Myriad Announces Prolaris(R) Test Biopsy Results From EMPATHY-P Study at European Association of Urology Annual Meeting
March 20 2015 - 2:05AM
Prolaris Modifies Risk Assessment for 42 Percent of European
Prostate Cancer Patients
SALT LAKE CITY and ZURICH, Switzerland, March 20,
2015 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today
announced that results from the EMPATHY-P clinical study of
Prolaris in patients newly diagnosed with prostate cancer will be
highlighted at the 30th Annual
Congress of the European Association of Urology.
"EMPATHY-P showed that Prolaris provides valuable
clinical information that can help physicians improve healthcare
and outcomes for their patients with early prostate cancer," said
Colin Hayward, M.D., European medical director, Myriad. "There is
no one-size-fits-all treatment approach in prostate cancer.
Prolaris provides objective genetic information to help clinicians
tailor treatment plans based on patients' individual risk
profiles."
The EMPATHY-P study evaluated the Prolaris test on
525 patient biopsy samples to determine the aggressiveness of
prostate cancer in these newly diagnosed patients from five
European countries including: Italy, Germany, Spain, Switzerland
and the UK. The patients' biopsy samples also were evaluated using
standard clinical pathology methods (D'Amico/AUA risk
stratification), which were then compared to the Prolaris test
results.
The EMPATHY-P data showed, overall, that the
Prolaris test found 42 percent of the European men evaluated had a
risk profile that was either lower or higher than would be expected
using clinical pathology. Interestingly, this finding is
consistent with the previously published U.S. Prostate Biopsy
Research study, which found 51 percent of U.S. patients had a risk
profile that differed from clinical pathology. Specifically,
EMPATHY-P demonstrated that the Prolaris test score found 22
percent of the European patients had less aggressive prostate
cancer and 20 percent had more aggressive prostate cancer compared
to standard clinical pathology measurements.
"Prolaris has been shown in multiple clinical
studies to be more effective than clinical pathology at determining
the aggressiveness of prostate cancer and providing patients with
an accurate risk profile based on their own genetic signature,"
said Hayward. "Our data showed comparable results for both
European and U.S. patients. In both groups, men with a low Prolaris
score are good candidates for active surveillance, while patients
with a high Prolaris score may need more aggressive care."
Poster Presentation Details
at EAU
Title: |
Poster #321 - European multi-centre study to assess the
aggressiveness |
|
of prostate carcinoma in newly diagnosed patients using a
cell-cycle gene |
|
expression assay. (Prolaris) in biopsy specimens
(EMPATHY-P Study). |
Presenter: |
E. Porpiglia. |
Date: |
Poster Session 26 - Sunday, March 22, 2015, 8:45 a.m. to
10:15 a.m. |
Room: |
Room Paris. |
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. For more information visit:
www.prolaris.com.
About Myriad Genetics
GmbH
Myriad Genetics GmbH is based in Zurich,
Switzerland and is the international subsidiary of Myriad Genetics
Inc., 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. For more information on
how Myriad Genetics GmbH is making a difference, please visit the
Company's European website: www.myriadgenetics.eu/.
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 is focused on strategic initiatives to grow
existing markets, diversify through the introduction of new
products, including companion diagnostics, and expand
internationally. For more information on how Myriad is making
a difference, please visit the Company's website:
www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk
Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx,
HRD, Vectra and Prolaris 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 EMPATHY-P
study data with Prolaris® being
featured at the 30th Annual
Congress of the European Association of Urology; the ability of the
Prolaris test to provide valuable clinical information to help
physicians improve care and health outcomes for their patients with
prostate cancer; the ability of the Prolaris test to more
effectively stratify patients based on their risk profile than
clinical pathology; and the Company's strategic directives under
the caption "About Myriad Genetics." These risks and uncertainties
include, but are not limited to: the risk that sales and profit
margins of our molecular diagnostic tests and pharmaceutical and
clinical services may decline or will not continue to increase at
historical rates; risks related to our ability to transition from
our existing to new testing services, including unexpected costs
and delays; risks related to changes in the governmental or private
insurers' reimbursement levels for our tests or our ability to
obtain reimbursement for our new tests at comparable levels to our
existing tests; risks related to increased competition and the
development of new competing tests and services; the risk that we
may be unable to develop or achieve commercial success for
additional molecular diagnostic tests and pharmaceutical and
clinical services in a timely manner, or at all; the risk that we
may not successfully develop new markets for our molecular
diagnostic tests and pharmaceutical and clinical 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 pharmaceutical and clinical
services and any future tests and services 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 our projections about our business,
results of operations and financial condition; risks related to the
potential market opportunity for our products 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 or other intellectual property; risks
related to changes in intellectual property laws covering our
molecular diagnostic tests and pharmaceutical and clinical 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 Annual Report on Form 10-K for the fiscal year ended
June 30, 2014, which has been 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.
CONTACT: Media Contact:
Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
This
announcement is distributed by NASDAQ OMX Corporate Solutions on
behalf of NASDAQ OMX Corporate Solutions clients.
The issuer of this announcement warrants that they are solely
responsible for the content, accuracy and originality of the
information contained therein.
Source: Myriad Genetics, Inc. via Globenewswire
HUG#1904976
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Mar 2024 to Apr 2024
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Apr 2023 to Apr 2024