14 Studies Presented at AUA 2024 Show Decipher Tests’ Ability to Help Personalize Care for Prostate and Bladder Cancer Patients and Advance Disease Understanding
May 06 2024 - 4:05PM
Business Wire
Large number of abstracts also showcases power
of the Veracyte Diagnostics Platform
Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics
company, today announced that data from 14 presentations at AUA
2024, the annual meeting of the American Urological Association,
show that the Decipher Prostate and Decipher Bladder Genomic
Classifiers provide better prognostic information for patients with
prostate and bladder cancer, compared to standard approaches. They
also show that the research-use-only Decipher GRID (Genomic
Resource for Intelligent Discovery) tool is helping to advance
scientific understanding of these diseases. The findings were
presented during the conference taking place May 3-6 in San
Antonio.
“The large amount of data presented at AUA 2024 reinforces
Veracyte’s commitment to building rigorous evidence that
demonstrates our tests’ performance and clinical utility,” said
Elai Davicioni, Ph.D., Veracyte’s medical director for Urology.
“Further, our whole-transcriptome approach to testing provides an
incredible amount of data that we are pleased to share with the
research community through Decipher GRID to help advance
understanding of urologic cancers and ultimately improve patient
outcomes.”
Studies showing the Decipher Prostate test’s ability to better
inform prostate cancer treatment include:
- Poster MP41-09: Genomic Signatures Associated with
Adverse Pathologic Features at Radical Prostatectomy Among Active
Surveillance Eligible Men. Presented by Eric Li, M.D., Northwestern
University. Summary: The Decipher Prostate Genomic Classifier
is associated with adverse pathology in patients eligible for
Active Surveillance (AS) who were treated with radical
prostatectomy (RP). The findings suggest the Decipher test may be
able to identify patients at increased risk of harboring higher
grade and non-organ confined disease who may not be ideal
candidates for AS. “Despite having similar clinical features at
diagnosis, our study suggests that AS-eligible prostate cancer
patients have a spectrum of risk for occult adverse pathology that
can be elucidated at the level of gene expression," said Ashley
Ross, M.D., Ph.D., clinical director for the Polsky Urological
Oncology Center at Northwestern University and principal
investigator on the study. “Our results suggest that use of the
Decipher Prostate test may help clinicians better stratify risk
among patients eligible for AS, which may ultimately help reduce
under- and over-treatment.”
- Poster MP41-14: High Decipher scores define the
subgroup most at risk of metastatic progression among patients with
lower-grade tumors classified as NCCN high-risk based on elevated
prostate-specific antigen level alone. Presented by David Han,
M.D., Columbia University Irving Medical Center. Summary:
Despite harboring favorable, lower grade (Grade Group 1 or 2)
organ-confined disease, patients with a prostate-specific antigen
(PSA) level of >20 ng/mL are currently classified by practice
guidelines as “high risk”. In a cohort of 453 patients with
long-term outcomes, the Decipher Prostate test score better
predicted the development of distant metastases than PSA. These
results provide further evidence that a higher Decipher score is a
more accurate risk factor than PSA in patients with otherwise
favorable disease.
- Poster MP49-09: Decipher Predicts Clinically
Significant Upgrading on Final Radical Prostatectomy Pathology.
Presented by John Sheng, M.D., Washington University School of
Medicine in St. Louis. Summary: A large registry (n=760) from
prospective clinical use of Decipher Prostate and multiparametric
prostate MRI (mpMRI) at diagnosis was examined to determine factors
significantly associated with high-grade disease at radical
prostatectomy (RP). In the subset with low- or intermediate-grade
prostate cancer at initial biopsy only Decipher and grade group,
but not mpMRI PIRADS or baseline PSA, predicted high-risk disease
at final pathology after RP.
- Podium Presentation PD42-03: Understanding
Population-Wide Genomic Risk Distribution and Integrating
Clinical-Genomic Risk for Prognostication in Prostate Cancer.
Presented by Udit Singhal, M.D., University of Michigan.
Summary: The International Staging Collaboration for Prostate
Cancer (STAR-CAP) is a highly validated prognostic clinical risk
staging system. In an analysis of 52,565 patients from the
state-wide Michigan Urological Surgery Improvement Collaborative
(MUSIC) and the nation-wide Decipher GRID database, researchers
found wide variation of Decipher Prostate Genomic Classifier scores
within STAR-CAP risk groups. Overall, they found Decipher testing
augmented by at least one STAR-CAP stage both upstaging for about
25% and down-staging for nearly 50% of cases, suggesting that
integration of genomic with advanced clinicopathologic staging
systems may lead to further improvements to risk stratification
across the clinical spectrum of localized disease.
