FDA Eases Access to DNA Screening for Inherited Diseases

Matthew Perrone, Yahoo! News, February 19, 2015

Federal health officials are easing access to DNA tests used to screen parents for devastating genetic disorders that can be passed on to their children. The surprise announcement offers a path forward for Google-backed genetic testing firm 23andMe, which previously clashed with regulators over its direct-to-consumer technology.

The Food and Drug Administration said late Thursday it will not require preliminary review before companies can sell so-called carrier screening tests to the public. The tests, currently administered by health care professionals, are used by prospective parents who are healthy but may be carriers of cystic fibrosis, Tay-Sachs and other rare familial conditions.

In the same announcement, the FDA said it cleared the first carrier screening test from 23andMe, which was forced to pull its health tests from the market in 2013 due to a lack of scientific evidence.

23andMe’s test screens for the genetic mutations that cause Bloom syndrome, a rare disorder that causes short stature, increased risk of cancer and a variety of other health problems. The disorder is more common in people of central and eastern European Jewish descent, affecting about 1 in 50,000.

The positive FDA decision is a victory for Mountain View, California-based 23andMe, which had recently become something of a poster child for the culture clash between Silicon Valley and Washington.

The company’s CEO Anne Wojcicki said in an interview that her company’s research demonstrates that patients can understand genetic testing results.

“Our user comprehension studies have shown that people can get this information on their own without a physician and that there’s potentially a real benefit to direct access,” said Wojcicki.

Bloom syndrome is one of about 250 conditions and diseases that 23andMe’s original DNA kit claimed to help screen for by analyzing users’ genetic code. Wojcicki says that her company has another 45 to 50 carrier screening tests that could return to the market under the FDA ruling, possibly later this year.

{snip}

In November 2013, the FDA ordered 23andMe to stop selling its health tests. FDA said that despite over a dozen meetings and “hundreds of email exchanges” the company had failed to show the tests were backed by science. Regulators also took issue with a number of claims used to market the technology, particularly calling it a “first step in prevention” against diseases like diabetes, heart disease and breast cancer.

23andMe continues to sell genetic ancestral information and raw, unprocessed DNA data through its basic kit, which costs $99.

{snip}

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  • Luca

    Saving lives through DNA testing doesn’t matter. These tests may one day prove that IQ is largely inherited along racial groups. Imagine the convulsions the liberal mafia would go through if that ever happened.

    • TomIron361

      Imagine the convulsions the liberal mafia would go through if that ever happened.
      __________________________________________________________
      No sweat, the public is so enstupidated now they wouldn’t even notice.

      • John Smith

        “Idiocracy” could be a documentary….

        • I think that was Mike Judge’s intent. It’s just that it went over most people’s heads, the relatively few that watched it.

          • John Smith

            It must’ve been uncomfortable for them.

        • WhiteGuyInJapan

          That movie was too optimistic. I doubt it will take 500 years to get to that point. The Retard Revolution is already is in full swing.

          • John Smith

            We do already have a black POTUS, so they got that part right. They’re the experts in stupidity and destroying infrastructure.

    • JohnEngelman

      It will happen, probably in our life times.

    • dd121

      It’s already known. The liberals simply deny what isn’t convenient to their ideology.

    • listenupbub

      Yes, and they have already shown that gayness is not genetic. Oops. The liberals were not expecting that one.

      • TheMaskedUnit

        That still doesn’t stop the faithful from believing that heterosexuality is not evolutionarily advantageous over anal mounting.

  • LHathaway

    Some test are more obvious. Potential mothers are already screening for obvious signs of Whiteness.

  • MekongDelta69

    I have a ‘devastating genetic disorder.’ I post on AmRen too much!

    Gosh Beav – I hope I can put my trust in the ‘noble’ government-run FDA to cure me. I mean, it’s not as if they would do anything nefarious to me.

    Would they?!?

    • I hope you get out and post in the ‘real world’ too. While I’m all in favor of solidarity, preaching here to the converted accomplishes relatively little.

      • John Smith

        It gives people confidence they aren’t alone, which is a myth the MSM is cultivating.

      • Realist

        “I hope you get out and post in the ‘real world’ too. While I’m all in favor of solidarity, preaching here to the converted accomplishes relatively little.”

        Same for preaching to idiots.

  • dd121

    This puts us in the most dangerous position of having to trust the government and hope they don’t have an agenda that excludes you.

    • LHathaway

      If you’re a white man, and you don’t know they have an agenda to exclude you already . . . .

      • dd121

        Exactly, I don’t think the government will do anything that I think is right.

  • E_Pluribus_Pluribus

    Having recently completed a Great Courses course on genetics, “Understanding Genetics: DNA, Genes, and Their Real-World Applications,” by cancer researcher Professor David Sadava Ph.D., three points:

    1) I recommend this 24-lecture (30 min/lecture) very intensive course. I read the guidelines for each lecture, watch the lecture, then read the transcript. Watch again at a later point. The subject matter is quite complex. Anyone who wants a foundation in this field would be hard pressed to top this.

