Prolaris(R) Test Predicts Mortality Risk in Prostate Cancer Biopsy Study
May 20 2014 - 07:05AM
Myriad Genetics, Inc. (Nasdaq:MYGN) today presented new data from a
clinical validation study of Prolaris at the 2014 American
Urological Association (AUA) Annual Meeting in Orlando, Fla.
The study is the largest validation study to date of any
gene-based prognostic test in patients with prostate cancer who
were diagnosed by needle biopsy. A key finding was that the
Prolaris test accurately differentiated newly diagnosed patients
who were likely to die from prostate cancer within 10 years from
those with lower-risk disease, which should open the door to more
appropriate clinical care for patients at all risk
levels. Prolaris is a novel molecular diagnostic test that
accurately predicts cancer-specific death and metastases in men
with prostate cancer and is a much stronger indicator of clinical
outcomes than Gleason score or PSA.
"The aggressiveness of newly diagnosed prostate cancer is
variable and difficult to predict. What clinicians really need
is a well-validated prognostic test that accurately predicts
disease-specific mortality and can improve patient care," said Jack
Cuzick, PhD., study investigator and head of the Centre for Cancer
Prevention at Queen Mary University of London. "Currently, with
standard clinical tools like Gleason Score or PSA, we can't
adequately define prognosis. The Prolaris test provides useful
new information and is highly prognostic for disease-specific death
among men being conservatively treated."
In this study, the goal was to validate the Prolaris test score
in 761 conservatively managed prostate cancer patients diagnosed by
needle biopsy. The primary endpoint was prostate cancer death
and the median follow-up time was 9.5 years. The results
showed that for each one unit increase in the Prolaris score,
patients had approximately double the risk of dying from prostate
cancer (see table).
|
Prolaris Predicts
10-Year Death Rates from Prostate Cancer |
Prolaris Test
Score |
<0 |
0-1 |
1.1-2 |
>2 |
Death Rate (%) |
7 |
15 |
36 |
59 |
Data from this study also showed that the Prolaris test is more
predictive of mortality than Gleason score, PSA, age, clinical
stage or extent of disease individually and almost doubles the
total predictive information when they are combined. This study
provides additional significant independent validation of the
prognostic value of the Prolaris score in conservatively managed
patients. The Prolaris test has now been validated in nine
cohorts and more than 6,000 patients.
Prolaris Outperforms Upgrading Practice
In the second study featured at AUA, 230 men who had pathologic
Gleason Scores of either 3+4 or 4+3 were examined. The Prolaris
test was performed on the samples and the rates of biochemical
recurrence (BCR) were compared in each group. The results
showed that there was no difference in BCR based on an assessment
using Gleason Score alone. However, the Prolaris test
significantly outperformed the current practice of upgrading to
Gleason 3+4 or 4+3 in predicting which patients would experience
biochemical recurrence after a radical prostatectomy. These
results underscore that genomic tests must be correlated with
meaningful oncologic endpoints, rather than endpoints like
upgrading. This finding should lead to improved initial
decisions on the most effective treatment for each patient based on
his personal risk of disease progression.
"Prolaris has been extensively validated in thousands of
patients and is the most studied molecular prognostic test for
prostate cancer in history," said Michael Brawer, M.D., vice
president of Medical Affairs at Myriad Genetics. "Prolaris is
rapidly becoming the leading test to assess the aggressiveness of
prostate cancer and to help physicians select the most appropriate
clinical management for patients newly diagnosed with prostate
cancer."
Prolaris Is Strongest Predictor of Metastatic Prostate
Cancer
The third study presented at AUA evaluated the prognostic
utility of the Prolaris score generated from needle biopsy in men
treated with prostatectomy. Importantly, the results of this
study found that the Prolaris test was the strongest predictor of
metastatic disease compared to other tested clinical
variables. Patients with a high Prolaris score have more than
a six-fold higher risk of developing metastases compared to
patients with a low score. These results confirm that Prolaris
may be used at the time of disease diagnosis to better determine
which patients are at highest risk and help select appropriate
medical care based on their personal risk profiles.
About Prostate Cancer
According to the Centers for Disease Control and Prevention
(CDC), prostate cancer is one of the most common cancers among men
and is a leading cause of cancer death. Approximately 240,000
cases of prostate cancer are diagnosed and nearly 30,000 men die
from the disease annually in the United States.
About Prolaris®
Prolaris is a novel 46-gene RNA-expression test that directly
measures tumor cell growth characteristics for stratifying the risk
of disease progression in prostate cancer patients. Prolaris
provides a quantitative measure of the RNA expression levels of
genes involved in the progression of tumor growth. Low gene
expression is associated with a low risk of disease progression in
men who may be candidates for active surveillance and high gene
expression is associated with a higher risk of disease progression
in patients who may benefit from additional therapy. Prolaris has
been proven to predict prostate cancer-specific disease progression
in 11 clinical trials with more than 6,000 patients. For more
information visit: www.prolaris.com.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company
dedicated to making a difference in patients' lives through the
discovery and commercialization of transformative tests to assess a
person's risk of developing disease, guide treatment decisions and
assess risk of disease progression and recurrence. Myriad's
molecular diagnostic tests are based on an understanding of the
role genes play in human disease and were developed with a
commitment to improving an individual's decision making process for
monitoring and treating disease. Myriad is focused on strategic
directives to introduce new products, including companion
diagnostics, as well as expanding internationally. For more
information on how Myriad is making a difference, please visit the
Company's website: www.myriad.com.
Myriad, the Myriad logo, Prolaris, Myriad myPath, Myriad myPlan
and Myriad myRisk are trademarks or registered trademarks of Myriad
Genetics, Inc. in the United States and foreign countries. MYGN-F,
MYGN-G.
Safe Harbor Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements relating to the presentation of Prolaris
clinical study data at the 2014 AUA Annual
Meeting; data showing that physicians would change
their treatment plan of patients with prostate cancer based on
Prolaris test results; the effectiveness of Prolaris testing to
accurately predict cancer-specific disease progression and
mortality when combined with clinical parameters such as Gleason
score and PSA; and the Company's strategic directives under the
caption "About Myriad Genetics." These "forward-looking
statements" are management's present expectations of future events
and are subject to a number of risks and uncertainties that could
cause actual results to differ materially and adversely from those
described in the forward-looking statements. These risks
include, but are not limited to: the risk that sales and profit
margins of our existing molecular diagnostic tests and companion
diagnostic services may decline or will not continue to increase at
historical rates; risks related to changes in the governmental or
private insurers reimbursement levels for our tests; the risk that
we may be unable to develop or achieve commercial success for
additional molecular diagnostic tests and companion diagnostic
services in a timely manner, or at all; the risk that we may not
successfully develop new markets for our molecular diagnostic tests
and companion diagnostic services, including our ability to
successfully generate revenue outside the United States; the risk
that licenses to the technology underlying our molecular diagnostic
tests and companion diagnostic services tests and any future tests
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CONTACT: Media Contact: Ron Rogers
(801) 584-3065
(908) 285-0248
rrogers@myriad.com
Investor Contact: Scott Gleason
(801) 584-1143
sgleason@myriad.com
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