Myriad Establishes Tumor BRACAnalysis CDx(TM) Laboratory in Europe
(Thomson Reuters ONE) -
Tumor BRACAnalysis CDx Will Identify More Patients for Treatment With PARP
Inhibitors
SALT LAKE CITY and ZURICH, Oct. 24, 2014 (GLOBE NEWSWIRE) -- Myriad Genetics,
Inc. (Nasdaq:MYGN) today announced it has established a Tumor BRACAnalysis CDx
laboratory in Europe. Myriad's next-generation Tumor BRACAnalysis CDx test is a
companion diagnostic that will identify up to 50 percent more patients with BRAC
mutations who may benefit from treatment with PARP inhibitors, such as olaparib,
compared to conventional germline testing alone.
Olaparib is a novel PARP inhibitor being developed by AstraZeneca. Earlier
today, the European Medicines Agency's (EMA) Committee for Medicinal Products
for Human Use (CHMP) recommended marketing authorization for olaparib as
monotherapy for the 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
response (complete or partial) to platinum-based chemotherapy. It is estimated
that more than 22 percent of all ovarian cancer patients carry a deleterious
germline or somatic mutation in the BRCA1 or BRCA2 genes and may benefit from
olaparib therapy.
"BRCA mutation screening is critical in ovarian cancer patients to identify the
subset of women who might benefit from PARP inhibitors," said Colin Hayward,
M.D., European Medical Director at Myriad. "Tumor BRACAnalysis CDx testing is
the best method for screening ovarian cancer patients because it detects both
germline and somatic mutations, significantly increasing the total number of
patients who may benefit from this life-saving drug."
More than eight years ago, Myriad pioneered the development of germline BRCA
testing as a companion diagnostic for use with PARP inhibitors and other agents.
The new Tumor BRACAnalysis CDx test will expand the reach of this important new
therapeutic class to many more ovarian cancer patients. Tumor BRACAnalysis CDx
will be widely available throughout all of Europe and testing will be conducted
in the Company's laboratories in Munich, Germany. Key features of the Tumor
BRACAnalysis CDx test are:
* Up to 50 percent additional BRCA-deficient tumors detected to more
accurately identify patients who are candidates for therapy with olaparib;
* Expected 3 percent variant of uncertain significance (VUS) rate for
BRCA1/BRCA2 mutations, ensuring a clearer management pathway for ovarian
cancer patients;
* An average 14-day laboratory turnaround time, allowing physicians and
patients to make critical treatment decisions.
Last month at the European Society for Medical Oncology (ESMO) annual meeting in
Madrid, Spain, Myriad presented a study analyzing approximately 130 previously
untreated, high-grade ovarian cancer patients for germline BRCA mutations in
blood samples and somatic mutations in tissue samples. In the study, the
researchers also tested patients undergoing surgery for both of these types of
mutations. Of 92 patients who were tested for both germline and somatic markers,
nearly 20 percent of patients were found to have germline mutations through a
blood test. Meanwhile, testing with the Tumor BRACAnalysis CDx test identified
all 20 percent of patients with germline mutations and an additional eight
percent of patients with a somatic BRCA1/BRCA2 mutation, representing a 44
percent increase in the number of mutations identified.
"Several clinical studies have shown that the Tumor BRACAnalysis CDx test
outperformed germline testing alone in terms of identifying more patients who
are candidates for treatment with PARP inhibitors," said Hayward. "We believe
these results combined with the positive CHMP recommendations for olaparib will
open doors to a new era of personalized medicine for patients with platinum-
sensitive ovarian cancer by helping target PARP therapy to the right patients."
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 50 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
chemotherapeutic agents. In the United States, the testing will be done at the
Company's laboratory in Salt Lake City. In Europe, the test will be performed at
the Company's laboratory in Munich.
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's molecular diagnostic tests are based on an understanding of the role
genes play in human disease and were developed with a commitment to improving an
individual's decision making process for monitoring and treating disease. Myriad
is focused on strategic directives to introduce new products, including
companion diagnostics, as well as expanding 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, 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.
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 the Tumor BRACAnalysis CDx test in Europe; the
Company's belief that the Tumor BRACAnalysis CDx test will identify up to 50
percent more patients who may benefit from treatment with olaparib compared to
conventional germline testing alone; the estimate that 22 percent of all ovarian
cancer patients carry a deleterious germline or somatic mutation in the BRCA1 or
BRCA2 genes which would predict responsiveness to olaparib therapy; BRCA
mutation screening testing being critical in ovarian cancer patients to identify
the subset of women who might benefit from olaparib; Tumor BRACAnalysis CDx
testing being the best method for screening ovarian cancer patients because it
detects both germline and somatic mutations, significantly increasing the total
number of patients who may benefit from this life-saving drug; the Tumor
BRACAnalysis CDx test expanding the reach of this important new therapeutic
class to many more ovarian cancer patients; the availability of the Tumor
BRACAnalysis CDx test throughout all of Europe and testing being conducted in
the Company's laboratory in Munich, Germany; the listed key features of the
Tumor BRACAnalysis CDx test; the Company's belief that these results combined
with the positive CHMP recommendations for olaparib will open doors to a new era
of personalized medicine for patients with platinum-sensitive ovarian cancer by
helping target PARP therapy to the right patients; and the Company's strategic
directives 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(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#1865660]
Unternehmensinformation / Kurzprofil:
Datum: 24.10.2014 - 15:26 Uhr
Sprache: Deutsch
News-ID 346800
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contact information:
Town:
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Kategorie:
Business News
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