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.

The material comprises not just the clinical and medical elements but in addition team and compensation concerns, between others. Drs. Ferrell and Ganz proposed that the discussion board may supply an invaluable evaluate of some of the vital implications of those concerns through retaining and reporting a workshop at the topic. They volunteered to paintings with employees to prepare and lead this type of workshop. The schedule for the workshop is reproduced within the appendix to those lawsuits. It comprises the displays of the invited audio system and the reviews of audio system, discussion board individuals, and others in attendance as transcribed and edited to do away with redundancies, grammatical error, and another way lead them to extra readable. Cancer-Related Genetic trying out and Counseling : Workshop Proceedings summarizes the workshop.

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Example text

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.

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