Myriad’s BRACAnalysis CDx® Test Effectively Identified Metastatic Breast Cancer Patients with Improved Outcomes from Pfize...
December 12 2017 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that data
from the EMBRACA trial showed Myriad’s BRACAnalysis CDx® test
successfully identified patients with metastatic breast cancer
(MBC) who responded to Pfizer’s investigational PARP inhibitor,
talazoparib.
The EMBRACA trial (NCT01945775) data were presented last
week at the 2017 San Antonio Breast Cancer Symposium (SABCS).
The study included approximately 400 patients, all of whom tested
positive for germline BRCA mutations as determined by Myriad’s
FDA-approved BRACAnalysis CDx test. As presented at SABCS,
the results demonstrated that patients with gBRCA+ locally advanced
and/or MBC demonstrated superior progression-free survival (PFS) in
patients treated with talazoparib, compared to patients who
received physician’s choice standard-of-care chemotherapy.
Additionally, the PFS benefit was consistent across metastatic
BRCA-positive patients, including those with hormone
receptor-positive and triple negative disease.
“BRACAnalysis CDx is the only germline companion diagnostic test
approved by the FDA to identify patients with BRCA1/2 mutations,
and we are excited to support Pfizer’s clinical development program
and help identify patients who are most likely to benefit from
talazoparib,” said Mark C. Capone, president and CEO, Myriad
Genetics. “As the pioneers in companion diagnostics for PARP
inhibitors, we are excited that more patients may benefit from
these novel drugs in the future.”
It is estimated there are approximately 60,000 patients with
metastatic breast cancer, two thirds of whom are not currently
eligible for BRCA testing based upon family and personal history
alone or current testing criteria.
Myriad first announced its collaboration to develop a novel
companion diagnostic test for talazoparib on Oct. 1, 2013.
Under that agreement (originally with BioMarin; now Pfizer), Myriad
plans to submit a supplementary premarket approval (sPMA)
application to the U.S. Food and Drug Administration (FDA) under
its existing PMA for BRACAnalysis CDx to include
talazoparib.
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 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 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
three strategic imperatives: transitioning and expanding its
hereditary cancer testing markets, diversifying its product
portfolio through the introduction of new products and increasing
the revenue contribution from international markets. 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, Vectra, Prolaris, EndoPredict and GeneSight 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
related to the Company supporting Pfizer’s clinical development
program; BRACAnalysis CDx helping identify patients who are most
likely to benefit from talazoparib; the possibility that more
patients may benefit from PARP inhibitor drugs in the future;
estimates of approximately 60,000 patients with metastatic breast
cancer, two thirds of whom are not currently eligible for BRCA
testing based upon family and personal history alone or current
testing criteria; the Company’s plans to submit a supplementary
premarket approval application to the U.S. Food and Drug
Administration under its existing PMA for BRACAnalysis CDx to
include talazoparib; ; and the Company's strategic directives under
the captions “About BRACAnalysis CDx,” and "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; 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, 2016, 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(908)
285-0248rrogers@myriad.com
Investor Contact:Scott Gleason(801)
584-1143sgleason@myriad.com
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