SALT LAKE CITY, UT--(Marketwire - December 22, 2008) - Myriad Genetics, Inc. (NASDAQ: MYGN)
(www.myriad.com) announced today that it is launching its sixth molecular
diagnostic product, Prezeon™. The product will be marketed to
researchers and physicians to assist them in understanding the status of
the PTEN gene, which plays a major role in critical cell-signaling
pathways. These pathways have been implicated in cancer progression and
provide important information that may guide therapeutic decisions. The
price per Prezeon test is $500.
Myriad discovered the PTEN gene, as reported in the journal Nature Genetics
in 1997, and has been awarded four U.S. patents and has several additional
patents pending on the PTEN gene, protein and antibody, as well as their
use in molecular diagnostic assays. PTEN has been shown to be involved in
many cancers, including cancer of the prostate, breast, colon, lung, brain,
skin, uterus, kidney, bladder, blood, ovary and lymphatic system.
PTEN is a major component of the mTOR and EGFR cell-signaling pathways that
are targeted by many cancer drugs and it is believed to play an important
role in determining a patient's sensitivity to a range of cancer
chemotherapeutics. PTEN loss is associated with resistance to certain drugs
and sensitivity to others, suggesting the potential to determine the most
effective chemotherapy for patients. In prostate cancer, PTEN loss has been
correlated with onset of androgen-independent growth in tumors. In breast
cancer treatment, several recent studies have shown an association between
PTEN loss of function and resistance to Herceptin® in HER2-positive
patients. PTEN loss is also associated with resistance to doxorubicin and
sensitivity to mTOR inhibitors. In colorectal cancer care, PTEN loss is
associated, along with KRAS, in non-response to Erbitux®. In lung cancer
patients and patients with glioblastoma, loss of PTEN is correlated with
response to EGFR inhibitor drugs such as Iressa®. In leukemia, loss of
PTEN expression has been linked to resistance to doxorubicin and gamma
secretase inhibitors.
Prezeon is an analysis of protein expression by immunohistochemistry to
determine whether the PTEN gene is functioning properly. PTEN is a tumor
suppressor gene that is linked with cell regulation and programmed cell
death in otherwise healthy tissue. Loss of PTEN function is commonly
associated with cancers of many types. For example, in recent clinical
studies of metastatic prostate cancer, patients with high levels of PTEN
rarely progressed even after 2 1/2 years, while those with low levels of
PTEN usually saw progression of the disease. PTEN loss is also associated
with disease progression and increased immunoresistance in glioblastoma. In
breast cancer, PTEN loss is a predictor of poor prognosis and risk of
disease progression and has also been associated with breast cancer that is
aggressive and high grade. In animal models, PTEN inactivation accelerated
lung tumorigenesis. In lung cancer patients treated with Iressa, PTEN
expression was associated with longer overall survival. In melanoma,
studies in human tumors found a correlation between PTEN loss and shorter
disease-free survival and overall survival.
"As a global leader in molecular diagnostics, we are pleased to introduce
Prezeon and we believe it will play an important role in the prognosis of
several types of cancer as well as in the chemotherapy choice made by a
physician in determining the optimal route to therapeutic efficacy," said
Peter Meldrum, President and Chief Executive Officer of Myriad Genetics,
Inc. "Personalized medicine products are important in the care and
treatment of individual patients and also have an expanding role in
reducing healthcare costs to Americans by providing an efficient means of
selecting cost-effective therapeutic options."
PTEN Technical Background
The PTEN gene (also known as MMAC1) is a tumor suppressor located at 10q23.
PTEN is a key regulator of cell-signaling pathways that regulate growth and
survival. Specifically, PTEN is a lipid phosphatase that converts PIP3
(phosphatidylinositol 3-4-5 triphosphate) to PIP2 (phosphatidylinositol 3-4
biphosphate). This enzymatic activity is antagonized by PI3K
(phophoinositide 3-kinase) and it is the balance of these two activities
which tightly regulates the levels of phosphorylated phosphatidylinositol.
When the levels of PIP3 rise, downstream pathway targets are activated
leading to cell growth. In tumors, PTEN is often nonfunctional resulting in
the expression of the active form of the proto-oncogene Akt, cell cycle
progression and inhibition of apoptosis. Akt phosphorylation activates mTOR
(mammalian target of rapamycin) resulting in an up-regulation of cell cycle
proteins.
Prezeon™ is a trademark of Myriad Genetics, Inc. All other trademarks
mentioned above are the property of their respective owners.
Myriad Genetics, Inc. is a healthcare 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.
MYGN-G
This press release contains "forward-looking statements" within the meaning
of the Private Securities Litigation Reform Act of 1995, including
statements relating to the marketing of Prezeon to researchers and
physicians to assist them in understanding the status of the PTEN gene; the
price per Prezeon test; the Company's belief that Prezeon will play an
important role in the prognosis of several types of cancer as well as in
the chemotherapy choice made by a physician in determining the optimal
route to therapeutic efficacy; the ability of Prezeon to assist researchers
and physicians in understanding the status of the PTEN gene and its role in
critical cell-signaling pathways; the importance of critical
cell-signaling pathways in cancer progression; the ability of Prezeon to
play an important role in the prognosis of several types of cancer as well
as in the chemotherapy choice made by a physician in determining the
optimal route to therapeutic efficacy; and the ability of Prezeon to
determine whether the PTEN gene is functioning properly. These
forward-looking statements are based on management's current expectations
and are subject to certain risks and uncertainties that could cause actual
results to differ materially from those set forth in or implied by
forward-looking statements. 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 additional 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 not 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, 2008,
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.