Myriad Obtains CE Mark for Tumor BRACAnalysis CDx(TM) and Launches Test in Europe as Companion Diagnostic for PARP Inhibitors
January 08 2015 - 12:05AM
Identifies Up to 44 Percent More Eligible Patients Than
Conventional BRCA Tests
SALT LAKE CITY and ZURICH, Jan. 8, 2015 (GLOBE
NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) today announced
the Company has obtained CE Marking in Europe for its Tumor
BRACAnalysis CDx test, which identifies tumors that have mutations
in the BRCA1 or BRCA2
genes. Tumor BRACAnalysis CDx is the first and only tumor-based
companion diagnostic that is CE-marked and can identify patients
that would be appropriate for Lynparza, a poly ADP-ribose
polymerase (PARP) inhibitor.
"Obtaining a CE Marking for Tumor BRACAnalysis CDx
is a significant milestone and achievement for the Myriad team.
The CE Mark allows us to offer a validated tumor-based test
for use as a companion diagnostic with Lynparza and future PARP
inhibitors in Europe," said Gary King, executive vice president,
International Operations, Myriad. "We are actively engaged in
strategic activities with thought leaders and cancer centers to
ensure a successful launch in Europe."
Last month, the European Medicines Agency's (EMA)
approved Lynparza as monotherapy for maintenance treatment of adult
patients with platinum-sensitive relapsed BRCA-mutated (germline
and/or somatic) high grade serous epithelial ovarian, fallopian
tube, or primary peritoneal cancer who are in complete or partial
response to platinum-based chemotherapy. It is estimated that
more than 28 percent of ovarian cancer patients carry a deleterious
germline or somatic mutation in the BRCA1 or
BRCA2 genes and may benefit from Lynparza
therapy. In clinical studies conducted by Myriad, the Tumor
BRACAnalysis CDx test identified up to 44 percent more cancer
patients with BRCA mutations who are
candidates for treatment with PARP inhibitors, compared to
conventional germline BRCA testing alone.
"The trend in modern medicine is toward tailored
therapy that will give patients the best chance for successful
outcomes. In ovarian cancer, it is critical to identify which
patients have somatic or germline BRCA
mutations and may benefit from the new class of PARP inhibitors,"
said Colin Hayward, M.D., European medical director,
Myriad. "Tumor BRACAnalysis CDx is the most effective method
for screening patients since it detects both germline and somatic
BRCA mutations. It provides physicians
with confidence that they will identify the greatest number of
patients who are candidates for this new breakthrough class of
drugs."
Myriad Genetics GmbH offers Tumor BRACAnalysis CDx
throughout Europe performed at its laboratories in Munich,
Germany. The test has an average 14-day laboratory turnaround
time, which is essential for timely treatment decision-making by
physicians and patients For more information, please call
Myriad Genetics GmbH at: +41 44 939 91 44 or visit:
http://www.myriadgenetics.eu.
About Tumor BRACAnalysis
CDx(TM)
Myriad's Tumor BRACAnalysis CDx is the most robust
and accurate companion diagnostic test for identifying both
germline (hereditary) and somatic (tumor) cancer-causing mutations
in the BRCA1 and BRCA2
genes. Tumor BRACAnalysis CDx has undergone significant
analytic validation and has been shown to identify up to 44 percent
more patients with cancer-causing BRCA1/BRCA2
mutations compared to germline testing alone. Myriad is
actively collaborating with leading pharmaceutical companies to
develop Tumor BRACAnalysis CDx as a companion diagnostic for use
with certain PARP inhibitors, platinum-based drugs and other novel
chemotherapeutic agents.
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 directives to grow our markets,
introduce new products, including companion diagnostics, as well as
to expand internationally. For more information on how Myriad is
making a difference, please visit the Company's websites:
www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris AP, myPath, myRisk, myRisk
Hereditary Cancer, myChoice, myPlan Lung Cancer, BRACAnalysis CDx,
Tumor 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
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.
Notes to
Editors
*Lynparza is a trademark of AstraZeneca
PLC.
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
launch of Tumor BRACAnalysis CDx in Europe; offering Tumor
BRACAnalysis CDx as a validated tumor-based test for use as a
companion diagnostic with Lynparza and future PARP inhibitors in
Europe; Tumor BRACAnalysis CDx being the most effective
method for screening patients by detecting both germline and
somatic BRCA mutations; providing the Tumor BRACAnalysis CDx test
at the Company's laboratory facilities in Munich, Germany; and the
Company's statements under the captions "About Tumor BRACAnalysis
CDx," "About Myriad Genetics" and "About Myriad Genetics
GmbH." These "forward-looking statements" are based on
management's current 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 set forth in
or implied by forward-looking statements. These risks and
uncertainties include, but are not limited to: the risk that sales
and profit margins of our existing molecular diagnostic tests and
pharmaceutical and clinical 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 or our ability to obtain reimbursement for our new tests
at comparable levels to our existing tests; 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 we may not be successful in transitioning from our existing
product portfolio to our new products, such as our myRisk
Hereditary Cancer test, which represents the next generation of our
existing hereditary cancer franchise; the risk that we may not be
able to generate sufficient revenue from our existing tests and our
new tests or develop new tests; the risk that licenses to the
technology underlying our molecular diagnostic tests and
pharmaceutical and clinical services and any future tests are
terminated or cannot be maintained on satisfactory terms; risks
related to delays or other problems with manufacturing our products
or operating our laboratory testing facilities; risks related to
public concern over 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; risks related to our projections about the potential
market opportunity for our products; 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 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 in 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
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#1885207
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