Myriad RBM, a wholly-owned subsidiary of Myriad Genetics, Inc.
(NASDAQ:MYGN), today announced that its DiscoveryMAP® platform
successfully identified combinations of 15 protein biomarkers
associated with cardiovascular (CV) events or death in people with
pre-diabetes or early type 2 diabetes, according to a study
published by the journal Circulation.
"Cardiovascular diseases are one of the leading causes of deaths
globally," said Riccardo Perfetti, M.D., vice president Medical
Affairs, Global Diabetes at Sanofi, which sponsored the study. "We
are optimistic that as we move toward personalized medicine,
cardiovascular biomarkers will help us predict future events and
possibly develop tailored treatment plans for patients that will
save more lives."
In the paper titled, "Identifying Novel Biomarkers for
Cardiovascular Events or Death in People with Dysglycemia,"
researchers at the Population Health Research Institute and Sanofi
used Myriad RBM's DiscoveryMAP platform to evaluate 237
cardiometabolic biomarkers in serum from 8,401 participants in the
completed Outcome Reduction with Initial Glargine Intervention
(ORIGIN) trial. Results of the assays were analyzed to identify
biomarkers that provided better estimates of the risk of future CV
events or death than could be estimated from standard clinical and
biochemical data alone. The analysis identified a novel
combination of 10 biomarkers that, when added to clinical risk
factors, can find people with dysglycemia who are at higher risk of
heart attack, stroke or CV death. Moreover, these 10
biomarkers, plus an additional five, had the greatest impact on the
ability to predict death.
"Our study is one of the largest scientific investigations in
history to identify specific cardiovascular biomarkers associated
with serious cardiovascular outcomes, including heart attacks,
strokes and death," said Hertzel Gerstein, M.D., lead study
investigator and deputy director, Population Health Research
Institute. "Our results highlight the potential value of
cardiovascular biomarkers for identifying people with dysglycemia
at the highest risk of future events."
DiscoveryMAP is a comprehensive, quantitative, immunoassay
service product that measures more than 300 human proteins. It is
the culmination of 15 years of assay development for cytokines,
chemokines, metabolic markers, hormones, growth factors, tissue
remodeling proteins, angiogenesis markers, acute phase reactants,
cancer markers, kidney damage markers, CNS biomarkers and other
important circulating proteins.
"This is another demonstration that our DiscoveryMAP technology
can successfully identify panels of biomarkers with important
diagnostic and prognostic applications. We believe that the
protein biomarkers characterized by the PHRI and Sanofi teams may
identify people at higher risk for cardiovascular events," said
Ralph McDade, Ph.D., president of Myriad RBM. "Based on these
very encouraging findings, we are pursuing additional research
collaborations to further develop panels of protein biomarkers with
application for cardiometabolic disorders."
About ORIGIN
ORIGIN (Outcome Reduction with Initial Glargine Intervention)
was a seven-year landmark cardiovascular outcomes trial, evaluating
insulin glargine versus standard care in over 12,500 individuals
who were at high CV risk with pre-diabetes or early type 2 diabetes
mellitus. ORIGIN was sponsored by Sanofi and was designed,
conducted, and analyzed by the Population Health Research Institute
and its international network of diabetes and cardiovascular
disease experts.
About Human DiscoveryMAP®
DiscoveryMAP is for those who seek a thorough understanding of a
compound's biological activity, efficacy and safety profile as well
as the disease or condition being addressed. The DiscoveryMAP
service products help increase the odds of identifying novel
protein biomarker patterns in drug development or diagnostic
discovery projects. These data can support critical go/no-go
decisions or identify candidate panels for potential companion
diagnostics. Once a pattern is discovered, it can be seamlessly
converted into a CustomMAP for high volume sample processing
resulting in better, more efficient clinical trials. For more
information visit: http://rbm.myriad.com/discoverymap/
About Myriad RBM
Myriad RBM is a wholly owned subsidiary of Myriad Genetics,
Inc. Myriad RBM's biomarker discovery platform provides
clinical researchers and healthcare providers with reproducible,
quantitative, multiplexed data for hundreds of proteins to advance
drug development and patient care. The Company's proprietary Multi
Analyte Profiling (MAP) technology offers preclinical and clinical
researchers with broad, cost-effective analyses of multiple
proteins from a single, small sample volume. MAP technology
also supports Myriad RBM's drive to develop companion diagnostics
in areas of unmet medical need such as neuropsychiatry, nephrology
and immunology. More information about Myriad RBM can be found
at www.myriadrbm.com.
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, Myriad myRisk, myRisk, myRisk Hereditary Cancer,
myChoice, myPlan, BRACAnalysis CDx, Tumor BRACAnalysis CDx,
myChoice HRD, Vectra, Prolaris, and DiscoveryMAP 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 Myriad RBM's DiscoveryMAP®
technology identifying novel biomarkers that may predict increased
risk of cardiovascular events in patients with diabetes and other
cardiovascular applications; and the Company's strategic directives
under the captions "About Human DiscoveryMAP," "About Myriad RBM"
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, 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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