Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced that four
poster presentations will be featured at the 2016 European Society
for Medical Oncology (ESMO) annual meeting, October 7-11, 2016 in
Copenhagen, Denmark.
“Myriad is a pioneer in personalized medicine and is committed
to improving the prevention, detection and treatment of cancer,”
said Jerry Lanchbury, Ph.D., chief scientific officer,
Myriad Genetics. “We are excited to present these new studies
at ESMO that highlight and advance the science of our
next-generation companion diagnostics to help inform and improve
the treatment of cancer patients.”
Please visit the Myriad booth #408 at ESMO for more
information. Abstracts are available online at:
http://www.esmo.org/Conferences/ESMO-2016-Congress/Abstracts.
Follow Myriad on Twitter via @MyriadGenetics to stay informed about
news and updates from the Company.
Poster
PresentationsTitle: Outcomes of
clinical testing for tumor BRCA1 and BRCA2 gene analysis for 354
patients: First experience with tumor companion diagnostic for PARP
inhibitors.Presenter: Karen Copeland,
M.S.Date: Saturday, Oct. 8, 2016. 1:00-2:00
p.m.Location: Poster 874P (Abstract
4031). Hall E.
This study assessed 354 patients with ovarian cancer undergoing
BRCA1 and BRCA2 full sequencing and large rearrangement DNA
analysis using the Tumor BRACAnalysis CDx® test. The results
show that, of the 354 samples analyzed, 93 (26.3 percent) tested
positive for a pathogenic mutation; 57 were found in BRCA1 and 37
in BRCA2. Of the pathogenic mutations detected, 93.6 percent
were sequencing variants and 6.4 percent were large
rearrangements. These findings highlight the utility of the
Tumor BRACAnalysis CDx test to accurately detect BRCA mutations in
patients with ovarian cancer.
Title: The molecular landscape of genome
instability in prostate cancer.Presenter:
Kirsten Timms, Ph.D.Date: Monday, Oct.
10, 2016. 1:00-2:00 p.m.Location: Poster
115P (Abstract 3247). Hall E.
In this study, DNA from 95 prostate cancer (PC) tumors was
analyzed to generate homologous recombination deficiency (HRD) and
Microsatellite instability (MSI) and cell cycle progression (CCP)
scores. Additionally, 45 DNA damage repair (DDR) genes were
sequenced and were considered non-functional if both alleles were
mutated and/or deleted. If the second allele was intact, these
genes were considered defective but functional. The results
showed that non-functional DDR genes (CDK12, PALB2, RPA1, ATM, and
BRCA2) were observed in seven tumors and DDR gene defects in eight
genes were observed in 11 tumors. Importantly, the HRD score
was significantly associated with DDR mutation status, Gleason
score and CCP score. A significant proportion of aggressive
prostate tumors carry molecular signatures associated with response
to therapies targeting DDR deficiencies or to immune-therapeutics.
This study demonstrates the importance of assessing both
alleles when identifying prostate tumors with DDR gene mutations.
In the study, an HRD score of ≥20 identified three times as
many potential responders to HRD-dependent therapies compared to
non-functional DDR gene mutations.
Title: Characteristics of homologous
recombination deficiency (HRD) in paired primary and recurrent
high-grade serous ovarian cancer.Presenter:
Jai Patel.Date: Monday, Oct. 10, 2016.
1:00-2:00 p.m.Location: Poster 113P
(Abstract 3290). Hall E.
In this study, the myChoice® HRD test was used to evaluate
paired primary and recurrent tumors from 54 patients with
high-grade serous ovarian cancer (HGSOC), the vast majority of whom
were treated with adjuvant carboplatin and paclitaxel. The
objective was to determine if changes in the genomic profile of
primary and recurrent tumors might impact the myChoice HRD
score. The results showed that there were no significant
differences in the genomic markers evaluated between primary and
recurrent tumors. Importantly, the myChoice HRD test was not
impacted by changes in the genomic profile. This finding suggests
that testing recurrent HGSOC tumors would not alter treatment
strategies relative to analysis of the primary tumor.
Title: Homologous recombination
deficiency (HRD) score shows superior association with outcome
compared to its individual score components (LOH, TAI, and LST
scores) in platinum treated serous ovarian
cancer.Presenter: Jerry Lanchbury,
Ph.D.Date: Monday, Oct. 10, 2016. 1:00-2:00
p.m.Location: Poster 112P (Abstract
2504). Hall E.
The myChoice HRD score is the sum of three independent measures
of HRD, including loss of heterozygosity (LOH), telomeric-allelic
imbalance (TAI) and large-scale state transitions (LST). This
study compared the myChoice HRD score to its individual score
components (LOH, TAI, and LST). The results showed that
the myChoice HRD score is a superior prognostic marker of HR
deficiency than the individual scores. There were a
significant number of discrepancies between the myChoice HRD score
and the individual component, which demonstrated a risk of both
false positives and negatives. These findings support the use
of myChoice HRD, rather than the individual biomarkers, to inform
treatment decisions for patients.
About Tumor BRACAnalysis CDx®Tumor BRACAnalysis
CDx is a companion diagnostic test for identifying both germline
and somatic cancer-causing mutations in
the BRCA1 and BRCA2 genes. Currently, Tumor
BRACAnalysis CDx is a CE-marked genomic test designed to detect the
presence of a BRCA1 or BRCA2 gene mutation in
ovarian tumor tissue. Additionally, Myriad is
actively collaborating with leading pharmaceutical companies and
academic centers to further develop Tumor BRACAnalysis CDx as a
companion diagnostic for use with certain PARP inhibitors,
platinum-based drugs and other chemotherapeutic agents.
About myChoice® HRDMyriad's myChoice HRD is the
most comprehensive homologous recombination deficiency test to
detect when a tumor has lost the ability to repair double-stranded
DNA breaks, resulting in increased susceptibility to DNA-damaging
drugs such as platinum drugs or PARP inhibitors. The myChoice
HRD score is a composite of three proprietary technologies: loss of
heterozygosity, telomeric allelic imbalance and large-scale state
transitions. Positive myChoice HRD scores, reflective of DNA
repair deficiencies, are prevalent in all breast cancer subtypes,
ovarian and most other major cancers. In previously published
data, Myriad showed that the myChoice HRD test predicted drug
response to platinum therapy in certain patients with
triple-negative breast and ovarian cancers. It is estimated
that 1.4 million people in the United States and Europe who are
diagnosed with cancers annually may be candidates for treatment
with DNA-damaging agents.
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 presentation of data from four clinical studies at
the 2016 European Society for Medical Oncology annual meeting to be
held Oct 7-11, 2016 in Copenhagen, Denmark; key poster
presentations highlighting the myChoice HRD and Tumor BRACAnalysis
companion diagnostic tests; 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; 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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