Myriad Genetics to Launch MELARIS(TM) - a Predictive Medicine Test For Melanoma
- Hereditary Skin Cancer Test Is Myriad's Fourth Commercial Product -
SALT LAKE CITY, Sept. 27 /PRNewswire/ -- Myriad Genetics, Inc.
(Nasdaq: MYGN) announced today that it plans to launch a predictive medicine
test for malignant melanoma, a deadly form of skin cancer, in November 2001.
The test, named MELARIS(TM), is used to assess an individual's risk of
developing melanoma based on the detection of inherited mutations in the p16
(CDKN2A) gene.
Scientists at Myriad Genetics discovered that the p16 gene is involved in
the genesis of many types of cancer, including melanoma, leukemia, lymphoma
and cancers of the breast, ovary, bone, brain and bladder. The p16 gene
functions as a molecular brake during a key step in the cell division process.
When the gene is mutated, it loses its braking function and uncontrolled cell
growth may result. The p16 gene is the one of the most important tumor
suppressors discovered to date and is involved in approximately half of all
cancers.
"MELARIS(TM) is the fourth predictive medicine product utilizing Myriad's
highly accurate, high-throughput, DNA sequencing technology," said Gregory
Critchfield, M.D., President of Myriad Genetic Laboratories, Inc. "This new
test will provide the same reference standard quality test result to
researchers and clinicians in the field of skin cancer that has previously
been achieved in breast cancer, ovarian cancer, colon cancer and uterine
cancer with Myriad's existing cancer predictive medicine products."
Myriad discovered that inherited mutations in the p16 gene could
dramatically increase an individual's risk of developing melanoma. More than
250 research studies have since investigated and confirmed the association
between mutations in the p16 gene and melanoma. Individuals who carry a
mutation in the p16 gene, resulting in a positive MELARIS(TM) test, have an
estimated lifetime risk that is more than 50 times higher than the risk for
those in the general population. With such important healthcare implications,
the wide availability of the MELARIS(TM) test is expected to provide a major
step forward in the care of individuals at increased risk of melanoma.
Prevention of melanoma is the goal of the MELARIS(TM) predictive medicine
product. Melanoma is lethal in 86% of cases in which it has spread to other
sites in the body. When diagnosed early, melanoma patients have a survival
rate of better than 90%. Patients identified at high risk may be placed on a
regular schedule of office visits to check for changing moles or other early
signs of disease. This process of frequent surveillance along with the
removal of suspicious moles and lesions can often prevent melanoma.
Melanoma is a serious health problem in the United States. Over
51,000 patients will be diagnosed with melanoma in the year 2001. Even more
startling is the rapid increase in the number of melanoma cases per year.
Melanoma is increasing at a rate of over 4% per year, and has become one of
the fastest growing cancer types in the United States. Myriad believes that
approximately 10% of these cases will have a strong family history of the
disease. Individuals with a family history of melanoma should discuss the
benefits of MELARIS(TM) with their physician.
Myriad will begin accepting samples for testing nationwide in November,
2001. The MELARIS(TM) predictive medicine test will be sold in the United
States by Myriad's existing 75-person oncology product sales force. Worldwide
product rollout of the MELARIS(TM) predictive medicine test will follow its
introduction in the United States. Myriad has been awarded 12 U.S. patents on
the p16 gene.
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