Veracyte, Inc. (Nasdaq: VCYT) today announced new data
suggesting its novel genomic tests may positively impact diagnosis
and care for patients being evaluated for interstitial lung disease
(ILD) or lung cancer. The findings were presented at ATS 2023, the
annual meeting of the American Thoracic Society, which is being
held May 21-24 in Washington, D.C.
Findings from two posters suggest that the Envisia Genomic
Classifier helps improve diagnosis and changes treatment decisions
for patients with ILD. In an independent, real-world, multi-center
study, researchers evaluated data for 98 patients with ILD for whom
traditional high-resolution computed tomography (HRCT) and clinical
factors alone failed to provide a clear diagnosis of ILD type. The
Envisia test identified 42 patients with usual interstitial
pneumonia (UIP), a lung-scarring pattern that is a hallmark of
idiopathic pulmonary fibrosis (IPF), one of the most serious types
of ILD. UIP is also associated with progressive disease that is not
IPF. The test also identified 56 patients without UIP.
An Envisia-positive result for UIP prompted an increase in use
of anti-fibrotic drugs (from 11.9% to 71.4%), which are used to
treat IPF and other progressive ILDs. An Envisia-positive result
for UIP also led to a reduction in immuno-suppressant drugs (from
23.8% to 9.5%), which can be harmful to patients with IPF.
“IPF and other progressive forms of ILD are often challenging to
diagnose using traditional methods. Yet, accurate diagnosis is key
to ensuring that patients receive timely and appropriate
treatment,” said Fayez Kheir, M.D., a pulmonologist at
Massachusetts General Hospital in Boston and an author of the
study. “Our findings suggest that use of the Envisia test helped
physicians arrive at a more precise diagnosis and begin treatment
with appropriate therapy sooner.”
Findings from the second Envisia study suggest the genomic test
can help identify whether the final diagnosis is IPF or another
progressive fibrotic disease. In the study of 135 patients with
undiagnosed ILD, researchers found that those with an
Envisia-positive result for UIP had a lower baseline lung function,
as measured by median forced vital capacity (FVC) testing results,
compared to patients with an Envisia-negative result for UIP (64%
vs. 75%). Patients with Envisia-positive results also had a greater
absolute decline over one year (3% decline vs. 1% increase,
p=0.03). The Envisia-positive group also had similar absolute
declines in FVC over one year, regardless of whether they were
diagnosed with IPF or another type of ILD (2.5% vs. 3%).
"These findings suggest that the Genomic Classifier may help
identify patients who may progress and potentially prompt treatment
interventions to decrease rate of progression,” said Ganesh Raghu,
M.D., director of the Center for Interstitial Lung Diseases at the
University of Washington Medical Center.
For Veracyte’s Percepta Nasal Swab, researchers presented
updated preliminary study findings showing the test’s potential to
better stratify the risk of lung cancer for patients with lung
nodules. The novel test is designed to help physicians more
accurately, quickly and confidently assess cancer risk in lung
nodules found on CT scans. Armed with this and other information,
physicians may recommend that the nodule simply be monitored with
imaging or may direct the patient to more-invasive diagnostic
procedures or treatment.
The data continued to show that the Percepta Nasal Swab may
classify more lung nodule patients as either low-risk or high-risk
for lung cancer, as compared to the standard-of-care approach,
which consists of a physician’s own assessment of clinical factors
or use of risk calculators, along with CT imaging. This additional
clarity could potentially help more patients with benign nodules
avoid unnecessary procedures, while ensuring that those patients at
higher risk of cancer receive a diagnosis and treatment more
quickly.
Previous data have demonstrated that the Percepta Nasal Swab
test is highly accurate when it identifies patients as low-risk or
high-risk for lung cancer. The test is available to a limited
number of institutions as part of NIGHTINGALE, a multi-center,
prospective trial that is underway to demonstrate its clinical
utility.
“The data presented at ATS 2023 underscore Veracyte’s commitment
to delivering novel tests that help physicians make better
diagnosis and treatment decisions for their patients being
evaluated for serious lung diseases,” said Bill Bulman, M.D.,
Veracyte’s medical director, Pulmonology. “Importantly, these
findings suggest that our tests in interstitial lung disease and
lung cancer are performing as intended.”
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. An example of forward-looking
statements include, among others, that use of the Envisia test can
help physicians arrive at a more precise diagnosis and begin
treatment with appropriate therapy sooner; the Genomic Classifier
may help identify patients who may progress and potentially prompt
treatment interventions to decrease rate of progression; and
Percepta Nasal Swab may classify more lung nodule patients as
either low-risk or high-risk for lung cancer, as compared to the
standard-of-care approach. 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 March 30, 2023. Copies of these documents, when
available, may be found in the Investors section of our website at
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, Envisia and Percepta are registered
trademarks of Veracyte, Inc. and its subsidiaries in the U.S. and
selected countries.
Veracyte delivers Envisia Genomic Classifier and Percepta Nasal
Swab from its CLIA laboratories. Those tests are not CE-IVD marked
and have not been cleared or approved by the FDA; their performance
characteristics were determined by Veracyte. Please contact
Veracyte for confirmation.
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version on businesswire.com: https://www.businesswire.com/news/home/20230524005250/en/
Investors: Shayla Gorman Director, Investor Relations
investors@veracyte.com 619-393-1545 Media: Tracy Morris Vice
President, Global Corporate Communications
tracy.morris@veracyte.com 650-380-4413
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