Download Cancer-Related Genetic Testing and Counseling by Institute of Medicine, National Cancer Policy Forum PDF
By Institute of Medicine, National Cancer Policy Forum
These complaints of a workshop provided to the Institute of Medicine's (IOM) nationwide melanoma coverage discussion board on March 30, 2007, are the results of discussion board discussions approximately genetic trying out and counseling at its conferences on June sixteen and October 30, 2006. these discussions, led by way of discussion board participants Betty Ferrell and Patricia Ganz, famous that genetic trying out and counseling have gotten extra advanced and demanding for informing sufferers and households of hazards and merits of convinced classes of motion, and but prepared specialist courses are briefly supply.
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Additional resources for Cancer-Related Genetic Testing and Counseling
I didn’t try every single permutation, but I tried two. If you fill out the risk factor questionnaire saying no to every risk factor except that you are Ashkenazi Jewish, it recommends multisite testing. That costs $695. Dr. Greene: And that recommendation is made even in the absence of any history of cancer either in yourself or your family? Ms. Javitt: That’s right. If you say no to everything except Ashkenazi Jewish ancestry they still recommend testing. You receive a personalized report. The company states that it has board-certified genetic counselors on staff and provides posttest consultation as part of the service.
There is a basic group of requirements that all genetic testing laboratories must meet, including validation and documentation of procedures, personnel, and the like. Furthermore, because genetic tests are complex, the labs are considered high-complexity laboratories by CMS. Most high-complexity laboratories under CLIA are subject to something called a specialty area, which means there is a specification of quality control and personnel requirements, and, perhaps most importantly, proficiency testing requirements.
Test kits are also subject to FDA regulations. Those regulations involve more than just looking at labeling and good manufacturing practices. The FDA reviews the analytic and clinical validity of the test kit. Either premarket notification, which is like premarket review, or something more formal called the premarket approval application is required. Only a few genetic tests, about five or six, have gone the test kit route and been approved by the FDA. Otherwise, of the more than 1,000 genetic tests, the vast majority are what are termed laboratory-developed assays or home brew assays.