Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular
diagnostics and precision medicine, announced that Japan’s Ministry
of Health, Labour and Welfare (MHLW) has approved the BRACAnalysis®
Diagnostic System (i.e., “BRACAnalysis”) to help physicians
determine which women with breast cancer have Hereditary Breast and
Ovarian Cancer (HBOC) syndrome and qualify for additional medical
management. BRACAnalysis is a genetic test that identifies germline
mutations in the BRCA1/2 genes.
“We are excited that the MHLW has approved the BRACAnalysis
Diagnostic System for HBOC risk assessment in patients with breast
cancer,” said Seigo Nakamura, M.D., Ph.D., Professor and Chairman,
Department of Surgery, Division of Breast Surgical Oncology and
Director, Breast Center of Showa University Hospital in Tokyo and
president of the Japanese Organization of Hereditary Breast and
Ovarian Cancer (JOHBOC). “Our goal is to use the BRACAnalysis test
to identify patients with BRCA mutations and determine who will
benefit from more advanced medical care.”
Under the MHLW decision, physicians may use BRACAnalysis to test
for BRCA mutations in women with breast cancer who meet the genetic
testing guidelines defined by JOHBOC. Those patients who test
positive for a deleterious BRCA mutation will be eligible to
receive advanced medical management, such as prophylactic surgery
or targeted therapies.
“Myriad’s BRACAnalysis test is the gold standard for BRCA
testing. The approval of BRACAnalysis for HBOC risk assessment in
Japan is further validation of the quality and utility of our
pioneering genetic test,” said Gary A. King, executive vice
president of International Operations, Myriad Genetics. “We look
forward to working with our commercial partners in Japan to ensure
that BRACAnalysis is available to patients.”
Myriad has an exclusive partnership with SRL Inc., a subsidiary
of Miraca Group, to commercialize the BRACAnalysis Diagnostic
System in Japan.
Today’s announcement follows two prior regulatory approvals for
the BRACAnalysis Diagnostic System in Japan. In February 2019,
BRACAnalysis was approved as a companion diagnostic for Lynparza®
(olaparib) in women with ovarian cancer, and in March 2018, it was
approved as a companion diagnostic for Lynparza in patients with
metastatic inoperable or recurrent breast cancer.
About the BRACAnalysis®
Diagnostic SystemBRACAnalysis is
a diagnostic system that classifies a patient’s clinically
significant variants (DNA sequence variations) in the germline
BRCA1 and BRCA2 genes. Variants are classified into one of
the five categories; “Deleterious,” “Suspected Deleterious,”
“Variant of Uncertain Significance,” “Favor Polymorphism,” or
“Polymorphism.” Once the classification is completed, the results
are sent to medical personnel in Japan for determining the
eligibility of patients for treatment with Lynparza.
About SRLSince the establishment in 1970, SRL,
Inc., a member of the Miraca Group, Japan-based leading healthcare
group, has been providing comprehensive testing services as the
largest commercial clinical laboratory in Japan. SRL carries
out nearly 400,000,000 tests per year, covering a wide range of
testing services including general/emergency testing,
esoteric/research testing, companion diagnostics tests, genomic
analysis, and etc. For more information, please visit
https://www.srl-group.co.jp/english/.
About Myriad GeneticsMyriad Genetics Inc., is a
leading precision 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 critical success factors: building upon a solid
hereditary cancer foundation, 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 CDx, EndoPredict, Vectra, GeneSight, riskScore, Prolaris,
ForeSight and Prequel 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.
Lynparza is a registered 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 Japan’s Ministry of Health, Labour and
Welfare (MHLW) marketing approval of the company’s BRACAnalysis
Diagnostic System to identify patients with breast cancer who would
be eligible for additional medical management; the Company working
with commercial partners in Japan to ensure that BRACAnalysis is
available to patients; 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 set forth in or implied by forward-looking
statements. These risks and uncertainties include, but are
not limited to: the risk that sales and profit margins of our
molecular diagnostic tests and pharmaceutical and clinical services
may decline; risks related to our ability to transition from our
existing product portfolio to our new tests, including unexpected
costs and delays; risks related to decisions or changes in
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 and any future tests and services are terminated
or cannot be maintained on satisfactory terms; risks related to
delays or other problems with operating our laboratory testing
facilities and our healthcare clinic; risks related to public
concern over 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 our projections about our
business, results of operations and financial condition; risks
related to the potential market opportunity for our products 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 or other
intellectual property; 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 most recent Annual Report on Form 10-K for the
fiscal year ended June 30, 2019, 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. 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.
Media Contact: Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact: Scott
Gleason(801) 584-1143sgleason@myriad.com
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