Myriad Genetics
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
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