enabling them to potentially avoid unnecessary
invasive procedures or accelerate time to appropriate
treatment.
Lung cancer is the leading cause of cancer death worldwide. Lung
nodules are an early indicator of lung cancer and are typically
found using computed tomography (CT) scans. In the United States,
approximately 15 million people are eligible for annual lung cancer
screening with low-dose CT scans based on their smoking history and
other factors and currently an estimated 1.6 million lung nodules
are found incidentally each year in patients being evaluated with a
CT scan for an unrelated condition. While most lung nodules are not
cancerous, their detection can result in unnecessary diagnostic
procedures and anxiety for patients. At the same time, early
detection of cancerous nodules can lead to better patient
outcomes.
“Physicians need an objective, accurate tool to help guide care
for patients when a lung nodule is found on a CT scan,” said Bill
Bulman, M.D., Veracyte’s medical director for Pulmonology and an
author on the CHEST manuscript. “Our findings reinforce the ability
of the Percepta Nasal Swab test to improve risk assessment of lung
nodules and help avoid unnecessary diagnostic procedures for those
at low risk of cancer while supporting timely diagnosis and
treatment for those with high risk of cancer.”
Veracyte’s Percepta Nasal Swab test is a simple, non-invasive
genomic test that can be done in the physician’s office and is
designed to assess lung cancer risk in patients who currently smoke
or have previously smoked and have lung nodules found on CT scans.
The test reports whether a patient has a high-, moderate- or
low-risk for lung cancer, providing insights to help physicians
objectively determine which patients with lung nodules to work up
for lung cancer and which patients to simply monitor with
imaging.
For the CHEST study, researchers used the Percepta Nasal Swab
test, which was trained on a cohort of 1,120 patients with lung
nodules that were either malignant or benign, to evaluate nasal
samples from an independent cohort of 312 eligible patients
followed for at least 12 months or until a final diagnosis of
benign or malignant was determined.
Results show that the Percepta Nasal Swab test is highly
accurate in identifying patients with low-risk nodules (97%
sensitivity, with 40% specificity). This high sensitivity provides
a negative predictive value, or NPV, of 98% in a population with a
25% cancer prevalence, meaning the test could assist physicians in
avoiding unnecessary invasive procedures in patients with a benign
nodule, with a very small risk of missing a cancer.
Similarly, researchers found that the test is highly accurate in
identifying patients with high-risk nodules (92% specificity, with
57% sensitivity). This high specificity provides a positive
predictive value, or PPV, of 70% in a population with a 25% cancer
prevalence, meaning the test could assist physicians in directing
these patients to further procedures so they could obtain an
accurate diagnosis and speed time to treatment, if necessary.
The Percepta Nasal Swab test had consistently high performance
across various groups of patients within the study cohort,
including those with prior cancers and different lung cancer
subtypes, lung nodule sizes (including nodules <8 mm), smoking
histories and lung cancer screening eligibility, suggesting the
test’s potential clinical value in a wide range of patients. In
contrast, currently available physician risk calculators were
developed with specific patient populations in mind and tend to
perform unevenly across different types of patients.
“We believe our Percepta Nasal Swab test can be
paradigm-changing in the evaluation of lung cancer risk among
patients with lung nodules,” said Dr. Bulman. “By helping to guide
next steps for physicians and their patients, we aim to help make
lung nodule evaluation, including through lung cancer screening
programs, more efficient and effective.”
Publication of the Percepta Nasal Swab test clinical validation
study is an important step in Veracyte’s journey toward securing
payer reimbursement for the test, prior to the test being made
widely available. Additionally, the company is currently conducting
a prospective clinical utility study, known as NIGHTINGALE, at
hospitals and clinics around the United States to demonstrate the
test’s ability to improve patient care and outcomes.
The Percepta Nasal Swab test was developed with RNA
whole-transcriptome sequencing and machine-learning technology. It
utilizes foundational "field of injury" science, which evaluates
genomic changes associated with lung cancer that can be found in
epithelial cells in the nasal passages of current and former
smokers.
About Veracyte
Veracyte (Nasdaq: VCYT) is a global diagnostics company whose
vision is to transform cancer care for patients all over the world.
We empower clinicians with the high-value insights they need to
guide and assure patients at pivotal moments in the race to
diagnose and treat cancer. Our high-performing tests enable
clinicians to make more confident diagnostic, prognostic, and
treatment decisions for some of the most challenging diseases such
as thyroid, prostate, breast, bladder and lung cancers, as well as
interstitial lung diseases. We help patients avoid unnecessary
procedures and speed time to diagnosis and appropriate treatment.
In addition to making our tests available in the U.S. through our
central laboratories, we also aim to deliver our tests to patients
worldwide through a distributed model to laboratories that can
perform them locally. 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 our clinical tests in and outside of the United
States. Forward-looking statements can be identified by words such
as: “appears,” "anticipate," "intend," "plan," "expect," "believe,"
"should," "may," "will," “positioned,” “designed” and similar
references to future periods. Examples of forward-looking
statements include, among others, that the Percepta Nasal Swab test
can help physicians guide next steps for patients who currently
smoke or have previously smoked and have lung nodules, enabling
them to potentially avoid unnecessary invasive procedures or
accelerate time to appropriate treatment; the Percepta Nasal Swab
Test can potentially help those who are low risk avoid unnecessary
diagnostic procedures, including surgery, while supporting timely
treatment for those who have the disease; and the Percepta Nasal
Swab test may help make lung nodule evaluation more efficient and
effective. 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 on February 22, 2023, and our
Quarterly Report on Form 10-Q filed for the three months ended
September 30, 2023. Copies of these documents, when available, may
be found in the Investors section of our website at
https://investor.veracyte.com. These forward-looking statements
speak only as of the date hereof and, except as required by law, we
specifically disclaim 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, the Veracyte logo and Percepta are registered
trademarks of Veracyte, Inc. and its subsidiaries in the U.S. and
selected countries.
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version on businesswire.com: https://www.businesswire.com/news/home/20231129259153/en/
Investors: Shayla Gorman Director, Investor Relations
investors@veracyte.com 619-393-1545
Media: Tracy Morris Vice President of Global Corporate
Communications tracy.morris@veracyte.com 650-380-4413
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