Myriad Genetics, Inc. (NASDAQ:MYGN), a leader in molecular
diagnostics and personalized medicine, today announced three poster
presentations that will be featured at the 40th European Society
for Medical Oncology (ESMO) meeting being held Sept. 25 to 29, 2015
in Vienna, Austria. The presentations include new studies on the
myChoice™ HRD and Tumor BRACAnalysis CDx™ companion diagnostic
tests and final results from the EMPATHY-P clinical utility study
on Prolaris®.
"Myriad continues to place a strong emphasis on molecular
diagnostic research with the goal of enabling personalized medicine
and improving patient outcomes. We are presenting exciting new data
on the unique ability of our companion diagnostics to identify the
highest number of patients who may benefit from drugs that target
the DNA-repair pathway, such as PARP inhibitors," said Jerry
Lanchbury, Ph.D., chief scientific officer, Myriad. "We're
also presenting the final results for the EMPATHY-P study that show
the Prolaris test provides essential clinical information to help
physicians select men with prostate cancer who are good candidates
for active surveillance versus those who need more medical
treatment based on a genetic evaluation of their tumor."
The list of key Myriad presentations at ESMO (#ECC2O15)
follows.
myChoice™
HRD
Title: DNA Repair Deficiencies in Ovarian Cancer:
Genomic Analysis of High Grade Serous Ovarian Tumors from the NOVA
Study.
Date: Saturday, Sept. 26, 2015: 4:45 to 6:45 p.m.
CEST.
Location: Hall C, Poster P108.
Homologous recombination deficiency was assessed on tumors
obtained from 318 patients enrolled in the NOVA study, a Phase 3
clinical trial evaluating the PARP inhibitor niraparib as a
treatment in patients with platinum-sensitive ovarian
cancer. The results show that 100 percent of patients with a
germline BRCA mutation and 55 percent of patients without a BRCA
mutation were HRD positive as determined by the myChoice HRD
test. Importantly, the myChoice HRD test, which uses three
novel algorithms of DNA damage (LOH, LST, TAI), more clearly
defined the HRD positive population in ovarian cancer than did LOH
alone. These findings support the use of the myChoice HRD test
to more effectively identify patients who may benefit from therapy
with DNA-damaging agents, such as platinum drugs and PARP
inhibitors.
Tumor BRACAnalysis CDx™
Title: Next Generation Sequencing of BRAC1 and BRCA2
Genes in Ovarian Tumors Captures Germline Mutations and Expands the
Potential Treatment Group for the PARP Inhibitor
Olaparib.
Date: Saturday, Sept. 26, 2015: 4:45 to 6:45 p.m.
CEST.
Location: Hall C, Poster P116.
This study assessed the ability of Tumor BRACAnalysis CDx, a
tumor-based next generation sequencing (NGS) test, to detect
germline BRAC1/2 mutations in patients with high-grade serous
ovarian cancer versus germline testing using Sanger sequencing in a
reference laboratory. Tumor tissue was available from 54
patients to evaluate the Tumor BRACAnalysis CDx test. In all
54 cases, Tumor BRACAnalysis CDx correctly identified the
deleterious BRAC1/2 mutations, demonstrating 100 percent
sensitivity. The study also showed that tumor cells have de
novo somatic mutations not identifiable via germline testing
alone. For example, Tumor BRACAnalysis CDx found 12 somatic
BRCA1/2 mutations, which represents an increase of 22 percent over
germline testing in a sample set that had been specifically
enriched for germline mutations. Importantly, patients with
germline and tumor BRAC1/2 mutations showed similar treatment
response to olaparib, suggesting that tumor testing effectively
identifies patients appropriate for treatment with PARP
inhibitors.
Prolaris®
Title: Potential Reduction of Overtreatment of Localized
Prostate Cancer Using a Cell Cycle Gene Expression Assay (Prolaris)
in Biopsy Specimens: Results from the European Multi-Center
EMPATHY-P Study.
Date: Monday, Sept. 28, 2015: 4:45 to 6:45 p.m.
CEST.
Location: Hall C, Poster P072.
The EMPATHY-P study evaluated the Prolaris test in 502 patient
biopsy samples to determine the aggressiveness of prostate cancer
in these newly diagnosed patients from five European countries
including: Italy, Germany, Spain, Switzerland and the UK. The
patients' biopsy samples also were evaluated using standard
clinical pathology methods (D'Amico/AUA risk stratification) that
were then compared to the Prolaris test results. The EMPATHY-P
data show that overall the Prolaris test identified 54 percent of
the European men with a risk profile that was different than would
be expected using standard clinical pathology. Specifically,
the EMPATHY-P study demonstrated that the Prolaris test score found
24 percent of European men had less aggressive prostate cancer and
30 percent of patients had more aggressive disease compared to
standard clinical pathology measurements. These data demonstrate
that the Prolaris test score can be used to personalize risk
assessment for men with localized prostate cancer and identify good
candidates for active surveillance.
About myChoice™ HRD
Myriad'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.
About Tumor BRACAnalysis
CDx™
Myriad's Tumor BRACAnalysis CDx is a companion diagnostic test
for identifying both germline (hereditary) and somatic (tumor)
cancer-causing mutations in the BRCA1 and BRCA2 genes. Tumor
BRACAnalysis CDx has undergone significant analytic validation and
has been shown to identify 44 percent more patients with
cancer-causing BRCA1/2 mutations compared to germline testing
alone. Myriad is actively collaborating with leading
pharmaceutical companies to develop Tumor BRACAnalysis CDx as a
companion diagnostic for use with certain PARP inhibitors,
platinum-based drugs and other chemotherapeutic agents. The
test is currently available in Europe and will be performed at the
Company's Munich laboratory. Prescribing physicians will
receive Tumor BRACAnalysis CDx test results in approximately two
weeks.
About Prolaris®
Prolaris is a prognostic test that measures the expression level
of genes involved with tumor proliferation to predict disease
outcome. Prolaris is the only test that provides insight into
meaningful oncologic endpoints by predicting 10-year prostate
cancer-specific mortality, thereby guiding medical management.
About Myriad Genetics
Myriad 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, 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 Statement
This 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 our companion
diagnostics to identify the highest number of patients who may
benefit from drugs that target the DNA-repair pathway, such as PARP
inhibitors; the ability of the Prolaris test to provide essential
clinical information to help physicians select men with prostate
cancer who are good candidates for active surveillance; the
effectiveness and benefits of myChoice HRD, Tumor BRACAnalysis CDx
and Prolaris in patient testing; 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 in 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.
CONTACT: Media Contact:
Ron Rogers
(908) 285-0248
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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