    2) Applications of genetics research are, in my estimation, where applications of the digital revolution were in the late 1970s. That is, the field is about to take off.

    3) I submitted my DNA to 23andme a couple of weeks ago and await results on ancestry and, down the line, when FDA clearance is approved, with health. The “carrier” question is a matter of curiosity but of no consequence. At an age when procreation is not on the horizon, knowing that I am a “carrier” of various conditions that I do not myself have is of not much use. But this information could be of immense importance to a young couple contemplating marriage and procreation.

  • Wing-nut.

    Not gonna let a Google owned company have my DNA.

    • John Smith

      At least not under my real name.

  • TL2014

    Why only for african ancestry?

    • a multiracial lndividual

      1. I am partially African American

      2. We have suffered the most.

      • gemjunior

        You have made others suffer the most so we are even.

      • BlueSonicStreak

        2. I personally would support catching up Africa – it’s to the benefit of us all. That’s a practical reason, not because of your “suffering.” The entire world suffers your very existence, given your insane crime rates. And the fact that you have not kept up with the rest of us in civilization-building is not our fault either, despite your endless attempts to blame us for it. You were behind before any other race ever clapped eyes on you.

      • mikey7777

        rothflmfao! you cannot actually believe what you just posted,can you.

  • E_Pluribus_Pluribus

    Racial preferences for access to gene therapy and embryo selection technology. Interesting concept. Once the Left finally admits genetic differences in IQ, personality, etc by race, I expect it will eagerly embrace exclusive access to biotechnology for protected minorities. Leftist billionaires might indeed get affirmative action gene therapy rolling.

    I do have sympathy for groups that have been dealt a bad hand genetically, but the idea of denying technologies whites invented to whites is rather appalling.

    • Germanicus

      I am also concerned about to unforeseen consequences. Today: “A new freedom is granted to you!” Tomorrow: “The new freedom is popular, the market demands broad acceptance–of course you may pay a premium to opt out.” The day after: “The new freedom is a requirement, under penalty of law.” We Whites are good at inventing things to our own detriment.

  • Interested Party

    ” Currently only 28% of Americans approve of genetic enhancements (for intelligence). When it becomes painfully obvious that individuals that were selected dominate fields such as: medicine, science, law, engineering, etc. More and more people will figure out that they simply cannot afford to not enhance their children.”
    It won’t matter. Normal curve theory holds that there will always be an average, below average and above average and so on. If everyone were given a smart pill right now and made smarter, some of those people would be average smart or above average smart or below average smart and so on. Thus, nothing would change in terms of comparison to others.

  • What about a test for inherited stupidity? I know of a fairly reliable visual test that requires no DNA work.

    • Bossman

      Sometimes stupid people can become smarter when they receive a blow to the head.

      • Reynardine

        I’m sorry, but no matter how many times your dad shook you or your mother dropped you on your head, it’s not going to make you smarter.

  • Michelle

    I had my DNA tested a few months ago through 23andme. I gave a coworker/friend a test for Xmas. Since then I have been exploring on gedmatch and 23andme, both of our ancestry’s. He, totally unknown to him, turned out to be a third Ashkenazi Jewish. I, totally unknown to me, turned out to be part Finnish. His DNA relatives are Hollywood writers and actors, lawyers, doctors and politicians. Mine are, astrophysicists, geophysicists, pharmacists, pharmaceutical packaging designers, and UN translators, liaisons for the Iranian to Russian and India to Russian gas and energy industries, and safety workers (high angle rope and small space rescue team experts) for Texas based gas and energy industries, and medical scientific researchers. I have strong interests in medicine, languages, and astronomy. My friend loves movies and movie making. Finnish immigrants to America had a 98% literacy rate. I started reading at age 3. Blood will tell!

  • Groovy

    Didn’t Wojcicki recently host a big fund raiser for Obama. She was married to Sergi Brin.

  • BlueSonicStreak

    Yes, I think the world would be a fantastic place then. Imagine Africa was as advanced as the West, and the whole world was equally industrious and driven. We’d go to Mars! It’s not solely to the benefit of blacks, as that would enhance everyone’s interests. So I agree with your last sentence.

    But you did lay claim to “suffering the most,” and to suggesting then that other groups deserve to be held back to let you catch up. There’s an obvious implication of revenge or atonement there that I hope you can see.

    Fact is, blacks have suffered nothing in interracial conflict that other groups haven’t. Anything extra on top of that is solely the result of black nature. That’s unfortunate (and certainly one more reason to consider biological intervention to advance you), but it is no one else’s fault, and nobody else should be handicapped just to try to catch you up. We’ve already been doing that socially for decades, and it was a disaster.