Myriad Will Seek Japanese Regulatory Approval for BRACAnalysis CDx®
November 07 2016 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that it will
submit its BRACAnalysis CDx® test for approval by Japan’s
Pharmaceuticals and Medical Devices Agency (PMDA) in parallel
with the PMDA review of AstraZeneca’s novel PARP inhibitor,
olaparib.
BRACAnalysis CDx is the leading genetic test to identify
patients who are likely to benefit from treatment with olaparib,
which is a novel PARP inhibitor that targets tumor DNA repair
pathway deficiencies to preferentially kill cancer cells.
"BRACAnalysis CDx launched precision medicine for ovarian cancer
patients by identifying patients more likely to respond to PARP
inhibitors," said Mark C. Capone, president and CEO, Myriad
Genetics. "As a global leader in personalized medicine,
Myriad is committed to providing the highest quality molecular
tests in the fight against the world's most challenging diseases,
including breast and ovarian cancers."
Today’s announcement builds on a long-term companion diagnostic
collaboration with AstraZeneca that began in 2007. In
December 2014, the U.S. Food and Drug Administration (FDA) approved
BRACAnalysis CDx to identify ovarian cancer patients who may be
appropriate for treatment with Lynparza™ (olaparib). It was
the first time the FDA had approved a laboratory developed test
(LDT) under the premarket approval application process.
About BRACAnalysis CDx®BRACAnalysis CDx is an
in vitro diagnostic device intended for the qualitative detection
and classification of variants in the protein coding regions and
intron/exon boundaries of the BRCA1 and BRCA2 genes using genomic
DNA obtained from whole blood specimens. It is approved for
use as a companion diagnostic with AstraZeneca’s Lynparza
(olaparib) for patients with advanced ovarian cancer in the United
States and Europe.
About OlaparibOlaparib is the first in a class
of drugs that act as inhibitors of poly(ADP)-ribose polymerase
(PARP), which exploit tumor DNA repair pathway deficiencies to
preferentially kill cancer cells. It is marketed in the
United States and Europe under the brand name Lynparza for patients
with advanced ovarian cancer.
About Myriad GeneticsMyriad Genetics Inc., is a
leading personalized medicine company dedicated to being a trusted
advisor transforming patient lives worldwide with pioneering
molecular diagnostics. Myriad discovers and commercializes
molecular diagnostic tests that: determine the risk of developing
disease, accurately diagnose disease, assess the risk of disease
progression, and guide treatment decisions across six major medical
specialties where molecular diagnostics can significantly improve
patient care and lower healthcare costs. Myriad is focused on
three strategic imperatives: transitioning and expanding its
hereditary cancer testing markets, diversifying its product
portfolio through the introduction of new products and increasing
the revenue contribution from international markets. For more
information on how Myriad is making a difference, please visit the
Company's website: www.myriad.com.
Myriad, the Myriad logo, BART, BRACAnalysis, Colaris, Colaris
AP, EndoPredict, myPath, myRisk, Myriad myRisk, myRisk Hereditary
Cancer, myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, Vectra, Prolaris and GeneSight are trademarks or
registered trademarks of Myriad Genetics, Inc. or its wholly owned
subsidiaries in the United States and foreign countries. MYGN-F,
MYGN-G
Note to Editors:Lynparza is a trademark of
AstraZeneca.
Safe Harbor StatementThis press release
contains “forward-looking statements” within the meaning of the
Private Securities Litigation Reform Act of 1995, including
statements relating to submitting the Company’s BRACAnalysis
CDx® test for approval by Japan’s Pharmaceuticals and Medical
Devices Agency (PMDA) in parallel with the PMDA review of
AstraZeneca’s novel PARP inhibitor, olaparib; expanding the
Company’s companion diagnostic collaboration with AstraZeneca; and
the Company’s strategic directives under the caption “About
BRACAnalysis CDx” and “About Myriad Genetics.” 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 described or implied 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 pharmaceutical and clinical services
may decline or will not continue to increase at historical rates;
risks related to our ability to transition from our existing
product portfolio to our new tests; 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; risks related to increased
competition and the development of new competing tests and
services; 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 licenses to the technology
underlying our molecular diagnostic tests and pharmaceutical and
clinical 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, including but not limited to our acquisition of Assurex,
Sividon and the Clinic; 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; the risk that we may be unable to comply with
financial operating covenants under our credit or lending
agreements; the risk that we will be unable to pay, when due,
amounts due under our credit or lending agreements; and other
factors discussed under the heading “Risk Factors” contained in
Item 1A of our Annual report on Form 10-K for the fiscal year ended
June 30, 2016, which has been 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.
Media Contact:
Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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