Myriad Announces Prolaris(R) Test Biopsy Results From EMPATHY-P Study at European Association of Urology Annual Meeting
March 20 2015 - 2:05AM
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
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