Myriad Presents Clinical Data on Myriad myRisk(TM) Hereditary Cancer Test at ASCO
June 02 2014 - 7:05AM
Myriad Genetics, Inc. (Nasdaq:MYGN) today presented several
clinical studies on the Myriad myRisk⢠Hereditary Cancer test at
the 2014 American Society of Clinical Oncology (ASCO) annual
meeting in Chicago, Illinois. Among the important new findings is
that the myRisk test detects significantly more deleterious
mutations than single cancer tests and helps solve the overlap
dilemma that exists among hereditary cancer syndromes.
"There is robust evidence that hereditary cancers are caused by
mutations in many genes and testing for only one hereditary cancer
syndrome may lead to missed mutations," said Richard J. Wenstrup,
M.D., chief medical officer of Myriad. "The Myriad myRisk test
solves this dilemma by evaluating 25 clinically significant genes,
which detects more deleterious mutations and people at risk for
hereditary cancers."
The Myriad myRisk Hereditary Cancer test uses next-generation
sequencing technology to evaluate 25 clinically significant
hereditary cancer genes associated with eight major hereditary
cancers including: breast, colon, ovarian, endometrial, pancreatic,
prostate, gastric cancers and melanoma. The myRisk test results are
combined with a patient's personal and family history of cancer and
medical society guidelines into a single comprehensive report for
the physician, which makes it easier for physicians to tailor
treatment plans for patients depending on their level of risk.
A summary of the key Myriad studies featured at ASCO
follows.
Multi-gene panel testing in patients
suspected to have Lynch syndrome. |
Matthew Yurgelun. (Podium
Presentation; S100a). |
This study evaluated the outcomes of testing with the myRisk
test in 1,260 patients with a history of hereditary colon cancer.
Results show that 27 percent of mutation carriers identified by the
myRisk test had mutations in genes not normally associated with
hereditary colon cancer. Importantly, more than one third of the
additional mutations found were in the BRCA1 and BRCA2 genes, which
further demonstrates the overlap that exists between the hereditary
breast and colon cancer syndromes.
A study of ovarian cancer patients tested with a 25-gene
panel of hereditary cancer genes. Lucy Langer. (Podium
Presentation; Location S100a)
Results from this study of 648 patients show that 15.4 percent
of patients with ovarian cancer had a mutation that was detected by
the Myriad myRisk Hereditary Cancer 25-gene panel. Of these, 59.6%
percent of patients had mutations in BRCA1 and BRCA2, 34.6% had
mutations in the other hereditary cancer genes in the panel,
including hereditary colon cancer genes Testing patients with the
myRisk Hereditary Cancer panel increased the number of positive
test results in ovarian cancer patients by 63 percent over BRCA1
and BRCA2 testing alone.
Analysis of patients with two hereditary cancers
(breast/ovarian or colon/endometrial) who met NCCN genetic testing
criteria after their first cancer. Jennifer Saam (Poster
1542).
In this study, patients with a history of two associated cancers
were evaluated to determine what percentage of patients met
National Comprehensive Cancer Network (NCCN) criteria for genetic
testing after their first cancer diagnosis, but who did not receive
a test result until after their second cancer diagnosis. The
majority of patients in this study had at least 5 years between
their first and second cancers. For 9,982 patients with breast and
ovarian cancer who were evaluated, the overall rate of BRCA1 and
BRCA2 mutations was 22 percent. Of these, only 56 percent of
patients diagnosed with breast and ovarian cancer met the NCCN
criteria for genetic testing after their first cancer. Among 941
patients with colon and endometrial cancer who were evaluated, 28
percent had mutations in the genes associated with hereditary colon
cancer. Of these, 65 percent of patients met NCCN criteria for
genetic testing after their first cancer. These findings underscore
the importance of diagnosing patients with hereditary cancer
syndromes after their first cancer so that a second cancer can be
prevented or identified early.
About Myriad myRisk Hereditary Cancer
Testing
Myriad's myRisk Hereditary Cancer test uses next-generation
sequencing technology to evaluate 25 clinically significant
hereditary cancer genes associated with eight major hereditary
cancers including: breast, colon, ovarian, endometrial, pancreatic,
prostate, gastric cancers and melanoma.
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, Prolaris, Myriad myPath, Myriad myPlan
and 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 the presentation of the
Myriad myRisk Hereditary Cancer clinical study data at the 2014
ASCO Annual Meeting; the ability of the Myriad
myRisk test to detect significantly more deleterious mutations than
single gene tests and help to solve the overlap dilemma that exists
among hereditary cancer syndromes; 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
(908) 285-0248
rrogers@myriad.com
Investor Contact: Scott Gleason
(801) 584-1143
sgleason@myriad.com
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