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Germline-inactivating mutations in the breast and ovarian cancer susceptibility gene BRCA1 are associated with a substantial increase in the risk of cancer.1 One of the possible outcomes of genetic testing for BRCA1 is the finding of an alteration in the BRCA1 coding region for which the risk of cancer has not been determined. These alterations have been termed unclassified variants (UCVs) or variants of uncertain significance. Most of these alterations are missense changes (Breast Cancer Information Core database, http://research.nhgri.nih.gov/bic/). We have developed a functional assay that aids in the determination of the association of cancer with BRCA1 UCVs.2,3 The assay measures the …
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