On December 6, 2013, 23andMe posted a notice saying they are suspending health-related genetic tests to comply with the FDA’s regulatory review. People who bought the tests before November 22, 2013, will still have access to their results. 23andMe hopes to offer health-related results in the future. The ancestry-related genetic tests and raw genetic data will still be available now. Click here for the complete notice.

On one level, the many genetic testing and ancestry services that currently exist are amazing and are opening incredible doors. For a good overview of Genomic Testing from the Centers for Disease Control and Prevention, click here.

On another level, the first solution should be access to original birth certificates (OBCs) that would allow adopted people the basic civil right to know their own histories. (I’ve written about the need for OBC access here.)

Until our legislators come to their senses and allow adoptees this basic human right, genetic technology at least sheds some light on otherwise dark corners.

I’ve written several times about DNA testing and its value to adoptees, first/birth parents, and others who have gaps in their histories. You can read  “DNA, Pandora’s Box, and Answers?”, “DNA Testing, Adoption, and Outrage,” and DNA Testing and Adoption: Filling In Many Missing Pieces.”

One of the most popular services, 23andme, provides a range of services related to genetics. As the website says, you can discover your ancestral origins and trace your lineage and find out what percentage of your DNA comes from populations around the world (East Asian, sub-Saharan African, British Isles, etc.). There is a family tree tool that allows connection with genetically-related relatives, and some astonishing connections among first/birth families have been made that way.

23andMe also allows you to find out inherited traits (such as lactose intolerance and male pattern baldness), carrier status of certain diseases (for example, cancer), health risks, and drug responses. It doesn’t include all diseases or all health risks, but it does provide some substantial information.

As a result of the genetic health testing service, 23andMe recently received a warning letter from the Food and Drug Administration.

You can see the complete letter here.

Here is an excerpt:

“The Food and Drug Administration (FDA) is sending you this letter because you are marketing the 23andMe Saliva Collection Kit and Personal Genome Service (PGS) without marketing clearance or approval in violation of the Federal Food, Drug and Cosmetic Act (the FD&C Act)…

(Y)our company’s website at http://www.23andMe.com/health (most recently viewed on November 6, 2013) markets the Personal Genome Service for providing ‘health reports on 254 diseases and conditions,’ including categories such as “carrier status,” “health risks,” and “drug response,” and specifically as a “first step in prevention” that enables users to “take steps toward mitigating serious diseases” such as diabetes, coronary heart disease, and breast cancer. Most of the intended uses for PGS listed on your website, a list that has grown over time, are medical device uses under section 201(h) of the FD&C Act. Most of these uses have not been classified and thus require premarket approval or de novo classification, as FDA has explained to you on numerous occasions.

Some of the uses for which PGS is intended are particularly concerning, such as assessments for BRCA-related genetic risk and drug responses (e.g., warfarin sensitivity, clopidogrel response, and 5-fluorouracil toxicity) because of the potential health consequences that could result from false positive or false negative assessments for high-risk indications such as these. For instance, if the BRCA-related risk assessment for breast or ovarian cancer reports a false positive, it could lead a patient to undergo prophylactic surgery, chemoprevention, intensive screening, or other morbidity-inducing actions, while a false negative could result in a failure to recognize an actual risk that may exist.

…The risk of serious injury or death is known to be high when patients are either non-compliant or not properly dosed; combined with the risk that a direct-to-consumer test result may be used by a patient to self-manage, serious concerns are raised if test results are not adequately understood by patients or if incorrect test results are reported.”

Health literacy is an issue in America, where people fail to follow instructions, misunderstand dosage, or get confused about a diagnosis. I’m sure there is some validity to the FDA’s position, though I also believe that most people who would use 23andMe would also consult with a doctor, who would then order additional tests.

Many 23andMe lawyers have no doubt been working hard in response to the letter. The information on the web page currently is vague:

press release

23andMe Statement Regarding FDA Warning Letter

“We have received the warning letter from the Food and Drug Administration. We recognize that we have not met the FDA’s expectations regarding timeline and communication regarding our submission. Our relationship with the FDA is extremely important to us and we are committed to fully engaging with them to address their concerns.”

A New Yorker article this week notes that “many doctors who want medically relevant genetic information about a patient get that information by asking her to sign up with 23andMe. Meanwhile, this company’s cheap, widespread testing, which has gathered genetic, ancestry, and health data from nearly five hundred thousand people, has created a rich medical source of risk information.”

It’s been a huge source of information for adopted adults and for first/birth families in terms of creating connections, as well as allowing them to fill in previously missing information on medical forms. “Unknown” is no fun to post on a medical history.

At this point, 23andMe is still taking orders for its kits, still posting numerous disclaimers  about test results, and still urging consumers to see their doctors. Lawyers are looking into their response to the FDA. A change.org petition has been started. A petition to the White House is up and running. 23andMe has 15 working days from November 22 to respond to the FDA letter.

In addition to 23andMe, here are some other sites to explore and consider:

www.FamilyTreeDNA.com

www.mixedrootsfoundation.org/global-adoptee-genealogy-project

https://genographic.nationalgeographic.com

http://groups.yahoo.com/group/AdoptionDNA

Let’s hope that 23andMe will be allowed to continue safely providing this revolutionary, life-changing service, to those who have few other options of accessing medical information. Let’s hope that other accurate, cost-effective services become available as well.

And let’s continue to work toward  adoptees having access to both their original birth certificates and their own medical history.

DNA Test kits from 23andme.com