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“No DNA for you!”

You remember that episode of Seinfeld with the Soup Nazi? If you didn’t stay on the good side of the soup stand owner, all you got was a stern “No soup for you!” The phrase went viral back before anybody even knew what going viral meant.

The Legal Genealogist can’t help but think that’s probably pretty close to what’s going through the mind of folks who’ve finally decided to get in on DNA testing now that 23andMe has lowered its price for its autosomal testing to $99 — only to discover that, if they live in New York or Maryland, it’s “No DNA for you!”

Seriously.

At least not the kind of DNA testing you get with 23andMe, which includes health-related traits and not just genealogy.

Both states have decided that they need to protect us from ourselves by making sure that, if we get health-related tests of any kind, we get them from state-approved laboratories.

Never mind that you may have no interest at all in the health part of 23andMe’s tests; you can’t take the test in New York and you can’t even buy it if you live in Maryland.

Here’s the story:

New York

Right now, New York State law requires that all specimens obtained within New York State be tested by a laboratory that holds a New York State clinical laboratory permit, if the test has any health related aspects at all. The law specifically forbids any lab that doesn’t have that permit from “accepting specimens from New York state.”1

And, 23andMe advises its customers, the New York Department of Health considers 23andMe’s Personal Genome Service a test requiring a lab license and direct physician involvement.

Now there’s nothing in the law that says you can’t buy a DNA test kit from 23andMe if you live in New York. And the law doesn’t stop 23andMe from shipping the kit to you in New York. So you can order it and receive it in New York.

But the law does say you can’t provide the specimen in New York and have it tested by 23andMe, since it doesn’t have that New York permit. So to be legal, you have to cross the border into New Jersey or Connecticut and spit into the saliva collection tube there.

And you can’t send it in from New York and have it tested even if you spit into the tube in New Jersey or Connecticut. The policy at 23andMe is that any sample arriving in a package postmarked New York is discarded, so that it won’t run afoul of New York law.

The theory behind all of this is that New York has its own Clinical Laboratory Evaluation Program (CLEP), which

seeks to ensure the accuracy and reliability of results of laboratory tests on specimens obtained within the state through on-site inspections, proficiency testing and evaluation of the qualifications of personnel of state permit-holding clinical laboratories and blood banks. The proper performance of diagnostic laboratory tests is a matter of vital concern, affecting the public health, safety and welfare of all NYS residents. 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. Substandard performance of such tests may and has contributed to erroneous diagnoses and/or the selection of inappropriate treatment protocols.2

If 23andMe eventually does get FDA approval for its tests, and it is seeking that approval,3 then New York residents may find testing easier: there’s a new regulatory proposal that would allow some testing at labs that don’t have the New York permits if the lab and its test are FDA-approved.

In the interim, however, it’s a PATH ride across the Hudson or “No DNA for you!” if you want to test with 23andMe. Purely genealogical tests from Family Tree DNA or AncestryDNA aren’t affected by the New York State law. And it doesn’t affect the National Geographic Geno 2.0 testing either.

Maryland

It’s even worse for Maryland residents. For them, it’s always “No DNA for you!” The law there doesn’t let Maryland residents buy direct-to-consumer tests of any kind if they have health aspects. 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.4

So 23andMe can’t even ask for your business if you live in Maryland. But say you find out about the test anyway. You’re not allowed to buy 23andMe’s test because, again, its Personal Genome Service is considered the kind of test that requires direct physician involvement. 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.5

And the Maryland Department of Health stepped up enforcement of that statute and regulation in 2012, 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.6

Once again, these laws do not affect strictly genealogical DNA tests such as those offered by Family Tree DNA and AncestryDNA, or National Geographic’s Geno 2.0 testing.

But the rule does mean that, if you live in Maryland, you can’t even try to connect to your genetic cousins who’ve tested with 23andMe by doing your own test at 23andMe for genealogical purposes. The mere fact that 23andMe gives you health-related information means you’re out of luck.

“No DNA for you!”


 
SOURCES

  1. N.Y. Pub. Health Law § 574, Article 5, Title V.
  2. Clinical Laboratory Evaluation Program,” New York State Department of Health (http://www.wadsworth.org : accessed 22 Dec 2012).
  3. Dick Eastman, “23andMe seeks FDA Approval for Personal DNA Test,” Eastman’s Online Genealogy Newsletter, posted 30 Jul 2012 (http://blog.eogn.com : accessed 22 Dec 2012).
  4. Maryland Code, Health Law § 17-215.
  5. Code of Maryland Regulations, 10.10.06.02 (Authorization to Request Laboratory Tests).
  6. Maryland Department of Health, Fiscal Year 2012 Annual Report & Staffing Analysis, PDF report at 12 (http://dhmh.maryland.gov : accessed 22 Dec 2012).
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