Myriad RBM Launches New Immunoassay Services Based on the Ultrasensitive Simoa(TM) Platform
March 05 2015 - 7:05AM
Myriad RBM, a wholly owned subsidiary of Myriad Genetics, Inc.,
(Nasdaq:MYGN) today announced the launch of immunoassay services
based on the ultrasensitive Simoa™ (single molecule array) platform
developed by Quanterix. The Simoa platform enables the accurate
measurement of protein biomarkers that were previously difficult or
even impossible to detect in blood samples.
"The Simoa platform is an exciting new tool that is 100 to 1,000
times more sensitive than conventional tests for blood-based
protein biomarkers and will open up new avenues of clinical
research," said Ralph McDade, president of Myriad RBM. "We believe
Simoa will significantly accelerate biomedical discoveries by
providing researchers with valuable insights into both the
underlying mechanisms of disease and the safety and efficacy of
pharmaceuticals."
Initially, Myriad RBM will offer Simoa assay services for the
study of inflammatory and autoimmune diseases. The Company has
manufactured and validated Simoa-based quantitative immunoassays
for interleukin-6 (IL-6) and tumor necrosis factor alpha
(TNF-alpha) that are available from its CLIA-certified laboratory
in Austin, Texas. Each assay includes carefully designed
calibrators and controls to provide multiple measurements of
quality, precision and accuracy. Myriad RBM plans to add more
Simoa-based immunoassays throughout the year.
The Simoa platform adds to Myriad RBM's long-standing track
record of scientific excellence and commitment to providing high
quality immunoassay research services. For more than 13 years, the
Company has been a leading provider of multiplex immunoassay
testing services to the biopharmaceutical industry and has earned a
reputation for quality, a broad menu of assays and exceptional
customer service.
"Understanding the incredible role of quantifying ultra-low
concentrations of protein biomarkers in human blood samples and
their linkage to the complex mechanisms of a disease has the
potential to revolutionize the field of medicine as we know it,"
said Kevin Hrusovsky, executive chairman of Quanterix. "We are very
pleased to be collaborating with Myriad RBM and to be working
together to provide access to these important new developments in
healthcare."
The Quanterix Simoa technology has been available to researchers
since early 2014 following the successful validation of the tool's
ability to measure multiple proteins simultaneously at the single
molecule level using its novel technology. The unprecedented
sensitivity of Simoa is the result of digital counting of chemical
binding events that occur based on standard immunoassay
chemistry.
About Simoa™
The Simoa platform uses single molecule measurements to access
previously undetectable proteins. With this unprecedented
sensitivity and full automation, Simoa offers significant benefits
to both research and clinical testing applications. Simoa is a
trademark of Quanterix.
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 is a leading molecular diagnostic company
dedicated to making a difference in patients' lives through the
discovery and commercialization of transformative tests to assess a
person's risk of developing disease, guide treatment decisions, and
assess risk of disease progression and recurrence. Myriad is
focused on strategic initiatives to grow existing markets,
diversify through the introduction of new products, including
companion diagnostics, and expand internationally. 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 Lung
Cancer, BRACAnalysis CDx, HRD, Vectra and Prolaris are trademarks
or registered trademarks of Myriad Genetics, Inc. 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 relating to Myriad RBM's launch of
immunoassay services based on the Simoa™ (single molecule array)
platform developed by Quanterix; the sensitivity of the Simoa
platform versus conventional tests for blood-based protein
biomarkers; the initial offering of the Simoa assay services for
the study of inflammatory and autoimmune diseases; our belief that
the Simoa platform will significantly accelerate biomedical
discoveries by providing researchers with valuable insights into
both the underlying mechanisms of disease and the safety and
efficacy of pharmaceuticals; and the Company's strategic directives
under the caption "About Myriad Genetics." 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 or will not
continue to increase at historical rates; risks related to our
ability to transition from our existing to new testing services,
including unexpected costs and delays; risks related to changes in
the 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; risks related to public concern over our 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 Annual Report on Form 10-K for the fiscal year ended
June 30, 2014, 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.
CONTACT: Media Contact:
Ron Rogers
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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