The Myriad myRisk® Hereditary Cancer Test Identifies 60 Percent More Deleterious Mutations in Patients with Endometrial Canc...
March 18 2016 - 7:05AM
Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced it will
present two important new studies at the 2016 Society for
Gynecologic Oncology annual meeting in San Diego, Calif.
The data demonstrate the ability of the myRisk® Hereditary
Cancer test to identify deleterious mutations in patients with
endometrial cancer. Additionally, a different study showed
the superior ability of the combined three biomarker myChoice® HRD
test to predict survival in patients with platinum treated ovarian
cancer.
“Endometrial cancer is the most frequent gynecologic
cancer and a significant number of these cases are due to
mutations in hereditary cancer genes,” said Johnathan
Lancaster, M.D., Ph.D., chief medical officer, Myriad Genetic
Laboratories. “Our new data show that gene
panel testing can identify many more patients with harmful
mutations than testing Lynch Syndrome genes alone.
The additional information provided by the myRisk
Hereditary Cancer test will help physicians
optimize care for their patients.”
Details about the featured Myriad presentations at SGO are
below. Follow Myriad on Twitter via @MyriadGenetics and stay
up-to-date with the meeting by using the hashtag #SGOMtg.
myRisk Hereditary Cancer Presentation – Endometrial
Cancer
Title: Hereditary cancer panel testing in an
unselected endometrial carcinoma cohort.Date:
Saturday, March 19, 2016: 7:50 to 9:55 a.m.
PT.Location: Podium – Abstract
6261.Presenter: Kari Ring, MD Anderson Cancer
Center.
This study evaluated the prevalence of cancer predisposition
gene mutations in 381 endometrial cancer patients who had
previously undergone tumor testing to screen for Lynch
Syndrome. Patients were tested for mutations in 25 cancer
genes using the myRisk Hereditary Cancer test. The results
showed that 9.2 percent of endometrial cancer patients had a
deleterious mutation, including 5.8 percent with a mutation in a
Lynch Syndrome gene and 3.4 percent in 10 non-Lynch genes.
Multi-gene panel testing with myRisk demonstrated the ability to
identify 60 percent more mutations, several of which are associated
with ovarian and uterine cancers. These findings support gene
panel testing to identify patients who may be missed by current
Lynch Syndrome testing alone.
myChoice HRD Presentation
Title: Homologous recombination deficiency
(HRD) score shows superior association with outcome compared to its
individual score components (LOH, TAI and LST) in platinum treated
serous ovarian cancer.Date: Saturday, March 19,
2016: 7:50 to 9:55 a.m. PT.Location: Podium –
Abstract 6286. Presenter: Gordon B. Mills, M.D.,
Ph.D., MD Anderson Cancer Center.
This study compared the predictive ability of the combined three
biomarker myChoice HRD score to the three independent measures of
homologous recombination deficiency that comprise the assay
including: loss of heterozygosity (LOH) score, telomeric-allelic
imbalance (TAI) score, and large-scale state transitions (LST)
score. The results showed that the combined myChoice HRD
score predicted progression-free survival (p=2.2x10-6) and overall
survival (p=1.0x10-8) in patients with platinum-treated ovarian
cancer. In a bivariate analysis none of the individual
biomarkers (LOH, TAI and LST) reached statistical significance for
either progression free survival or overall survival. In this
study, myChoice HRD was shown to be a superior predictor of
clinical outcomes to any of the individual score components
including LOH, TAI and LST.
About Myriad myRisk® Hereditary Cancer
TestingThe Myriad myRisk Hereditary Cancer test uses
next-generation sequencing technology to evaluate 25 clinically
significant genes associated with eight hereditary cancer sites
including: breast, colon, ovarian, endometrial, pancreatic,
prostate and gastric cancers and melanoma. For more
information visit: myriad.com.
About myChoice® HRDMyriad's
myChoice HRD is the first homologous recombination deficiency test
that can 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.
High 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 1.8 million people in the
United States and Europe who are diagnosed with cancers annually
may be candidates for treatment with DNA-damaging agents. For
more information visit: myriad.com.
About Myriad GeneticsFor more than 25 years,
Myriad Genetics Inc., has been 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, myRisk Hereditary Cancer, myChoice, myPlan,
BRACAnalysis CDx, Tumor BRACAnalysis CDx, myChoice HRD, Vectra 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
related to data to be presented at the 2016 Society for Gynecologic
Oncology annual meeting in San Diego; the additional information
provided by the myRisk Hereditary Cancer test helping physicians
optimize care for their patients; 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, 2015, 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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