Myriad Genetics Submits Premarket Approval to FDA for BRACAnalysis(R)
April 07 2014 - 4:30PM
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® 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
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