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Over the Counter Genetic Testing Kits Put on Hold by F.D.A

Posted May 16 2010 10:00am

I was greatly concerned to read an article by Andrew Pollock in the San Francisco Chronicle on 5/12/10 saying that 7500 Walgreen Stores were going to sell genetic testing kits. It was with great relief that two days later an article in the New York Times, also by Anderew Pollock, said that the F.D.A.had  told Pathway Genomics that they were going to investigate whether these kits required regulation.

I certainly hope the F.D.A does not allow any of these kits to be sold. They are sold now on the Internet by more than one company and these, too, should be carefully regulated. A great deal of harm could come from non-medical people thinking they had the gene for a particular disorder. This could lead to unnecessary abortions and all kinds of problems.

I had a teenage patient many years ago who was originally diagnosed as having Duchenne Muscular Dystrophy. On physical examination, I knew that the diagnosis was wrong and in repeating his muscle biopsy there was no question that the youth had another type of dystrophy with a much better outcome and a much longer life expectancy. When I told his parents of the change in diagnosis, they apparently didn't hear that their son would live many years longer with fewer complications.  Instead, they got into a heated argument about who was responsible for the disorder. The mother was the probable carrier for the Duchenne gene, whereas Limb-Girdle dystrophy can be caused by a gene from each parent. It was hard to see such a reaction from parents.

This is the kind of thing that could happen if parents did a saliva genetic test from an over-the-counter kit. Many other problems could also occur, so I hope the people at F.D.A do a detailed investigation and don't allow any of these kits to be sold either online or over the counter.

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