Myriad Announces HRD Companion Diagnostic Collaboration With Tesaro
March 24 2014 - 7:05AM
Myriad Genetics, Inc. (Nasdaq:MYGN) today announced that Tesaro,
Inc. will use Myriad's novel HRD (homologous recombination
deficiency) test to identify tumor types that may respond to its
investigational poly-ADP ribose polymerase (PARP) inhibitor,
niraparib, currently in Phase 3 clinical development. Specific
terms of the deal were not disclosed.
"The biology of cancer is complex and increasingly the goal of
oncology is to use a companion diagnostic to pair a tumor type with
the targeted activity of a specific medicine. Prior studies have
shown that only a subset of patients will respond to PARP
inhibitors. HRD is the most comprehensive test to identify those
patients who might respond to treatment," said Jerry Lanchbury,
Ph.D., chief scientific officer at Myriad. "The HRD test is
engineered to look for evidence of genomic disrepair, which appears
as a DNA scar. We believe using the HRD test may capture an
enhanced number of responders to treatment with the exciting new
class of PARP inhibitors."
The research agreement with Tesaro is Myriad's fifth
collaboration with a major pharmaceutical company to evaluate HRD.
Myriad estimates the global market for an HRD test could exceed $3
billion as oncologists move toward personalized medicine and
targeted therapies.
"As an innovation-focused company, we are leading the way in
developing breakthrough companion diagnostics that have the
potential to create significant value for patients and physicians,"
said Lanchbury. "We also strive to be the research partner of
choice. Myriad has a proven track record of providing our
pharmaceutical partners with what they need to move their products
forward and achieve success."
About HRD (Homologous Recombination
Deficiency)
Myriad's proprietary HRD test detects when a tumor has lost the
ability to repair double-stranded DNA breaks resulting in increased
susceptibility to DNA-damaging drugs. High HRD scores are prevalent
in all breast cancer subtypes and most other major cancers. In
previously published data, Myriad showed that the HRD test
predicted drug response to platinum therapy in triple-negative
breast cancer patients. It is estimated that 490,000 people in the
United States who are diagnosed with cancers annually are
candidates for treatment with DNA-damaging agents.
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's
molecular diagnostic tests are based on an understanding of the
role genes play in human disease and were developed with a
commitment to improving an individual's decision-making process for
monitoring and treating disease. Myriad is focused on strategic
directives to introduce new products, including companion
diagnostics, as well as expanding internationally. For more
information on how Myriad is making a difference, please visit the
Company's website: www.myriad.com.
Myriad, the Myriad logo and Prolaris, Myriad myPath, Myriad
myPlan, Myriad myRisk, 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 Tesaro's evaluation of the
Company's novel HRD (homologous recombination deficiency) test to
identify tumor types that may respond to Tesaro's investigational
poly-ADP ribose polymerase (PARP) inhibitor, niraparib, currently
in Phase 3 clinical development; the Company's belief that using
our HRD approach has the potential to capture an enhanced number of
responders to treatment with the exciting new class of PARP
inhibitors; the Company's estimates of the global market for an HRD
test exceeding $3 billion as oncologists move toward personalized
medicine and targeted therapies; and the Company's strategic
directives under the caption "About Myriad Genetics." These
"forward-looking statements" are management's present 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 described in the forward-looking
statements. These risks include, but are not limited to: the
risk that sales and profit margins of our existing molecular
diagnostic tests and companion diagnostic services may decline or
will not continue to increase at historical rates; risks related to
changes in the governmental or private insurers reimbursement
levels for our tests; the risk that we may be unable to develop or
achieve commercial success for additional molecular diagnostic
tests and companion diagnostic services in a timely manner, or at
all; the risk that we may not successfully develop new markets for
our molecular diagnostic tests and companion diagnostic 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 companion diagnostic services
tests and any future tests 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 increased
competition and the development of new competing tests 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; risks related
to changes in intellectual property laws covering our molecular
diagnostic tests and companion diagnostic 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 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
(801) 584-3065
rrogers@myriad.com
Investor Contact:
Scott Gleason
(801) 584-1143
sgleason@myriad.com
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