Clinical utility study findings based on
analysis of the National Cancer Institute’s SEER database
Veracyte, Inc. (Nasdaq: VCYT) announced the publication of a
large, real-world study reinforcing the Decipher Prostate Genomic
Classifier’s ability to guide personalized treatment approaches for
men with prostate cancer. The study utilized data from the first
linkage of prostate cancer cases reported by central cancer
registries participating in the Surveillance, Epidemiology, and End
Results (SEER) Program, with Decipher test results. SEER is a
population-based cancer registry supported by the National Cancer
Institute (NCI). The findings appear online in JNCI Cancer
Spectrum.
In the U.S., an estimated 288,300 men are expected to be
diagnosed with prostate cancer in 2023 and 34,700 men are expected
to die from the disease.[1] Treatment for prostate cancer is
primarily selected based on clinical risk factors such as Gleason
score, clinical stage and prostate-specific antigen (PSA). Clinical
factors alone, however, do not always reflect the true biology of
the tumor, which can lead to over- or under-treatment of patients
with prostate cancer. The Decipher Prostate test molecularly
assesses the likelihood of a patient’s cancer metastasizing within
the next five years. Armed with this information, a physician can
recommend tailored treatment plans, including no treatment, less
intensive treatment or earlier, more intensive interventions.
"Validation from multiple randomized trials has consistently
demonstrated the prognostic performance of the Decipher 22-gene
expression test,” said Daniel Spratt, M.D., chair of the Department
of Radiation Oncology at UH Cleveland Medical Center. “This study
builds upon this with real-world data of how the test is being used
in a population sample and demonstrates how we are moving toward
the goal of personalized therapy. Patients with a low Decipher
score, indicating a better prognosis, can be guided towards
treatment de-escalation, and those with higher Decipher scores,
indicating a worse prognosis, can be guided towards appropriate
treatment.”
The study analyzed data from 8,297 patients in the SEER registry
who received a primary prostate cancer diagnosis from 2010 to 2018
and underwent Decipher Prostate testing. Researchers evaluated the
association between the patients’ Decipher scores (range 0-1) and
risk groups (low, intermediate and high), and the use of active
surveillance and watchful waiting (AS/WW) as well as adverse
pathology at the time of radical prostatectomy (RP).
The results demonstrated that AS/WW was highest among subjects
with low-risk Decipher biopsy results (41%), compared to those who
had intermediate-risk (27%) or high-risk (11%) scores. Among
subjects with clinically low-risk prostate cancer, 65% of those
with low-risk Decipher results were managed with AS/WW. Among
patients classified as NCCN low or favorable intermediate risk,
higher Decipher risk was associated with greater use of local
therapy and nearly three times the odds of harboring adverse
pathology compared to those with low Decipher risk. The use of
prostatectomy and radiotherapy increased with higher Decipher risk
groups. For example, prostatectomy was used in 22% of low-, 30% of
intermediate-, and 39% of high-risk Decipher patients and
radiotherapy was used in 16% of low-, 24% of intermediate-, and 35%
of high-risk Decipher patients. The study also found a significant
association between higher Decipher risks groups and the use of
post-operative radiotherapy.
"This study is further evidence that the Decipher Prostate test
provides valuable clinical information to physicians and their
patients with prostate cancer. In contemporary practice, physicians
treat patients with higher-risk Decipher scores more aggressively,
and patients with lower-risk Decipher scores more conservatively,”
said Elai Davicioni, Ph.D., Veracyte’s medical director for
Urology. “This is the first large national database study in
ongoing collaborations with the National Cancer Institute SEER
program and represents our sustained commitment to research and
real-world evidence development.”
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. Veracyte is based in South San Francisco,
California. 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 Decipher Prostate
Genomic Classifier’s can guide personalized treatment approaches
for men with prostate cancer; the Decipher Prostate test can assess
the likelihood of a patient’s cancer metastasizing within the next
five years which may assist a physician to recommend tailored
treatment plans, including no treatment, less intensive treatment
or earlier, more intensive interventions; and that patients with a
low Decipher score indicate a better prognosis, can be guided
towards treatment de-escalation, and those with higher Decipher
scores, indicating a worse prognosis, can be guided towards
appropriate treatment. 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 31, 2023. Copies of these documents, when
available, may be found in the Investors section of our website at
. 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.
Veracyte delivers the Decipher Prostate Genomic Classifier 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 and they might be
considered for Research Use Only in some markets. Please contact
Veracyte for confirmation.
- American Cancer Society. Cancer Facts & Figures 2023.
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version on businesswire.com: https://www.businesswire.com/news/home/20230801227697/en/
Investors: Shayla Gorman Director, Investor Relations
investors@veracyte.com 619-393-1545
Media: Michele Parisi mparisi@forwardhealthinc.com
925-864-5028
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