Until additional scientific studies are performed that will allow the development of guidelines, women found to be carrying the gene must be informed of the lack of proven treatment and surveillance measures before consenting to a course of action. Because nothing is known as of yet about the sensitivity, specificity and reliability of the genetic tests, and little is known about the effectiveness of genetic or psychosocial counseling in this context, genetic screening should only be available to individuals who agree to join peer reviewed, approved research protocols. Nonetheless it is imperative that such studies should be made available to those in the identified community willing to participate and, ultimately, that such studies should be widely available, easy to access in both urban and rural areas and prepared to handle the magnitude of requests for testing. Until such time as the reproducibility, sensitivity, specificity and predictive value of tests are known, the Food and Drug Administration should not approve commercially available testing. Gathering the information and establishing the protocols that are needed MUST be accomplished through coordination and cooperation among researchers, health care providers, industry, insurers, government and the affected public.
Research is needed to establish better methods of detection and monitoring.
We believe that a national coordinating committee that includes representatives of various interests including consumers should define the research questions, establish research protocols, prioritize spending and maintain continuing oversight over the process. Decision making at all levels of the process must include consumers. Women who participate in research protocols help find answers that benefit all women.