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Personal genetic companies back in service

Two direct-to-consumer genetic testing firms, 23andMe and Navigenics gained approvalDna from California regulators this week to continue providing clients access to and interpretations of their personal DNA.

The NY Times reports this morning that, "The licenses, granted to Navigenics and 23andMe, should help defuse a
controversy that began in June when the California Department of Public
Health sent “cease and desist” letters to the two companies and 11
others that offer genetic testing directly to consumers."

The news sparked a heated summer debate over whether consumers should have unbridled access to their DNA or whether a doctor should lead the process.

Here on THCB, Matthew Holt called the move the "first establishment challenge of Health 2.0."

"This is a case where the regulations are running way behind the
technology, and the trade protection organizations of health care
providers are, I’m sure, whispering in the ear of the regulators," Holt
wrote.

Dr. Steven
Murphy over at Gene Sherpa,
however, argues that doctors must be involved and for more regulation
to ensure the quality and integrity of genetic testing.

"I am just shocked and awed that some in the public think that they
can do this on their own without professional help. Do you build your
own home? What about fight your own court cases? Some do their own
taxes … but only when it isn’t complicated. Trust me, this IS
COMPLICATED!"

California officials are satisfied that 23andMe and Navigenics meet
the doctor requirement. So looks like the debate is settled — for now.

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Harvey S. FreyDr. RajPaul Maurice Martin Recent comment authors
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Harvey S. Frey
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It’s absurd that the state allows quacks like astrologers and spiritualists try to tell people their past and future, but attempts to throttle those with a scintilla of scientific accuracy. There are hundreds of clubs and websites devoted to genealogy. Why are they OK, but haplogroup analysis requires a doctor’s approval? These sites provide far more education on the meaning of their findings than I have ever received about a test from any doctor. Indeed, I suspect that few practicing physicians are as knowledgeable about these issues as the people who run the sites. Who ARE these regulators who ignore… Read more »

Dr. Raj
Guest

Mr. Paul Maurice Martin brings up a good point. The fact of the matter is that for the majority of cases the physician is able to diagnose and treat the patient’s condition. This is is because throughout medical training we are taught to “go after the horses before the zebra”. So in fact, a physician will pursue the most common diseases before pursuing the exotic ones. I see nothing wrong with the patient doing their homework and reading up on possible diagnoses and working together with his or her doctor.

Paul Maurice Martin
Guest

My first reaction here is “the more information available to patients the better.” With the kind of time pressure put on physicians by the health insurance industry, doctors rarely if ever have the ability to pay particularly complex cases the kind of attention they warrant. My sister and I needed to do virtually all the research once it became clear that my dx would be difficult to impossible to obtain. We’d go in, for example, asking “Could it be Mastocytosis?” and handing the doctor our research as more and more rare disease candidates were ruled out. Usually the response was… Read more »