DGAP-News: Myriad Genetics, Inc. /
Myriad Genetics Submits Premarket Approval to FDA for BRACAnalysis(R)
07.04.2014 / 22:30
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BRACAnalysis to be Used as Companion Diagnostic for AstraZeneca's Olaparib
SALT LAKE CITY, 2014-04-07 22:30 CEST (GLOBE NEWSWIRE) --
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that it has submitted the
first module of a premarket approval (PMA) application to the Food and Drug
Administration (FDA) for the use of BRACAnalysis(r) testing as a companion
diagnostic with olaparib. Olaparib is an investigational, orally active
poly-ADP ribose polymerase (PARP) inhibitor being developed by AstraZeneca.
'We believe an FDA-approved BRACAnalysis test will provide additional assurance
that patients are receiving the most accurate test results and improve patient
care by identifying candidates for treatment with olaparib,' said Mark Capone,
president of Myriad Genetics Laboratories. 'Our PMA application for
BRACAnalysis will provide the FDA with scientific data to evaluate the safety
and effectiveness of BRACAnalysis as a companion diagnostic.'
Consistent with the FDA's modular premarket approval process, Myriad submitted
the first of four PMA modules and is working to submit the remaining modules
according to a pre-specified plan. The modular approach allows FDA to review
each module as it is received and provides Myriad with timely feedback from FDA
in order to help resolve issues early in the review process.
'Our PMA submission is a milestone for Myriad and BRACAnalysis is one of the
first laboratory developed tests submitted for FDA premarket approval,' said
Capone. 'Our ability to navigate the regulatory process is benefitted by our
extensive experience in testing 1.2 million patients and our commitment to high
quality.'
The collaboration between Myriad and AstraZeneca on olaparib began in 2007.
Since then, the two companies have shared scientific insight and worked closely
together to move cancer research forward. In 2012, Myriad made strides in
developing BRACAnalysis as a companion diagnostic by retrospectively genotyping
patients in a previously completed Phase 2 study of olaparib. This is a
powerful example of how a companion diagnostic can advance the goals of
personalized medicine by stratifying patients in a clinical trial.
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
website: www.myriad.com.
Myriad, the Myriad logo and Prolaris, Myriad myPath, Myriad myPlan, Myriad
myRisk, 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 an FDA-approved BRACAnalysis test providing additional assurance
that patients are receiving the most accurate test results and improving
patient care by identifying candidates for treatment with olaparib; the
Company's PMA application for BRACAnalysis providing the FDA with scientific
data to evaluate the safety and effectiveness of BRACAnalysis as a companion
diagnostic; and the Company's strategic directives under the caption 'About
Myriad Genetics.' These 'forward-looking statements' are management's present
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 described in the forward-looking statements. These risks
include, but are not limited to: the risk that sales and profit margins of our
existing molecular diagnostic tests and companion diagnostic 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; the risk that we may be unable to develop or achieve commercial success
for additional molecular diagnostic tests and companion diagnostic services in
a timely manner, or at all; the risk that we may not successfully develop new
markets for our molecular diagnostic tests and companion diagnostic 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 companion diagnostic services tests and any future tests
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 increased competition and the
development of new competing tests 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; risks related to changes
in intellectual property laws covering our molecular diagnostic tests and
companion diagnostic 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 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
News Source: NASDAQ OMX
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Language: English
Company: Myriad Genetics, Inc.
United States
ISIN: US62855J1043
End of News DGAP News-Service
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262057 07.04.2014
DGAP-News: Myriad Genetics Submits Premarket Approval to FDA for BRACAnalysis(R)
| Source: EQS Group AG