Myriad Submits BRACAnalysis® CDx Application for Regulatory Approval in Japan for HER2- Metastatic Breast Cancer
October 24 2017 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, announced today that it has
submitted BRACAnalysis
® CDx in Japan for review by
the Pharmaceutical Medical Devices Agency (PMDA) and marketing
approval by Ministry of Health, Labor and Welfare as a companion
diagnostic to olaparib for use in HER2- metastatic breast cancer
patients.
“This regulatory submission as a companion diagnostic for a PARP
inhibitor outside the United States reflects another important
major milestone as Myriad seeks to become a global leader in
personalized medicine,” said Mark C. Capone, president and chief
executive officer, Myriad Genetics. “We believe there is broad
applicability across all healthcare systems for our suite of
companion diagnostics tests to improve the quality of care and
lower healthcare costs.”
Myriad estimates there are greater than 10,000 cases of HER2-
metastatic breast cancer per year in Japan which would be eligible
for testing with BRACAnalysis CDx. Myriad will support testing in
the Japanese market through its United States FDA approved
laboratory.
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
five strategic imperatives: Stabilizing hereditary cancer
revenue, growing new product volume, expanding reimbursement
coverage for new products, increasing RNA kit revenue
internationally and improving profitability with Elevate
2020. 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, myPath, myRisk, Myriad myRisk, myRisk Hereditary Cancer,
myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, EndoPredict, Vectra, GeneSight, riskScore and
Prolaris 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.
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 the Company’s submission, timing and
approval of its BRACAnalysis® CDx test in Japan
for review by the Pharmaceutical Medical Devices Agency (PMDA) and
marketing approval by Ministry of Health, Labor and Welfare as a
companion diagnostic to olaparib for use in HER2- metastatic breast
cancer patients; the Company’s belief that there is broad
applicability across all healthcare systems for the Company’s suite
of companion diagnostic tests to improve the quality of care and
lower healthcare costs; the Company’s estimates that there are
greater than 10,000 cases of HER2- metastatic breast cancer per
year in Japan which would be eligible for testing with BRACAnalysis
CDx; the Company’s plans to support testing in the Japanese market
through its United States FDA approved laboratory; and the
Company’s strategic directives under the caption “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, 2017, 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)
584-1143sgleason@myriad.com
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Sep 2023 to Sep 2024