The following study demonstrates the Decipher Bladder test’s
utility in informing treatment decisions for patients with bladder
cancer:
- Poster MP15-07: Molecular subtyping for predicting
non-organ confined disease and survival outcomes after radical
cystectomy in clinical high-grade T1 and T2 bladder cancer
patients. Presented by Yair Lotan, M.D., UT Southwestern Medical
Center. Summary: Clinical staging in bladder cancer commonly
underestimates the true disease stage as many patients are upstaged
to non-organ confined (NOC) disease (pT3+ and/or N+) at radical
cystectomy (RC). This multi-center study of 200 patients validates
prior findings, further demonstrating the utility of the Decipher
Bladder Genomic Subtyping Classifier (GSC) for predicting upstaging
and outcomes in a cohort of patients with clinical T1 or T2 bladder
cancer treated with radical cystectomy but without neoadjuvant
therapy.
Additional studies used the RUO Decipher GRID tool to explore
prostate and bladder cancer topics that include: which patients are
likely to benefit from specific therapies, racial differences in
disease biology, and molecular pathway alterations following
treatment.
“The depth and breadth of Decipher-focused data at AUA 2024
underscores the value of our novel Veracyte Diagnostics Platform,
which begins with delivering high-performing tests using a
comprehensive, whole-transcriptome approach. This fosters
additional research, which in turn supports further innovation to
help more patients,” said Phillip Febbo, M.D., Veracyte’s chief
scientific officer and chief medical officer.
About Decipher Prostate
The Decipher Prostate Genomic Classifier is a 22-gene test,
developed using RNA whole-transcriptome analysis and machine
learning, that helps inform treatment decisions for patients with
prostate cancer. The test is performed on biopsy or surgically
resected samples and provides an accurate risk of developing
metastasis with standard treatment. Armed with this information,
the physician can better personalize their patients’ care and may
recommend less-intensive options for those at lower risk or
earlier, more-intensive treatment for those at higher risk of
metastasis. The Decipher Prostate test has been validated in more
than 80 published studies involving more than 100,000 patients.
More information about the Decipher Prostate test can be found
here.
About Decipher Bladder
The Decipher Bladder Genomic Classifier is a 219-gene test,
developed using RNA whole-transcriptome analysis and machine
learning, that is designed for use in patients following bladder
cancer diagnosis who face questions regarding treatment intensity.
The test classifies bladder tumors into five molecular subtypes,
each having distinct tumor biology and potential clinical
implications. This information can help physicians and their
patients better understand the degree of benefit that would likely
be gained from neoadjuvant chemotherapy and/or the likelihood of
harboring non-organ-confined disease at time of surgery,
respectively. More information about the Decipher Bladder test can
be found here.
About Decipher GRID
The Decipher GRID database includes more than 200,000
whole-transcriptome profiles from patients with urologic cancers
and is used by Veracyte and its partners to contribute to continued
research and help advance understanding of prostate and other
urologic cancers. GRID-derived information is available on a
Research Use Only basis. More information about Decipher GRID can
be found here.
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 Veracyte Diagnostics Platform
delivers high-performing cancer tests that are fueled by broad
genomic and clinical data, deep bioinformatic and AI capabilities,
and a powerful evidence-generation engine, which ultimately drives
durable reimbursement and guideline inclusion for our tests, along
with new insights to support continued innovation and pipeline
development. For more information, please visit www.veracyte.com
and follow the company on X (formerly Twitter) at @veracyte.
Cautionary Note Regarding Forward-Looking Statements
This press release contains forward-looking statements,
including, but not limited to our statements related to the
potential: (i) for the Decipher Prostate and Decipher Bladder
Genomic Classifiers to provide better prognostic information for
patients with prostate and bladder cancer, compared to standard
approaches; (ii) for the Decipher GRID research use only tool to
contribute to further scientific developments and ultimately
patient outcomes; and (iii) for the Veracyte Diagnostics Platform
value to support further innovation and help patients.
Forward-looking statements can be identified by words such as:
“appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,”
“should,” “may,” “will,” “enable,” “positioned,” “offers,”
“designed,” "ultimately," and similar references to future periods.
Actual results may differ materially from those projected or
suggested in any forward-looking statements. 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 potential impact Decipher GRID can have on
scientific advancements in prostate cancer and, in turn, patients.
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 29, 2024. 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 Decipher are registered
trademarks of Veracyte, Inc., and its subsidiaries in the U.S. and
selected countries.
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Investors: Shayla Gorman investors@veracyte.com
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Media: Tracy Morris media@veracyte.com 650-380-4413
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