SALT LAKE CITY, Dec. 14, 2010 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (Nasdaq:MYGN) announced today that an article entitled "Prevalence of BRCA1 and BRCA2 Mutations In Women With Carcinoma In Situ of the Breast Referred for Genetic Testing" will appear in the December 2010 issue of the journal Cancer Prevention Research. The study demonstrated that BRACAnalysis® testing of at risk women with breast carcinoma in situ may provide valuable information to guide the physician's medical and surgical strategies for their patients.
Among women referred to Myriad for testing, the authors examined 7,295 non-Ashkenazi women diagnosed with CIS. Approximately 6% of these women had deleterious mutations in either the BRCA1 or BRCA2 genes regardless of personal and/or family history of invasive cancer. Results of the data showed that 10.3% of the CIS patients with both a personal and family history of invasive cancer had BRCA1/2 deleterious mutations.
"This data confirms what physicians have long suspected," stated Mark C. Capone, President of Myriad Genetic Laboratories. "A significant percentage of women with breast carcinoma in situ who have a family history of breast cancer have mutations in the BRCA genes. These women are at particularly high risk for invasive cancers of the breast and ovary. BRACAnalysis® testing helps to identify these women and provides their physician with critical information so that strategies can be designed to lower their cancer risks."
In patients referred for genetic testing, early-onset CIS is associated with a likelihood of carrying BRCA1/2 mutation. When a family history of breast and/or ovarian cancer are also present, testing women with early-onset CIS may increase the likelihood of BRCA1/2 mutation detection, and the opportunity for carriers to consider invasive cancer prevention strategies.
Carcinoma in situ of the breast is an increasingly common diagnosis in American women. Between 1980 and 2001, age-adjusted rates of CIS have increased approximately seven-fold. According to the American Cancer Society, 62,280 new cases of CIS were expected to be diagnosed last year, and CIS accounts for nearly 25% of all new breast cancer diagnoses. Women diagnosed with CIS of the breast have a significantly higher risk of invasive breast cancer compared to the general population.
The current market opportunity for BRACAnalysis® testing among pre-symptomatic women and patients with cancer is estimated to be $800 million annually. Considering the 62,000 newly diagnosed cases of breast carcinoma in situ and the CIS survivors, the Company now estimates that the market opportunity will increase by $100 million annually to a total annual market potential of over $900 million in the United States.
Professional medical society guidelines, such as the American Society of Clinical Oncologists (ASCO), the Society of Gynecologic Oncologists (SGO), and the American College of Obstetricians and Gynecologists (ACOG), articulate risk factors for BRCA gene mutations, which include, among others, breast cancer occurring before age 50, personal or family history of ovarian cancer at any age, personal or family history of male breast cancer, Ashkenazi Jewish ancestry with breast cancer at any age, or the presence of a known BRCA mutation in the family.
About BRACAnalysis®
BRACAnalysis® is a comprehensive analysis of the BRCA1 and BRCA2 genes for assessing a woman's risk for breast and ovarian cancer. A woman who tests positive with the BRACAnalysis® test has, on average, an 82% lifetime risk of developing breast cancer during her lifetime and a 44% risk of developing ovarian cancer. BRACAnalysis® testing provides important information that the Company believes will help the patient and her physician make better informed lifestyle, surveillance, preventive medication and treatment decisions. As published in the Journal of the National Cancer Institute, researchers have shown that pre-symptomatic individuals who have a high risk of developing breast cancer can reduce their risk by approximately 50% with appropriate preventive therapies. Additionally, as published in the New England Journal of Medicine, researchers have shown that pre-symptomatic individuals who carry gene mutations can lower their risk of developing ovarian cancer by approximately 60% with appropriate preventive therapies.
For more information about BRACAnalysis®, please call 1-800-4-MYRIAD, or visit .
About Myriad Genetics
Myriad Genetics, Inc. is a leading molecular diagnostic company focused on developing and marketing novel predictive medicine, personalized medicine and prognostic medicine products. Myriad's news and other information are available on the Company's Web site at .
Myriad, the Myriad logo, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, OnDose, and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-G
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This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to BRACAnalysis® testing of at risk women with breast carcinoma in situ providing valuable information to guide the physician's medical and surgical strategies for their patients; the ability of BRACAnalysis testing to identify women with breast carcinoma in situ who have a family history of breast cancer have mutations in the BRCA genes and to provide them with strategies designed to lower their cancer risks; the increased likelihood of BRCA1/2 mutation detection when a family history of breast and/or ovarian cancer are also present and the opportunity for carriers to consider invasive cancer prevention strategies; the financial market estimates for the current market opportunity and total annual market potential for BRACAnalysis testing among pre-symptomatic women and patients with cancer in the United States; and the Company's belief that BRACAnalysis testing will help the patient and her physician make better informed lifestyle, surveillance, preventive medication and treatment decisions. These "forward-looking statements" are based on management's current 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 set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic products may decline or will not continue to increase at historical rates; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic products in a timely manner, or at all; the risk that licenses to the technology underlying our molecular diagnostic products and any future products are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; risks related to public concern over our products; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of healthcare payment systems; 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; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our products; the risk of patent-infringement claims or challenges of our patents; 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, 2010, 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: Myriad Genetics, Inc. Suzanne Barton, Director, Investor Relations (801) 584-1138 sbarton@myriad.com