Myriad Genetics to Present Three Clinical Studies on Prolaris(R) at the 2014 American Urological Association Annual Meeting
May 01 2014 - 7:05AM
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced clinical data
from three studies on Prolaris in prostate cancer patients will be
featured at the 2014 American Urological Association (AUA) Annual
Meeting, being held May 16–21, 2014, in Orlando, Fla. Prolaris is a
novel molecular diagnostic test that accurately predicts
cancer-specific death and metastases in men with prostate cancer
and is a stronger indicator of clinical outcomes than Gleason score
or PSA. In clinical practice, Prolaris is the only test to
demonstrate that physicians changed their treatment plans in 65
percent of cases after receiving the test report – 40 percent of
patients had a reduction in therapeutic burden, while 25 percent
had an increase in therapeutic burden.
At the AUA annual meeting, new data will be presented from the
largest clinical validation study to date of any gene-based
prognostic test in patients with prostate cancer diagnosed from
biopsy. In the second study to be presented, the data will show
that the Prolaris test significantly outperformed the current
procedure of upgrading to Gleason 3+4 or 4+3 in predicting
biochemical recurrence after a radical prostatectomy. The third
study will show the prognostic utility of Prolaris based on needle
biopsy samples. These studies add to the growing body of outcomes
data for Prolaris, which has been extensively validated in 11
clinical studies and more than 5,000 patients. Myriad also will
present new data from an investigational diagnostic test for
patients with renal cell carcinoma.
"More than ever, we are committed to developing novel molecular
diagnostic tests to help to improve patient outcomes, survival and
quality of life for people living with prostate and renal cancers,"
said Michael Brawer, M.D., vice president of Medical Affairs at
Myriad. "Our Prolaris test is rapidly becoming the leading test to
help the 240,000 men diagnosed with prostate cancer each year to
determine if they have aggressive prostate cancer or not. We're
also actively developing a new prognostic test for renal cell
cancer, which affects 60,000 people every year."
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2014
AUA – POSTER PRESENTATIONS |
|
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Title: |
Validation of a 46-gene cell cycle
progression (CCP) RNA signature for predicting prostate cancer
death in a conservatively managed watchful waiting needle biopsy
cohort. |
Presenter: |
Jack Cuzick |
Date: |
Tuesday, May 20, 3:30 p.m. to 5:30 p.m.
EDT |
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Title: |
Cell Cycle Progression (CCP) outperforms
upgrading to Gleason 3+4 or 4+3 in predicting biochemical
recurrence after prostatectomy. |
Presenter: |
Matthew Cooperberg |
Date: |
Tuesday, May 20, 3:30 p.m. to 5:30 p.m.
EDT |
|
|
Title: |
Prognostic utility of the cell cycle
progression (CCP) score generated from needle biopsy in men treated
with prostatectomy. |
Presenter: |
Jay Bishoff |
Date: |
Tuesday, May 20, 3:30 p.m. to 5:30 p.m.
EDT |
|
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Title: |
Cell cycle progression score predicts
metastatic progression of clear cell renal cell carcinoma after
resection. |
Presenter: |
James Brown |
Date: |
Sunday, May 18, 1:00 p.m. to 3:00 p.m.
EDT |
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 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 5,000 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
are terminated or cannot be maintained on satisfactory terms; risks
related to delays or other problems with operating our laboratory
testing facilities; risks related to public concern over our
genetic testing in general or our tests in particular; risks
related to regulatory requirements or enforcement in the United
States and foreign countries and changes in the structure of the
healthcare system or healthcare payment systems; risks related to
our ability to obtain new corporate collaborations or licenses and
acquire new technologies or businesses on satisfactory terms, if at
all; risks related to our ability to successfully integrate and
derive benefits from any technologies or businesses that we license
or acquire; risks related to increased competition and the
development of new competing tests and services; the risk that we
or our licensors may be unable to protect or that third parties
will infringe the proprietary technologies underlying our tests;
the risk of patent-infringement claims or challenges to the
validity of our patents; risks related to changes in intellectual
property laws covering our molecular diagnostic tests and companion
diagnostic services and patents or enforcement in the United States
and foreign countries, such as the Supreme Court decision in the
lawsuit brought against us by the Association for Molecular
Pathology et al; risks of new, changing and competitive
technologies and regulations in the United States and
internationally; and other factors discussed under the heading
"Risk Factors" contained in Item 1A of our most recent Annual
Report on Form 10-K filed with the Securities and Exchange
Commission, as well as any updates to those risk factors filed from
time to time in our Quarterly Reports on Form 10-Q or Current
Reports on Form 8-K. All information in this press release is as of
the date of the release, and Myriad undertakes no duty to update
this information unless required by law.
CONTACT: Media Contact: Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact: Scott Gleason
(801) 584-1143
sgleason@myriad.com
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