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

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

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

3 replies »

  1. 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 the multiple severe problems with current medical care to harass totally innocent providers of information?

  2. 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.

  3. 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 that whatever we’d come up with was plausible enough to warrant testing.
    The more tools at the patient’s disposal the better. Under the sponsorship of under regulated corporate health care, the era of do it yourself health care has already arrived – at the very least, for patients with diseases that are particularly difficult and time consuming to diagnose and treat. When it’s all about “the market,” then the reality is that sick people and their families are first and foremost “consumers” who need to be as personally well informed and personally well equipped to gather and makes sense of information as possible.
    Better that untrained lay people pay close attention to their difficult cases than no one.