BRACAnalysis® CDx Identifies Patients Who Respond to Lynparza® in SOLO-1 Study
June 28 2018 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a worldwide leader in
personalized medicine, today announced that the Company’s
BRACAnalysis® CDx test identified responders to Lynparza®,
AstraZeneca and Merck’s (known as MSD outside the US and Canada)
PARP inhibitor, in the Phase III, SOLO-1 study. The study
evaluated patients with advanced ovarian cancer treated in the
first line setting, and who tested positive with Myriad’s
BRACAnalysis CDx test for a germline BRCA mutation. In the
study, those patients who received Lynparza maintenance therapy had
a statistically-significant and clinically-meaningful
improvement in progression-free survival compared to placebo.“This
is the first study to show that a PARP inhibitor can lead to
improved patient outcomes in first line ovarian cancer,” said Mark
C. Capone, president and CEO of Myriad Genetics. “We look
forward to partnering with both AstraZeneca and Merck to ensure
patients have the broadest possible access to this important
therapy option.”Myriad Genetics plans to work with AstraZeneca and
Merck along with regulatory authorities to ensure BRACAnalysis CDx
is available to women with ovarian cancer in the first line
maintenance setting as quickly as possible.
About BRACAnalysis® CDxBRACAnalysis 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 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: 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 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.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 a PARP inhibitor leading to improved patient
outcomes in first line ovarian cancer, the Company partnering with
both AstraZeneca and Merck to ensure patients have the broadest
possible access to this important therapy option, the Company
working with AstraZeneca and Merck along with regulatory
authorities to ensure BRACAnalysis CDx is available to women with
ovarian cancer in the 1st-line maintenance setting as quickly as
possible, 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, 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.
Media Contact: Ron Rogers
(801)
584-3065
rrogers@myriad.com
Investor Contact: Scott Gleason(801)
584-1143sgleason@myriad.com
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Aug 2024 to Sep 2024
Myriad Genetics (NASDAQ:MYGN)
Historical Stock Chart
From Sep 2023 to Sep 2024