Myriad Introduces Enhanced BRACAnalysis® Test for Breast Cancer Patients
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Myriad Genetics, Inc. has announced the introduction of the BRACAnalysis® Rearrangement Test, a 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 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 BART technology for large rearrangement detection, Myriad offers an automated 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 a 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."