Supportive clinical trials

I'm reading a book at the moment called Beyond Genetics--it attracted my eye in my pile of "I want to read these someday" books surrounding my overfull bookcase. The author suggests that companies offer genetic tests online to boost their numbers of tests, so that eventually their promise that the test actually tests for gene X might be more accurate. Patents run out so rapidly that there's rarely time to get the necessary number of tests done in time--so, offer the test online and get more "patients" in your studies.

Of course, the studies are not controlled (no matching randomized group of people, no physical exams and  blood chemistry, etc.). As I was explaining this idea to a friend, it struck me that these "supportive" clinical trials like the data that pharmaceutical companies collect after a drug is approved for marketing.

Big difference, though, genetic tests are not controlled by the FDA (although some are approved by them) and the samples of DNA sent in by interested consumers adds to the offering company's store of genetic information related to the condition being tested for.  By 2003, the company that owns the genetic tests for BRCA1 and 2 (the "breast cancer genes") is reported  (in Beyond Genetics) to have found an additional 49 genes related to breast cancer among the samples sent to them for DNA analysis. Not a bad return. And by now, they have added many more samples to their stock of tested materials and their false positive/negative rates have probably decreased.

Interesting way to gather information, isn't it?

Marie Godfrey, PhD