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GEN News Highlights : Oct 27, 2010

Myriad to Conduct BRCA Mutation Testing for Abbott’s Phase III Study

BRACAnalysis® test will be used to identify mutations in patients to be enrolled in the trial.

Myriad Genetics signed an agreement with Abbott Laboratories to conduct BRCA1 and BRCA2 mutation testing on patients to be enrolled in a Phase III multicenter, global study for the treatment of metastatic breast cancer. While the companies are not divulging the drug candidate under investigation, they say that a deal was previously signed covering Phase II testing of the same drug.

Myriad will use its BRACAnalysis® test to identify the presence of germline mutations in breast cancer patients to be enrolled in the study. It will determine the mutation status and provide standard test reports to the clinicians at each study site.

BRACAnalysis was developed by Myriad Genetics to assess a woman’s risk for hereditary breast and ovarian cancer. A woman who tests positive with BRACAnalysis has, on average, an 82% risk of developing breast cancer during her lifetime and a 44% risk of developing ovarian cancer, the company explains.

The company points to research published in the Journal of the National Cancer Institute that has shown presymptomatic individuals who have a high risk of developing breast cancer can reduce their risk by approximately 50% with appropriate preventive therapies. They also note work published in The New England Journal of Medicine that has shown presymptomatic individuals who carry gene mutations can lower their risk of developing ovarian cancer by approximately 60% with appropriate preventive therapies.