Myriad Introduces Enhanced BRACAnalysis® Test for Exceptionally High-Risk Breast Cancer Patients
New BART™ Technology Detects Rare DNA Rearrangements in BRCA1 and BRCA2 Genes
Salt 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."
About Myriad
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.
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