Veracyte, Inc. (Nasdaq: VCYT) announced that new data presented
today at the 24th Annual Meeting of the Society of Urologic
Oncology (SUO 2023) highlight clinical observations and
translational research conducted by users of the company’s Decipher
Prostate Genomic Classifier. These independent, real-world studies
provide further evidence supporting the clinical utility of the
test in the treatment and management of prostate cancer,
particularly for patients considering active surveillance.
Not all types of prostate cancer require immediate intervention;
many can be monitored carefully over time with active surveillance,
while more aggressive cancers have better outcomes with treatment.
Identifying the appropriate candidates for active surveillance,
however, is not always easy, as the clinical indicators used to
assess patient risk often do not reliably distinguish between
favorable and more aggressive disease.
Researchers at the Washington University School of Medicine in
St. Louis presented two posters at the SUO meeting based on
separate analyses of their Decipher biopsy cohort of 888 patients
with prostate cancer who were seen at their institution between
December 2016 and March 2023. In the first study, the researchers
analyzed 235 patients who were initially managed with active
surveillance, among whom 88 patients ultimately progressed to
receive treatment. In evaluating clinical information available
prior to treatment, including PSA levels, Gleason score, and
results from magnetic resonance imaging (MRI), along with Decipher
Prostate Genomic Classifier results, they found that the Decipher
Prostate Genomic Classifier score was the only predictor of
progression from active surveillance to treatment.
The second study focused on 104 patients who had a
multiparametric MRI (mpMRI) result, Gleason Grade Groups 1-3 on
biopsy, and Decipher testing prior to treatment with radical
prostatectomy (surgery to remove the prostate). The researchers
compared all of the available information prior to treatment to
determine the best predictor of final pathology after
prostatectomy. While multiparametric MRI (mpMRI) is often viewed as
prognostic of cancer pathology, this study found that Decipher
scores were strongly associated with final pathology, but clinical
variables such as PSA levels, Gleason score and mpMRI were not.
While mpMRI is often viewed as prognostic of cancer pathology, this
study found that only Decipher scores were strongly associated with
final pathology, while clinical variables such as PSA levels,
Gleason score and mpMRI results were not.
“Accurately predicting disease progression in patients with
prostate cancer is essential so they can receive the treatment that
is best suited for them,” said Eric Kim, M.D., associate professor
of surgery at Washington University School of Medicine in St. Louis
and senior author of both posters. “Our studies consistently
demonstrated that data from the Decipher Prostate Genomic
Classifier was more reliably predictive of prostate cancer
progression and underlying pathology than any other clinical data
available, including MRI.”
Two other studies came from researchers at the University of
Miami who used the ongoing Miami MAST prospective trial (MRI
selection for active surveillance versus treatment; NCT02242773) to
better understand cancer progression at the molecular level. In one
study, researchers characterized 224 samples from 124 patients
based on cancer progression. Assessment with the Decipher Prostate
Genomic Classifier and biological insights from the Decipher
Genomic Resource for Intelligent Discovery (GRID) research tool
indicated that Decipher scoring was associated with grade
progression, but not volume progression, of prostate cancer.
Finally, a large-scale, population-based study of over 52,000
patients tested with the Decipher Prostate biopsy test, led by
investigators from the University of Michigan, found wide variation
in Decipher risk distribution within and across clinical stage
groups, suggesting that genomic assessment identified something
that the clinical information does not. From this population-based
initiative they concluded that integration of the test into
clinical care can provide more precise prognosis estimates for
patients and lead to better individualized risk assessment.
“We developed the Decipher Prostate Genomic Classifier to
provide actionable information that helps guide patient care,” said
Elai Davicioni, Ph.D., Veracyte’s medical director for Urology.
“The data presented at SUO 2023 show how users of our test,
conducting prospective research on their own patients, affirm the
utility of Decipher in real-world settings. This real-world
evidence and scientific research conducted by Decipher users shows
how physicians can refine their surveillance or treatment plans
based on a more comprehensive view of each patient’s cancer. We are
very grateful for the work conducted by these clinician-scientists
on behalf of the entire prostate cancer research community.”
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 integration of the Decipher
Prostate Genomic Classifier into clinical care can provide more
precise prognosis estimates for patients and lead to better
individualized risk assessment; the Decipher Prostate Genomic
Classifier can provide actionable information that helps guide
patient care; and the Decipher Prostate Genomic Classifier can help
physicians refine their surveillance or treatment plans based on a
more comprehensive view of each patient’s cancer. 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 March 1, 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.
Decipher Prostate is available in the U.S. as part of Veracyte’s
CLIA-validated laboratory developed test (LDT) service. This test
has not been cleared or approved by the FDA. Veracyte, the Veracyte
logo, and Decipher 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/20231201811059/en/
Investors: Shayla Gorman Sr. Director, Investor Relations
investors@veracyte.com 619-393-1545
Media: Tracy Morris VP of Global Corporate Communications
tracy.morris@veracyte.com 650-380-4413
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