Myriad Receives FDA Approval of BRACAnalysis CDx® as Companion Diagnostic for Lynparza® (olaparib) In Patients with Germlin...
December 30 2019 - 7:05AM
Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular
diagnostics and precision medicine, today announced that
the U.S. Food and Drug Administration (FDA) has approved
BRACAnalysis CDx® for use as a companion diagnostic test by
healthcare professionals to identify patients with metastatic
pancreatic cancer who have a germline BRCA mutation and are
candidates for treatment with PARP inhibitor
Lynparza
® (olaparib). Lynparza is marketed
by AstraZeneca (LSE/OMX Nordic/NYSE: AZN) and Merck, known as MSD
outside of the U.S. and Canada. BRACAnalysis CDx is the first
and only FDA-approved genetic test for this indication.
“The approval of the BRACAnalysis CDx test for
patients with pancreatic cancer highlights our shared vision and
long-standing collaboration with Myriad to advance precision
medicine for patients in need of new treatments,” said Ruth March,
Ph.D., senior vice president and head of Precision Medicine,
Oncology R&D, AstraZeneca. “Patients with metastatic
pancreatic cancer who test positive for germline-BRCA mutations can
now access Lynparza, which is the first and only PARP
inhibitor approved for this devastating disease.”
Pancreatic cancer is the third most common cause of
cancer-related death in the United States, and germline
BRCA-mutated pancreatic cancer accounts for 6.2 percent of all
cases. In February 2019, the National Comprehensive Cancer
Network (NCCN) updated its oncology guidelines to recommend
universal germline BRCA testing for all people with pancreatic
cancer.
“We congratulate AstraZeneca and Merck on obtaining
FDA approval of Lynparza for people with metastatic pancreatic
cancer, and we are excited to expand the use of BRACAnalysis CDx as
a companion diagnostic test,” said Nicole Lambert, president of
Myriad Oncology. “The new FDA approval and recently updated
NCCN guidelines support physicians who order testing at the time of
diagnosis. The sooner we can identify patients with
germline BRCA mutations, the better chance they will have to
benefit from precision therapies.”
The collaboration between Myriad and AstraZeneca began in 2007
and has resulted in multiple regulatory approvals for BRACAnalysis
CDx enabling more patients to benefit from treatment with
olaparib.
- December 2019: FDA approved BRACAnalysis CDx
as a companion diagnostic to identify patients with pancreatic
cancer who are eligible for treatment with Lynparza.
- February 2019: The Japanese Ministry of
Health, Labour, and Welfare approved BRACAnalysis CDx as a
companion diagnostic to identify women with ovarian cancer who have
a germline BRCA mutation and are eligible for first-line
maintenance therapy with Lynparza.
- December 2018: FDA approved BRACAnalysis CDx
as a companion diagnostic to identify patients newly diagnosed with
advanced ovarian cancer who are eligible for first-line maintenance
treatment with Lynparza.
- March 2018: The Japanese Ministry of Health,
Labour, and Welfare approved BRACAnalysis CDx as a companion
diagnostic to identify patients with
germline BRCAm metastatic breast cancer who have been
previously treated with chemotherapy and are eligible for treatment
with Lynparza.
- January 2018: FDA approved BRACAnalysis CDx as
a companion diagnostic to identify patients with
germline BRCAm metastatic breast cancer who have been
previously treated with chemotherapy and are eligible treatment
with Lynparza.
- August 2017: FDA approved BRACAnalysis CDx as
a complementary diagnostic to identify patients with recurrent
platinum-sensitive germline BRCAm ovarian cancer who are
eligible for maintenance treatment with Lynparza.
- Dec. 2014: FDA approved BRACAnalysis CDx as a
companion diagnostic to identify patients with advanced ovarian
cancer who are eligible for fourth-line treatment with
Lynparza.
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 collected in EDTA.
Single nucleotide variants and small insertions and deletions
(indels) are identified by polymerase chain reaction (PCR) and
Sanger sequencing. Large deletions and duplications in BRCA1
and BRCA2 are detected using multiplex PCR. Results of the
test are used as an aid in identifying cancer patients with
deleterious or suspected deleterious germline BRCA variants, who
are or may become eligible for treatment with
Lynparza® (olaparib). Detection of deleterious or
suspected deleterious germline BRCA1 and BRCA2 variants by the
BRACAnalysis CDx test in ovarian cancer patients is also associated
with enhanced progression-free survival (PFS) from Zejula™
(niraparib) maintenance therapy. This assay is for professional use
only and is to be performed only at Myriad Genetic Laboratories, a
single laboratory site located at 320 Wakara Way, Salt Lake City,
UT 84108. Learn more at www.bracanalysiscdx.com.
Lynparza is a registered trademark of AstraZeneca.
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.
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 patients now having access to Lynparza;
expanding the use of BRACAnalysis CDx as a companion diagnostic
test; 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)
584-3065rogers@myriad.com
Investor Contact: Scott Gleason(801)
584-1143sgleason@myriad.com
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