After a period of study, the FDA earlier this year lifted its order blocking 23andMe, allowing it to be used by U. Mark Huffman has been a consumer news reporter for ConsumerAffairs since He covers real estate, gas prices and the economy and has reported extensively on negative-option sales. He was previously an Associated Press reporter and editor in Washington, D. Sign up to receive our free weekly newsletter. We value your privacy.
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Close Menu. Email Address Subscribe. Yes Not now. Leave your feedback. Share on Facebook Share on Twitter. What diseases can 23andMe tell me about? Do these tests work better for some ethnic groups than others?
Do I need a doctor to do this? Is 23andMe my only option? Clinical laboratories and blood banks provide essential public health services in aiding the medical practitioner by furnishing information invaluable in the diagnosis and treatment of disease. If you want any kind of lab test done in Maryland, you have to get it through a medical practitioner — or a court order.
First, Maryland law prohibits anyone from offering or advertising for lab business except to medical professionals. The law expressly states:. A person may not directly or indirectly advertise for or solicit business in this State for any medical laboratory, regardless of location, from anyone except a physician, hospital, medical laboratory, clinic, clinical installation, or other medical care facility.
But say you find out about the test anyway. Its administrative code provides:. A laboratory may not perform a laboratory test, except a cholesterol or HDL-C, without obtaining written or electronic authorization from: 1 A court of law; 2 A doctor of medicine, osteopathy, podiatric medicine, or dentistry; or 3 Another person authorized to order laboratory tests under the Annotated Code of Maryland.
And the Maryland Department of Health stepped up enforcement of that statute and regulation in , explaining its in year-end report:. This enforcement mandated that over fifty websites, offering direct to consumer laboratory testing, add a disclaimer prohibiting ordering for Maryland residents.
Direct to Consumer testing is dangerous because it occurs without physical examination or medical assistance. It can also lead to inaccurate diagnoses and a higher cost for the consumer for irrelevant testing.
Thank you Judy for this comparison. I had always wondered what the differences were between NY and MD law. The Maryland Department of Health and Mental Hygiene in particular seems to be moving backwards while the scientific world is moving forward. It can also lead to inaccurate diagnosis and a higher cost for consumer for irrelevant testing. If DTC testing is detrimental, then show us the scientific evidence. There is no good scientific study to date that proves that 23andMe tests are dangerous — quite the opposite.
It merely shows possible or potential correlations based on your own genetic code that each one of us possesses. Who owns this information anyway? We know that there is much work to be done, especially in the diagnosis of complex diseases. We also see that consumers understand these limitations based on recent investigations reported by researchers at the November meeting of the American Society of Human Genetics in San Francisco.
The tests are conducted in a CLIA certified laboratory so the actual data is not being questioned. Genealogists around the world are ordering DTC tests in record numbers and if they had experienced any significant medical harm, then I think we would have heard about it.
The Center for Disease Control has not issued any medical alerts as far as I know I know even though this 23andMe test has been under surveillance for several years. What makes the state of Maryland so adamant that legislation is necessary at this point in time? It would seem that education rather than support of outdated laws is what is needed.
I would encourage people in MD and NY to write to their governor and state legislature. These laws are particularly paternalistic and are not based on any sound scientific studies.
This goes a bit deeper than these tests being dangerous. This kind of testing over time makes closed adoption records obsolete and Maryland for whatever reason thinks that all people born before the year of are not able to handle their own information.
There certainly is a major league impact on adoptees of this kind of policy, Patrice. Funny you should mention the year Good luck getting that info yourself! I have done DNA testing as Ancestry. That may also give you information about adoptive persons. So 23 and me is no different in that respect. Could not agree more! So where do we sign the petition? Knowing full well there will be lobbyists nipping at the bills heals to monopolize on the profit aspect of all this pent up demand!!!
Way to go NY! Perhaps 23andMe will change their way of doing business and offer a genealogy-only DNA test. Thanks, Judy, for bringing this issue to light. From the wording of the law, it sounds like the test would be okay with a prescription from an MD. Since the law only exempts cholesterol tests, it obviously allows scripts for a wide variety of tests. Why not order 23andme with a script? What am I missing?
My Doc and Endo both said no arguing not necessary! No one needs to know their DNA or details to heal Autoimmune conditions. Just a couple of quick thoughts. Answer, control. All these types of restrictions will do is to slow down the rate in which people will buy these tests.
It will not stop them. Not on these grounds. The good news for Maryland residents? No one is very far from a bordering state where friends live. I would like to add here as well that if 23andme does find out that you are in MD, they will invalidate your test results.
I had mine invalidated about 5 days before getting my results. I fully intend to see if we have a case against the state of MD and additionally will be contacting lawmakers to change this archaic law!
I am live in maryland and I am very interested in 23andme type testing and I am deeply offended by this intrusion into what should be personal business. Writing everyone I can. Encouraged that Department of Health and Mental Hygiene is actively seeking public input. They are going to get mine. Do you know how they found out you were in MD? Do they ask for address when you register the kit? They find out in any number of ways: your address, your phone number, the address of your credit card when you buy the kit, the postmark when you send back the kit.
Any of those will trigger 23andMe to refuse to process the kit because of the Maryland law. Choose another state? That was when they told me that since I had just told them I live in MD, they have to cancel out my account. They ended up refunding my money. I think this law is incredibly asinine and really offensive. If I want to be a sucker, I should have the right to be a sucker on this count, and the state should stay out of it.
Whatever justification there was for the rule is long gone now. I should clarify that the legislation is not new, but the stepping up of enforcement based on unsubstantial claims is what makes no sense to me.
A public outcry can make a difference. What would happen if you went into Pennsylvania, Massachusetts, Vermont or Canada? They all share borders with NY state as well.
Canada, I concede, might well be a problem, as I have no idea if international orders are accepted. So guilty as charged! Of course, this also begs another question. This is interstate commerce, so how do these states have any right to regulate it in the first place?
Unless Congress steps in and says it wants to occupy an area as being interstate commerce, then there is room for state regulation alongside any federal rules. So let me get this straight after reading this article twice: THE moment I buy the kit from 23andme at approx. New York will certainly allow you to take it with you to a neighboring state or country!
Belated thanks for the excellent post with references. As a Maryland resident, I was quite miffed to learn about this just this past weekend and have taken action via social media: Twitter, Facebook and LinkedIn; FB and Twitter include local and state level politicians.
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