NCCN Updates Guidelines for Hereditary Colon Cancer Testing
March 04 2014 - 7:05AM
Myriad Genetics, Inc. (Nasdaq:MYGN) today is pleased to note that
the National Comprehensive Cancer Network (NCCN) has revised its
medical guidelines to expand Lynch syndrome screening. Lynch
syndrome is the most common cause of hereditary colon cancer in
adults.
Myriad believes the new guidelines will dramatically expand the
number of patients eligible for hereditary colon cancer testing,
especially among at-risk asymptomatic patients for whom screening
has historically been limited based upon prior guidelines and a
lack of insurance reimbursement. Some of the key aspects of the new
guidelines include:
- A recommendation that all patients who meet a five percent or
greater risk threshold for Lynch syndrome are appropriate for
testing;
- A recommendation against sequential testing for the five Lynch
syndrome genes in lieu of panel testing; and
- An acknowledgement that patients with cancer can proceed
directly to sequencing tests without a complicated tissue screening
algorithm.
"We view the expansion of guidelines to broaden access to Lynch
syndrome screening as a major victory for patients and their
families. It is the culmination of a significant amount of work by
patient advocates and healthcare professionals to bring about this
important advancement in guidelines," said Patrick Lynch J.D. M.D.,
professor in the Department of Gastroenterology at the University
of Texas MD Anderson Cancer Center. "Our hope is that these
guidelines are broadly accepted by the medical community, which
would dramatically expand the number of at-risk, asymptomatic,
patients who have access to the life-saving information associated
with Lynch syndrome testing."
Myriad estimates that approximately 30 percent of newly
diagnosed colorectal cancer patients, 100 percent of newly
diagnosed endometrial cancer patients, and three percent of
asymptomatic patients will now qualify for Lynch syndrome testing
under the new medical guidelines. These estimates are based upon
Myriad's research collaborations with multiple research
institutions and through the development of the PREdiction model
for Mismatch repair Mutations (PREMM1,2,6) model by Sapna Syngal
M.D. at the Dana Farber Cancer Institute and Fay Kastrinos M.D. at
Columbia University.
"Our experience is that restrictive and confusing hereditary
colon cancer guidelines have limited patient access compared to
those in hereditary breast and ovarian cancer. This is a major step
to expand access to genetic testing for all patients at risk for
hereditary colon cancer," said Mark Capone, president of Myriad
Genetic Laboratories. "Myriad will continue to work with
professional organizations to identify appropriate patients,
especially as we launch our next generation test, Myriad myRisk
Hereditary Cancer, which has been shown to detect over 60 percent
more deleterious mutations than standard of care in patients at
risk of hereditary colon cancer."
March is Colon Cancer Awareness Month
Myriad will be observing colon cancer awareness month in March
by working closely with healthcare providers across the country to
further raise awareness about testing for hereditary colon cancer.
Additionally, the company is supporting several Colon Cancer
Alliance Undy 5000 events this year, including two in March. The
Sacramento event was Saturday, March 1 and the San Diego event is
Saturday, March 8. To learn more about Undy 5000 visit:
http://support.ccalliance.org/site/PageServer?pagename=undy_landing
"As we support the new NCCN guidelines, we also recognize there
is need to educate patients and physicians about the risks of
hereditary colon cancer and options for genetic testing," said
Capone. "Colon Cancer Awareness month is the perfect time for
people to ask if there are early, multiple or rare colon cancers
that run in their family. If so, they may be at increased risk for
cancer and should have a conversation with their physician."
About Lynch Syndrome
Lynch syndrome is a hereditary condition that dramatically
increases a patient's risk for certain types of cancer including
colorectal, gastric, endometrial, ovarian, and other cancers.
Patients with a deleterious mutation in one of the five Lynch genes
(MLH1, MSH2, MSH6, PMS2, and EPCAM) have up to an 82 percent
lifetime risk of colorectal cancer and a 71 percent lifetime risk
of endometrial cancer. The average age of diagnosis of a person
with Lynch syndrome is 45, as compared to the average age of 72 for
a person diagnosed with colon cancer in the general population.
Genetic testing can detect harmful mutations allowing patients to
take preventive steps such as more frequent colonoscopies, which
can significantly reduce their risk of colon cancer.
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 Myriad myRisk Hereditary Cancer, 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 new guidelines
dramatically expanding the number of patients eligible for
hereditary colon cancer testing, especially at-risk asymptomatic
patients for whom screening has historically been limited based
upon prior guidelines and a lack of insurance reimbursement;
expansion of guidelines broadening access to Lynch syndrome
screening; broad acceptance of the guidelines by the medical
community dramatically expanding the number of at-risk,
asymptomatic patients who have access to the life-saving
information associated with Lynch syndrome testing; estimates that
approximately 30 percent of newly diagnosed colorectal cancer
patients, 100 percent of newly diagnosed endometrial cancer
patients, and three percent of asymptomatic patients will now
qualify for Lynch syndrome testing under the new medical
guidelines; the new guidelines being a major step to expand access
to genetic testing for all patients at risk for hereditary colon
cancer; the Company continuing to work with professional
organizations to identify appropriate patients, especially as the
Company launches its next generation test, Myriad myRisk Hereditary
Cancer, which has been shown to detect over 60 percent more
deleterious mutations than standard of care in patients at risk of
hereditary colon cancer; the Company observing colon cancer
awareness month in March by working closely with healthcare
providers across the country to further raise awareness about
testing for hereditary colon cancer; the Company supporting several
Colon Cancer Alliance Undy 5000 events this year, including two in
March; 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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