Population-Calibrated Gene Characterization:
Cancer Penetrance Among BRCA1/2 Mutation Carriers

Phenotypic characterization of rare disease genes poses a significant challenge, but the need to do so is clear: clinical management of such patients depends crucially on an accurate characterization of the genetically predisposed disease, including its penetrance, natural history and response to treatment. We propose a formal yet practical method for controlling for ascertainment bias when estimating disease penetrance using data on high risk individuals. This approach avoids the need to model the ascertainment criteria met by each study participant. Instead, the likelihood is adjusted by a factor that involves the distributions of variables instrumental in the ascertainment process in the general population and in the high risk data. As an example, we derive ascertainment--corrected estimates of cancer penetrance for carriers of the breast cancer susceptibility genes BRCA1 and BRCA2. The Bayesian analysis we employ incorporates a modified segregation model and prior data on penetrance derived from the literature. Markov chain Monte Carlo methods are used for inference.

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