Myriad Introduces Enhanced BRACAnalysis® Test for Exceptionally High-Risk Breast Cancer Patients
Myriad Introduces Enhanced BRACAnalysis® Test for Exceptionally High-Risk Breast Cancer PatientsSalt Lake City, August 1, 2006—Myriad Genetics, Inc. (Nasdaq: MYGN) (www.myriad.com) announced today the introduction of the BRACAnalysis® Rearrangement Test, a new molecular diagnostic test in the BRACAnalysis family of products. The added test detects rare, large rearrangements of the DNA in the BRCA1 and BRCA2 genes and will be performed for women with exceptionally high risk who have tested negative for sequence mutations and the common large rearrangements already included in Myriad's test.
BRACAnalysis, Myriad's test for hereditary breast and ovarian cancer incorporates the most thorough full-sequence analysis for gene mutation detection ever employed on a broad commercial scale. More recently, Myriad and others have discovered and published information on an additional type of mutation, known as a large rearrangement, that has not been detectable by commercial DNA sequencing technologies, but only by laborious, manual research-based methods. Such rearrangements are responsible for a small percentage of changes in the two breast cancer genes. In 2002, Myriad added a panel of five common rearrangements to its BRACAnalysis test, accounting for nearly half of the total occurrence of large rearrangements in the two genes. Because large rearrangements are quite rare, a woman meeting the commonly employed selection criteria for BRACAnalysis has less than one half of one percent (0.5%) risk of carrying one of the large rearrangement mutations.
Now, with its new BART technology for large rearrangement detection, Myriad offers an automated, robust test designed to detect all large rearrangement mutations in the BRCA1 and BRCA2 genes, even if they have not been seen previously. As of August 1, 2006, Myriad will conduct the BRACAnalysis Rearrangement Test on patient samples where the individual's personal and family history is indicative of an exceptionally high level of risk, but the sample tests negative for BRACAnalysis. The Rearrangement test will be performed, when indicated, at no additional charge, and is also available for order independently for a fee of $650.
"We are very pleased to introduce an exciting and robust technology to detect these rare rearrangement mutations," said Gregory Critchfield, MD, President of Myriad Genetic Laboratories, Inc. "This work continues Myriad's leadership in providing the best testing possible for individuals at risk for hereditary breast and ovarian cancer through our gold-standard BRACAnalysis product."
Myriad Genetics, Inc. is a biopharmaceutical company focused on the development and marketing of novel healthcare products. The Company develops and markets molecular diagnostic products, and is developing and intends to market therapeutic products. Myriad's news and other information are available on the Company's Web site at www.myriad.com. BRACAnalysis is a registered trademark and BART is a trademark of Myriad Genetics, Inc. in the United States and other countries.
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include the introduction of the BRACAnalysis Rearrangement Test (BART) and the ability of BART to detect rare, large rearrangements of the DNA in the BRACA1 and BRACA2 genes. These forward looking statements are based on management's current expectation and are subject to certain risks and uncertainties that could cause actual results to differ materially from those set forth or implied by forward-looking statements. These include, but are not limited to, uncertainties as to the extent of future government regulation of Myriad Genetics' business; uncertainties as to whether Myriad Genetics and its collaborators will be successful in developing, and obtaining regulatory approval for, and commercial acceptance of, therapeutic compounds; the risk that markets will not exist for therapeutic compounds that Myriad Genetics develops or if such markets exist, that Myriad Genetics will not be able to sell compounds, which it develops, at acceptable prices; and the risk that the Company will not be able to sustain revenue growth for its predictive medicine business and products. These and other risks are identified in the Company's filings with the Securities and Exchange Commission, including the Company's current Report on Form 8-K filed October 28, 2005. All information in this press release is as of August 1, 2006 and Myriad undertakes no duty to update this information unless required by law.