These clinical management guidelines now recommend that all obstetricians and gynecologists evaluate a patient's risk for hereditary breast and ovarian cancer syndrome as a routine part of their obstetric and gynecologic practice. Because tailored screening and prevention strategies can reduce morbidity and mortality from breast cancer and ovarian cancer, the identification of individuals at inherited risk is important. Practice Bulletin 103 discusses a number of important issues involving strategies to reduce a woman's risk of breast and ovarian cancer if she carries a mutation in BRCA1 or BRCA2. For example, women with BRCA1 or BRCA2 mutations should be offered risk-reducing removal of the ovaries and fallopian tubes by age 40 years or when child-bearing is complete.
"These new guidelines will raise physician awareness of the importance of routine hereditary breast and ovarian cancer assessment," stated Dr. Gregory C. Critchfield, President of Myriad Genetic Laboratories, Inc. "BRACAnalysis testing made available to at risk patients is an important tool in helping to lower their risks of developing cancer."
Germline mutations in BRCA1 and BRCA2 account for the vast majority of families with hereditary breast and ovarian cancer syndrome. BRCA1 and BRCA2 are tumor suppressor genes that encode proteins that function in the DNA repair process. Although individuals with hereditary breast and ovarian cancer syndrome inherit one defective allele in BRCA1 or BRCA2 from their father or mother, they have a second, functional allele. If the second allele becomes nonfunctional, cancer can develop through the accumulation of additional mutations. When evaluating a woman's family history, families with few female relatives may under-represent the family's risk of cancer, and therefore, the guidelines recommend that it may be appropriate to test women with an isolated case of breast cancer at or before the age of 50 years.
Practice Bulletin 103 further notes that many insurance companies, including Medicare, will cover a significant portion of the expense of testing. These clinical guidelines were developed by the ACOG Committee on Practice Bulletins-Gynecology, ACOG Committee on Genetics, and the Society of Gynecologic Oncologists member contributors. ACOG has over 52,000 members and is the nation's leading group of professionals providing health care for women.
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 an 82% risk of developing breast cancer during her lifetime and a 44% risk of developing ovarian cancer. BRACAnalysis provides important information that we believe 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 substantially reduce their risk of breast cancer 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 risk of developing ovarian cancer by approximately 60% with appropriate preventive therapies.
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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 Myriad Genetics, Inc.'s support of The American College of Obstetricians and Gynecologists (ACOG) Practice Bulletin Number 103, dated April 2009, which are clinical management guidelines for all obstetricians and gynecologists; the belief that BRACAnalysis provides important information that will help the patient and her physician make better informed lifestyle, surveillance, preventive medication and treatment decisions; and the ability of the new guidelines to raise physician awareness of the importance of routine hereditary breast and ovarian cancer assessment. 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 we may be unable to further identify, develop and achieve commercial success for new products and technologies; the risk that we may be unable to discover drugs that are safer and more efficacious than our competitors; the risk that we may be unable to develop manufacturing capability for approved products; the risk that sales of our existing molecular diagnostic products may decline or not continue to increase at historical rates; the risk that we may be unable 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; the risk that we may be unable to protect our proprietary technologies; the risk of 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.