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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
(Score: 2) by frojack on Friday October 23 2015, @09:16PM
Dr. Frumkin is a founder of Nucleix, a company based in Tel Aviv that has developed a test to distinguish real DNA samples from fake ones
The reason you can fake a DNA sample if you had access to a DNA profile ONLY because matches tend to be done on a limited set of alleles, corresponding to variations at 13 spots in a person’s genome.
However, if fake DNA is alleged, the lab need only match on a different a set of characteristics. Fakes don't match everything, just a small subset of variations.
(The problem is that there may be no access to the original sample of DNA, and the only remaining crime scene DNA evidence is the profile in the computer. )
Its extremely easy to plant DNA to frame someone at a crime scene to frame them, and its difficult to tell its been planted. Each of us disposes of our DNA everywhere we go.
Its a lot harder to fabricate DNA to match a specific person, and such fabrications are easy to detect. And when you detect it, you immediately know someone with a lot of money and skill is involved.
No, you are mistaken. I've always had this sig.
(Score: 2) by takyon on Friday October 23 2015, @10:28PM
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.
[SIG] 10/28/2017: Soylent Upgrade v14 [soylentnews.org]
(Score: 2) by frojack on Saturday October 24 2015, @03:55AM
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.
No, you are mistaken. I've always had this sig.