Veracyte, Inc. (Nasdaq: VCYT), a leading cancer diagnostics
company, today announced that a new study published in JCO
Precision Oncology shows that, among patients undergoing Active
Surveillance (AS) for prostate cancer, the Decipher Prostate
Genomic Classifier is prognostic for identifying those whose
disease is likely to progress. The findings make the Decipher test
the only gene expression test to have treatment-outcome data from a
prospective, multi-center, phase 2, randomized trial in the AS
population.
Patients whose prostate cancer is found at an early stage and
who are clinically low or intermediate risk are commonly offered
AS, meaning they are closely monitored rather than undergo
intervention such as surgery or radiation. Identifying the optimal
candidates for active surveillance, however, is not always easy, as
clinical indicators are limited in their ability to identify those
who may be at a higher risk of future grade reclassification or
cancer progression.
“The findings from the ENACT trial analysis demonstrate that the
Decipher Prostate test is a predictor of disease progression on
AS,” said Elai Davicioni, Ph.D., Veracyte’s medical director for
Urology. “These data also further reinforce Veracyte’s commitment
to evidence generation that supports the Decipher Prostate test’s
‘Level 1B’ evidence status – the highest among commercially
available gene expression tests – in the most recent NCCN®
Guidelines* for prostate cancer.”
The new findings are from the biomarker analysis study of the
ENACT clinical trial (NCT02799745) that aimed to compare the
efficacy and safety of enzalutamide monotherapy plus AS vs AS alone
in patients with low-risk or intermediate-risk prostate cancer. The
study included 121 AS patients from the randomized trial who were
monitored and followed for 3 years. In the AS alone or control arm,
among patients with available tumor samples (n=65), the Decipher
Prostate test predicted increased rates of disease progression
after adjusting for baseline clinical risk factors (MVA HR [95% CI]
per 10% increase in score: 1.17 [1.01 to 1.35]; P = 0.04).
The findings also demonstrated the use of Decipher GRID (Genomic
Resource for Intelligent Discovery) as a research tool to help
advance scientific understanding of prostate cancer. Specifically,
the researchers evaluated whole-transcriptome data derived from
Decipher Prostate testing of each sample in the study to assess the
Decipher Prostate test and other, research-based biomarkers that
could potentially indicate which tumors would be more likely to
respond to treatment with enzalutamide, an androgen receptor (AR)
signaling inhibitor. They observed that the subset of patients with
higher Decipher scores, as well as luminal and high AR activity
subtypes, had greater responses to enzalutamide.
“Our Decipher GRID tool enables researchers to analyze
whole-transcriptome data for prostate cancer samples to gain
further insights about the disease, which can ultimately further
improve patient care,” said Dr. Davicioni. “This study is a strong
example of the Veracyte Diagnostics Platform in action, whereby we
use a comprehensive, whole-transcriptome approach to develop a
test, which fuels our ability to demonstrate the test’s performance
and utility, and also enables new discovery efforts.”
About the Decipher Prostate Genomic Classifier
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 75 studies involving more than 100,000 patients.
About the 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.
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 NCCN Guidelines’ impact on physicians’ better use of the
Decipher prostate test and to our expectations that the Decipher
Prostate test helps physicians better personalize their patients’
care in recommending less intensive versus more intensive treatment
options. Forward-looking statements can be identified by words such
as: “appears,” “anticipate,” “intend,” “plan,” “expect,” “believe,”
“should,” “may,” “will,” “enable,” “positioned,” “offers,”
“designed” 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 March 1, 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. 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.
* National Comprehensive Cancer Network. NCCN makes no
warranties of any kind whatsoever regarding their content, use or
application and disclaims any responsibility for their application
or use in any way.
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Investors: Shayla Gorman investors@veracyte.com
619-393-1545
Media: Tracy Morris media@veracyte.com 650-380-4413
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