Myriad Genetics Launches New Molecular Diagnostic Test
TheraGuide 5-FU May Help Patients Avoid Severe Toxic Reactions to Chemotherapy
Salt Lake City, UT, Jul 26, 2007—Myriad Genetics, Inc.
(NASDAQ: MYGN)
(www.myriad.com) announced
today that it has introduced a new product, TheraGuide 5-FU™, to
help predict which cancer patients are likely to suffer serious toxic
reactions to the drug 5-Fluorouracil (5-FU) or the oral form of the
drug, capecitabine. More than 500,000 Americans with breast cancer,
colon cancer, skin cancer or head and neck cancer are treated with
5-FU each year. Approximately 30% of those patients experience severe
toxicity.
TheraGuide 5-FU is a comprehensive analysis of the genetic variations
in two genes, DPYD and TYMS, which increase a patient's risk for
toxicity to 5-FU chemotherapy. With the TheraGuide 5-FU test results,
oncologists and their patients can take steps to reduce the risk of
avoidable toxicity, including using alternative therapies, reducing
the size of the dose and increasing patient monitoring for side
effects. TheraGuide 5-FU provides the critical guidance oncologists
need to personalize chemotherapy for their cancer patients who are
being considered for chemotherapy regimens.
"TheraGuide 5-FU is a new personalized medicine test that has the
potential to save many cancer patients from serious toxic reactions to
the medicine that is supposed to help them," said Greg Critchfield,
M.D., President of Myriad Genetic Laboratories, Inc. "TheraGuide
5-FU points the way to the future promise of personalized medicine,
where tests can guide the therapeutic choice for improved patient
care, while limiting the side effects of otherwise efficacious
drugs."
Approximately one third of all patients given 5-FU will experience
dose-limiting toxicity that can be severe to life-threatening. The
majority of these toxic reactions are due to genetic variations in the
DPYD and TYMS genes. The DPYD gene makes the enzyme that is primarily
responsible for metabolizing or breaking down 5-FU and clearing it
from the body quickly. If the DPYD enzyme activity is compromised,
5-FU will be cleared more slowly from the system resulting in a
longer period of exposure to 5-FU and a subsequent increased risk for
toxicity. An estimated 9 million individuals in the U.S. have low
DPYD enzyme activity due to mutations in the DPYD gene.
Thymidylate synthase (TYMS) is an essential enzyme for DNA synthesis.
The chemotherapy drug, 5-FU, binds to the TYMS enzyme, inhibiting its
function. When the TYMS enzyme is inhibited, DNA synthesis does not go
forward and the cell dies. Since cancer cells multiply rapidly,
requiring a high level of DNA synthesis, they are much more sensitive
to thymidine depletion than normal cells. The human TYMS gene has
genetic variations that cause differential production of the TYMS
enzyme. If a variation causes underproduction of TYMS, only a portion
of the 5-FU dose is used to bind to, and inhibit, the TYMS enzyme,
and the rest remains unbound in the body resulting in increased
toxicity. Variations causing overproduction of TYMS enzyme lead to
excess TYMS and insufficient 5-FU to completely inhibit the enzyme
and a resulting loss of efficacy with the 5-FU chemotherapeutic.
Toxicity reactions due to reduced enzyme activity may include
hand-foot syndrome, fever, mucositis, stomatitis and severe diarrhea.
Nausea, vomiting, rectal bleeding and skin changes may also occur.
Neurologic abnormalities include cerebellar ataxia (uncoordinated
muscle movement) and changes in cognitive ability. Elimination of
5-FU from the treatment regimen is usually sufficient to prevent
additional unexpected toxicities.
TheraGuide 5-FU is Myriad's fifth molecular diagnostic product. The
Company is now accepting samples for testing with TheraGuide 5-FU. The
test cost is $1,100 and includes a comprehensive DNA sequence
analysis of the DPYD gene and the important variations in the TYMS
gene. The result is returned to the requesting physician within seven
days of receipt at Myriad.
Myriad Genetics, Inc. is a biotechnology company focused on the
development and marketing of novel therapeutic and molecular
diagnostic products. Myriad's news and other information are
available on the Company's Web site at www.myriad.com.
This press release contains "forward-looking statements" within the
meaning of the Private Securities Litigation Reform Act of 1995. These
forward-looking statements include statements relating to TheraGuide
5-FU's ability to save many cancer patients from serious toxic
reactions to the medicine that is supposed to help them and the
Company's ability to return the result to the requesting physician
within seven days of receipt at Myriad. These risks and
uncertainties include, but are not limited to, our inability to
further identify, develop and achieve commercial success for new
products and technologies; our ability to discover drugs that are
safer and more efficacious than our competitors; our ability to
develop molecular diagnostic products that help assess which patients
are subject to greater risk of developing diseases and who would
therefore benefit from new preventive therapies; the possibility of
delays in the research and development necessary to select drug
development candidates and delays in clinical trials; the risk that
clinical trials may not result in marketable products; the risk that
we may be unable to successfully finance and secure regulatory
approval of and market our drug candidates, or that clinical trials
will be completed on the timelines we have estimated; uncertainties
about our ability to obtain new corporate collaborations and acquire
new technologies on satisfactory terms, if at all; the development of
competing products and services; our ability to protect our
proprietary technologies; patent-infringement claims; 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 in our Annual Report on
Form 10-K for the year ended June 30, 2006, 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.
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