Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that
the U.S. Food and Drug Administration (FDA) approved
BRACAnalysis CDx® for use as a companion diagnostic by healthcare
professionals to identify patients with HER2-negative metastatic
breast cancer who have a germline BRCA mutation and are candidates
for treatment with the PARP inhibitor Lynparza (olaparib), marketed
by AstraZeneca and Merck, known as MSD outside of the U.S. and
Canada. BRACAnalysis CDx is the first and
only FDA-approved test for use in this indication.
“This important advance underscores the need for patients with
HER2-negative metastatic breast cancer to know their BRCA status
with an FDA approved test to help ensure that they will receive the
best available therapy,” said Johnathan Lancaster, M.D., Ph.D.,
chief medical officer of Myriad Genetics. “As shown in the
OlympiAD study, Myriad’s BRACAnalysis CDx test was proven to
accurately identify those patients who had a germline BRCA mutation
and may benefit from Lynparza.”
The approval also adds to the body of knowledge about the
clinical use and value of companion diagnostics to enable
personalized medicine for people with cancer.
“We congratulate AstraZeneca and Merck on obtaining FDA approval
of Lynparza for patients with metastatic breast cancer, which is
the first approval of a PARP inhibitor outside of ovarian
cancer. As the pioneers in identifying likely responders to
PARP inhibitors, we are excited to broaden the use of BRACAnalysis
CDx as the companion diagnostic for this important new indication,”
said Mark C. Capone, president and CEO, Myriad Genetics. “We
will be actively working with all stakeholders to raise awareness
so that patients can be immediately tested to determine if they are
likely to benefit from Lynparza.”
Approximately one in eight women are diagnosed with breast
cancer in the United States, and one-third are diagnosed with or
will progress to the metastatic stage of the disease.
“There are more than 155,000 patients with metastatic breast
cancer in the United States, and we estimate that 125,000 do not
know their BRCA status,” said Lancaster. “This new FDA
approval of BRACAnalysis CDx for patients with metastatic breast
cancer significantly expands the population who can access BRCA
testing and potentially benefit from PARP inhibition therapy.”
The collaboration with AstraZeneca to develop a novel companion
diagnostic test to identify candidates for treatment with olaparib
began in 2007. The new metastatic breast cancer indication is
the second FDA approval of BRACAnalysis CDx for use in conjunction
with Lynparza. In Dec. 2014, Myriad received FDA approval for
BRACAnalysis CDx to help identify patients with advanced ovarian
cancer who are eligible for fourth-line treatment with
olaparib. BRACAnalysis CDx is Myriad’s first FDA-approved
companion diagnostic and was the first-ever laboratory developed
test approved by the FDA.
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 breast and ovarian 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 BRCA 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: http://myriadmychoice.com/.
About Lynparza Lynparza (olaparib) is an
innovative, first-in-class oral poly ADP-ribose polymerase (PARP)
inhibitor that exploits tumor DNA damage response (DDR) pathway
deficiencies to preferentially kill cancer cells. Lynparza is
the foundation of AstraZeneca’s industry-leading portfolio of
compounds targeting DNA damage response (DDR) mechanisms in cancer
cells. Lynparza is currently approved in the United States for the
maintenance treatment of adult patients with recurrent epithelial
ovarian, fallopian tube or primary peritoneal cancer, who are in a
complete or partial response to platinum-based chemotherapy and for
the treatment of adult patients with deleterious or suspected
deleterious germline BRCA-mutated advanced ovarian cancer who have
been treated with three or more prior lines of chemotherapy.
Patients are selected for therapy based on Myriad’s FDA-approved
companion diagnostic. It is also approved by regulatory health
authorities in the EU for use as monotherapy for the maintenance
treatment of adult patients with platinum-sensitive relapsed
BRCA-mutated (germline and/or somatic) high grade serous epithelial
ovarian, fallopian tube or primary peritoneal cancer who are in
response (complete or partial) to platinum-based chemotherapy.
In July 2017, AstraZeneca and Merck announced a global strategic
oncology collaboration to jointly co-develop and co-commercialize
Lynparza.
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 ability of the Company’s FDA approved
test to help ensure that HER2-negative metastatic breast cancer
patients will receive the best available therapy; the OlympiAD
study and FDA’s approval of BRACAnalysis CDx® for use in
HER2-negative metastatic breast cancer patient broadening the use
of BRACAnalysis CDx® as a companion diagnostic; the Company
actively working with all stakeholders to raise awareness so that
patients can be immediately tested to determine if they are likely
to benefit from Lynparza; one-third of breast cancer patients being
diagnosed with or progressing to the metastatic stage of the
disease; this new FDA approval of BRACAnalysis CDx® for patients
with metastatic breast cancer significantly expanding the
population who can access BRCA testing and potentially benefit from
PARP inhibition therapy; the 155,000 patients with metastatic
breast cancer in the United States, and our estimates that 125,000
do not know their BRCA status, now potentially gaining access; 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: |
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Ron Rogers |
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Investor Contact: |
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Scott Gleason |
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(801) 584-3065 |
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(801) 584-1143 |
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rrogers@myriad.com |
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sgleason@myriad.com |
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