Myriad’s BRACAnalysis CDx® Test Identifies Patients with Ovarian Cancer Who Would Benefit from Second-Line Maintenance Tre...
26 Oktober 2016 - 1:15PM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that its
BRACAnalysis CDx® test accurately identified patients who may
benefit from treatment with olaparib. The BRACAnalysis CDx
test was included in the SOLO2 study (NCT01874353) as a diagnostic
with olaparib, an oral PARP inhibitor being developed by
AstraZeneca (Nasdaq:AZN).
SOLO2 compared maintenance olaparib against placebo in patients
with platinum-sensitive relapsed ovarian cancer. In this
study, patients were tested for germline BRCA (gBRAC+) mutations as
determined by Myriad’s BRACAnalysis CDx test. The primary endpoint
for SOLO2 was progression-free survival (PFS). The aim was to
determine whether patients carrying gBRAC mutations treated with
olaparib as a second-line maintenance therapy experienced longer
progression-free survival, compared to those patients receiving
placebo. The results showed that the olaparib-treated
patients achieved the primary endpoint of prolonged PFS.
“These outstanding findings represent another meaningful
advancement for ovarian cancer patients,” said Johnathan Lancaster,
M.D., Ph.D., gynecologic oncologist and chief medical officer of
Myriad Genetic Laboratories. “Importantly, the results
demonstrated that BRCA status as determined by BRACAnalysis CDx can
identify patients likely to benefit from PARP inhibition
therapy.”
The collaboration between Myriad and AstraZeneca on olaparib
began in 2007. In Dec. 2014, Myriad received FDA approval for
BRACAnalysis CDx to 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
reviewed and 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 ovarian cancer patients with
deleterious or suspected deleterious germline BRCA variants
eligible for treatment with Lynparza™ (olaparib). 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.
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 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 ability of the BRACAnalysis CDx test to
identify patients with ovarian cancer who may benefit from
treatment with olaparib; the importance of the BRACAnalysis
CDx test for this patient population and the ability to identify
patients likely to benefit from PARP inhibition therapy; 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) 285-0248
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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