BRACAnalysis CDx® Approved by U.S. Food and Drug Administration as Companion Diagnostic for AstraZeneca’s Lynparza® (olap...
December 19 2018 - 1:10PM
Myriad Genetics, Inc. (NASDAQ: MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that
the U.S. Food and Drug Administration (FDA) has approved
BRACAnalysis CDx® to be used by healthcare professionals to
identify patients with advanced ovarian cancer who have a germline
BRCA mutation (gBRCAm) and are eligible for first-line maintenance
therapy with AstraZeneca’s PARP (poly ADP ribose polymerase)
inhibitor, Lynparza® (olaparib) following response to
platinum-based chemotherapy.
“We congratulate AstraZeneca and Merck on obtaining FDA approval
of Lynparza for patients with BRCAm advanced ovarian cancer, and we
are excited to expand the use of BRACAnalysis CDx as the companion
diagnostic test in this population,” said Lloyd Sanders, president,
Myriad Oncology. “We estimate there are more than 20,000
patients newly diagnosed with ovarian cancer in the United States
every year who qualify for a BRACAnalysis CDx test.”
The FDA approvals are based on results from the SOLO-1 trial
(ClinicalTrials.gov number: NCT01844986) that tested Lynparza
tablets as a maintenance treatment for patients with,
advanced-stage BRCAm ovarian cancer who experienced a complete or
partial response following first-line standard platinum-based
chemotherapy. The study results were published in the New
England Journal of Medicine, and the key finding was that Lynparza
maintenance therapy cut risk of disease progression or death by 70
percent.
“In the SOLO1 trial, Myriad’s BRACAnalysis CDx test identified
patients with advanced ovarian cancer who may benefit from
Lynparza,” said Johnathan Lancaster, M.D., Ph.D.,
gynecologic-oncologist and chief medical officer, Myriad
Genetics. “The FDA’s approval underscores the need for all
patients with ovarian cancer to know their BRACAnalysis CDx results
at the time of diagnosis so they can fully understand their
treatment options.”
Lynparza is being commercialized by AstraZeneca and Merck &
Co., Inc. (known as MSD outside the US and Canada). The
collaboration between Myriad and AstraZeneca on olaparib began in
2007 and has resulted in multiple regulatory approvals for
BRACAnalysis CDx.
- 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 olaparib.
- March 2018: The Japanese Ministry of Health,
Labour, and Welfare approved BRACAnalysis CDx as a companion
diagnostic to identify patients with metastatic breast cancer who
are eligible for second-line treatment with olaparib.
- January 2018: FDA approved BRACAnalysis CDx as
a companion diagnostic to identify patients with metastatic breast
cancer who are eligible for second-line treatment with
olaparib.
- August 2017: FDA approved BRACAnalysis CDx as
a complementary diagnostic to identify patients with ovarian cancer
who are eligible for second-line treatment with
olaparib.
- 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
olaparib.
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. 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: http://myriadmychoice.com/.
About Myriad Genetics
Myriad 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: build 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 HRD, EndoPredict, Vectra, GeneSight, riskScore Prolaris,
ForeSight and Prelude 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 Statement
This press release contains "forward-looking statements" within
the meaning of the Private Securities Litigation Reform Act of
1995, including statements related to the U.S. Food and Drug
Administration’s approval of BRACAnalysis CDx® to be used by
healthcare professionals to identify patients with advanced-stage,
BRCA-mutated (BRCAm) ovarian cancer who are eligible for treatment
with AstraZeneca’s PARP (poly ADP ribose polymerase) inhibitor,
Lynparza® (olaparib); the indication for Lynparza for first-line
maintenance therapy; the estimated number of women who are
diagnosed with ovarian cancer in the United States who qualify for
a BRACAnalysis CDx test; the Company’s plans to expand the use of
BRACAnalysis CDx as the companion diagnostic test for Lynparza
patients with advanced-stage, BRCA-mutated (BRCAm) ovarian cancer;
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, 2018, 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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