Myriad Genetics Laboratories Inc. and the American College ofSurgeons (ACS) initiated a study to follow outcomes of patients nowundergoing BRCA1 genetic analysis for susceptibility to breast andovarian cancer.
About 1,000 women are expected to participate in the study that willlast as long as it produces significant data, said Susan Watkins, aspokeswoman for Myriad. The company envisions the study lasting10 years.
Myriad is funding the genetic testing and the ACS is taking care ofthe program's administration.
The effort is called the ACS-Myriad BRCA1 Longitudinal Study, orAMBLS. It will address two major questions: Which BRCA1mutations are strongly correlated to the risk of getting the disease,and what is the likely clinical outcome after medical and surgicalintervention.
"The AMBLS study is expected to provide data on the rates ofsecondary cancers and recurrence of cancer following differenttreatments for women who test positive for the BRCA1 mutationscompared to women who do not," Watkins said.
The study will be administered for the ACS by the Sloan-KetteringInstitute for Cancer Research in New York. It will use Myriad'sBRACAone genetic analysis and multi-center patient data base formutational and clinical data.
Myriad last month began beta-site testing of its BRACAone geneticanalysis in 14 U.S. cancer centers. It is a full-sequenced DNA examthat detects mutations in the coding region of a woman's BRCA1gene. Commercial launch of the product is expected later this year. _Jim Shrine
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