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From Forbes: "States Crack Down On Online Gene Tests"

New York

Update: See the related story in GenomeWeb News (free sub. required).

Forbes.com published an article today entitled “States Crack Down On Online Gene Tests” that examines New York state’s response to the recent launch of direct-to-consumer (DTC) genetic testing services by companies such as 23andMe, deCODEme, SeqWright, and Navigenics, as well as the behind-the-scenes companies like Illumina and Affymetrix.

Unfortunately, the regulatory environment surrounding DTC genetic services is hazy at best. From the article:

“Over the last six months, New York State’s Department of Health has sent letters raising the specter of fines and jail time to six online gene-testing firms that offer consumers the ability to peer into their genome to assess their future risk of getting diseases such as cancer, heart disease and multiple sclerosis. Often, it turns out, the services offering these DNA deep-dives are doing so without the involvement of a doctor. That puts them on the wrong side of the law.”

Unclear Regulations

I’m still not convinced. I recently wrote an article that reviewed New York’s statutes and regulations regarding DTC testing, and it is far from clear. Additionally, there is almost an entire lack of case law to help interpret these statutes. Ultimately it is a question of statutory interpretation and legislative intent. What did the original drafters of these regulations intend the laws to do, or to protect? How should these laws be interpreted today? These are difficult questions without clear answers, and thus will be the subject of much debate in the near future.

P.S. – I am currently working to find a journal in which to publish my article, so stay tuned for my input on this very controversial topic!

Blaine Bettinger

Intellectual property attorney, genealogist, and author of The Genetic Genealogist since 2007

9 Comments

  1. Blaine–
    You say “Ultimately it is a question of statutory interpretation and legislative intent.” Of course, this is correct, in a perfect legal environment. Unfortunately, the reality is that it’s up to ambitious politicians or short-sighted bureaucrats or both, in the first instance to set up the limits.

    Craig Manson’s last blog post..Texas Death Collection at FamilySearch Labs

  2. Craig – very good point. Something I almost wrote in the post is that I would rather see new legislation that specifically addresses these issues rather than trying to fit cutting-edge technology into decades-old law. But that is, of course, how the system works. It is unfortunate that scientists aren’t more involved in making policy (although I know that scientists are often consulted, I wonder how much influence they have on the process).

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