Myriad Announces Prolaris(R) Test Biopsy Results From EMPATHY-P Study at European Association of Urology Annual Meeting
(Thomson Reuters ONE) -
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 30(th) 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
Poster #321 - European multi-centre study to assess the
Title: 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.
Poster Session 26 - Sunday, March 22, 2015, 8:45 a.m. to 10:15
Date: 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
30(th) 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(at)myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason(at)myriad.com
This announcement is distributed by GlobeNewswire on behalf of
GlobeNewswire clients. The owner of this announcement warrants that:
(i) the releases contained herein are protected by copyright and
other applicable laws; and
(ii) they are solely responsible for the content, accuracy and
originality of the information contained therein.
Source: Myriad Genetics, Inc. via GlobeNewswire
[HUG#1904976]
Unternehmensinformation / Kurzprofil:
Datum: 20.03.2015 - 07:05 Uhr
Sprache: Deutsch
News-ID 379956
Anzahl Zeichen: 10702
contact information:
Town:
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Kategorie:
Business News
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"Myriad Announces Prolaris(R) Test Biopsy Results From EMPATHY-P Study at European Association of Urology Annual Meeting"
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