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posted by janrinok on Friday October 23 2015, @01:26PM   Printer-friendly
from the simple-solution dept.

23andMe, a consumer genetic testing company, has relaunched its Personal Genome Service, which now includes a more limited selection of test results and has received approval from the U.S. Food and Drug Administration:

The relaunched service will offer FDA-approved tests that show whether an individual carries genes associated with 36 different disorders, such as cystic fibrosis, that could be passed on to a child.

But Dr. Cecile Janssens, a professor of epidemiology at Emory University in Atlanta, said the company still is not testing for the diseases that raised the most concerns for consumers in the past. These included tests for predisposition to common diseases such as heart attack, asthma and hip fractures, for which lifestyle factors are often more important, Janssens said.

The company also does not test for high-risk genetic variants such as BRCA1 and BRCA2 for breast and ovarian cancer and APOE for Alzheimer's, and it does not include pharmacogenetic testing. 23andMe said it is still working with the FDA for approval of those additional tests.

23andMe already offers tests for inherited genetic risks and drug response in other countries such as the United Kingdom, Canada and Sweden.

23andMe revealed that it has received 4 requests for user data from U.S. law enforcement agencies in the past quarter:

Those stats came in the first "transparency report" from the company on Wednesday. At the same time, it launched a new "personal genome service" (PGS) test that it says will provide you with 60 different data points covering "health, ancestry, wellness, and personal."

The transparency report is frustratingly vague. We asked the company how it defined the term "user data" and it told us: "Any personal information relating to one of our customers, including but not limited to name, email address, health, and genetic information." It confirmed that this includes the results of the tests it carries out on your behalf. But we don't know exactly what was asked for, or under what justification.

Likewise, who is "law enforcement"? Does it include the FDA? The company told us: "We've received requests from both state and federal law enforcement organizations. Only two of the four requests were legally valid, one from the FBI and one from a state law enforcement agency." So on at least one occasion the FBI has asked for specific details on an individual. We don't know for a fact it was their DNA tests, but since that is 23andMe's sole function, it's a fair bet.

Previously: FDA Permits Marketing of 23andMe Direct-to-Consumer Genetic Test
Color Genomics Launches a $249 Genetic Test for Breast Cancer Risk


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  • (Score: 2) by takyon on Friday October 23 2015, @10:28PM

    by takyon (881) <reversethis-{gro ... s} {ta} {noykat}> on Friday October 23 2015, @10:28PM (#253835) Journal

    I believe a few PhDs out there will spend their careers trying to destroy forensic science. And if not the common murderer, perhaps spy agencies.

    If your genome is known information, it can be shared and eventually synthesized from scratch. What this means for Joe Schmo Bio is unclear. It could take decades to see any consequences. Politicians and celebrities on the other hand could see more abuse of their DNA.

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  • (Score: 2) by frojack on Saturday October 24 2015, @03:55AM

    by frojack (1554) on Saturday October 24 2015, @03:55AM (#253902) Journal

    These days, people's entire genome is not known, even when they take a DNA sample.
    But, as you suggest that will not last forever.

    Whereas it took 13 years and cost US$3 billion to sequence a human genome for the first time, now even the smallest research groups can complete genomic sequencing in a matter of days. Give it 25 years, there will be an app for that.

    Faking the entire genome, will probably take much longer. So maybe 100 years.

    Then DNA will be pretty useless except for much beyond paternity tests.

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