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
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™
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
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