Tag Archives: genetic

FDA orders 23andMe to stop selling DNA-testing kits pending approval

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For more than five years, 23andMe has sent out personalized DNA test kits, offering consumers hundreds of clinical reports on their genetic risk for everything from diabetes to prostate cancer. Its mission to educate customers about their health and ancestry appears to have been dealt a blow, however, after the US Food and Drug Administration (FDA) said the company needs its approval. It's told 23andMe to stop advertising its DNA-testing product until it gets the medical device classification it needs, which involves conducting studies of the kits to gain documented proof of their accuracy.

The agency is also worried that customers might take action, or not, based on test results that may or may not be correct. 23andMe has attempted to gain clearance in the past, but hasn't done everything it needs to get the green light. Make no mistake, a run-in with the FDA is not to be taken lightly: satisfying the agency's requirements is going to be a long and expensive process. 23andMe now has to tell the agency exactly how it intends to gain marketing authorization for the device, or it could face regulatory action (which includes injunctions, seizures and hefty fines).

Update: 23andMe has issued a statement on the matter:

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.

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Via: Bloomberg

Source: FDA

Goats Genetically Modified to Produce Human Breast Milk

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There’s a reason why doctors recommend that mothers breastfeed their newborns for the first few weeks of their lives: because human breastmilk provides the infant with much-need immune system boosters.

But if for some reason the new mothers can’t breastfeed their child, there’s a new alternative: goat’s milk. Or rather, the milk of dairy goats that have been genetically modified to contain lactoferrin, which is the protein found in human milk that arms newborns with immune protection. This component also fights off fungi and bacteria and also helps strengthen the child’s immune system.

Dairy Goats Milk
Goat’s milk is easily contaminated though, so obviously the farm and where the milking will take place should be thoroughly cleaned and sanitary.

I think this is an interesting development and could benefit millions of babies all over the world. I just wonder if there are any possible negative effects that can arise from consuming genetically modified goat’s milk. It is genetically modified, after all. And while we’re not talking about cloning or stuff like it, who knows what could go wrong if you try to tweak what nature has already provided?

[via Softpedia]


Max Planck Institute sequences genome of Siberian girl from 80,000 years ago, smashes DNA barriers

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Max Planck Institute sequences genome of Siberian girl from 80,000 years ago, smashes DNA barriers

We've known little of the genetic sequences of our precursors, despite having found many examples of their remains: the requirement for two strands in traditional DNA sequencing isn't much help when we're usually thankful to get just one. The Max Planck Institute has devised a new, single-strand technique that may very well fill in the complete picture. Binding specific molecules to a strand, so enzymes can copy the sequence, has let researchers make at least one pass over 99.9 percent of the genome of a Siberian girl from roughly 80,000 years ago -- giving science the most complete genetic picture of any human ancestor to date, all from the one bone you see above. The gene map tells us that the brown-skinned, brown-eyed, brown-haired girl was part of a splinter population known as the Denisovans that sat in between Neanderthals and ourselves, having forked the family tree hundreds of thousands of years before today. It also shows that there's a small trace of Denisovans and their Neanderthal roots in modern East Asia, which we would never have known just by staring at fossils. Future discoveries could take years to leave an impact, but MPI may have just opened the floodgates of knowledge for our collective history.

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Max Planck Institute sequences genome of Siberian girl from 80,000 years ago, smashes DNA barriers originally appeared on Engadget on Mon, 03 Sep 2012 01:42:00 EDT. Please see our terms for use of feeds.

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Harvard stores 704TB in a gram of DNA, may have us shopping for organically-grown storage (video)

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Harvard stores 704TB in a gram of DNA, may have us shopping for organicallygrown storage video

Early research has had DNA making circuits and little factories. We haven't really seen DNA used as a storage medium, however, and it's evident we've been missing out. A Harvard team led by George Church, Sriram Kosuri and Yuan Gao can stuff 96 bits into a DNA strand by treating each base (A, C, G, T) as though it's a binary value. The genetic sequence is then synthesized by a microfluidic chip that matches up that sequence with its position in a relevant data set, even when all the DNA strands are out of order. The technique doesn't sound like much on its own, but the microscopic size amounts to a gigantic amount of information at a scale we can see: about 704TB of data fits into a cubic millimeter, or more than you'd get out of a few hundred hard drives. Caveats? The processing time is currently too slow for time-sensitive content, and cells with living DNA would destroy the strands too quickly to make them viable for anything more than just transfers. All the same, such density and a lifespan of eons could have us turning to DNA storage not just for personal backups, but for backing up humanity's collective knowledge. We're less ambitious -- we'd most like to know if we'll be buying organic hard drives alongside the fair trade coffee and locally-sourced fruit.

Continue reading Harvard stores 704TB in a gram of DNA, may have us shopping for organically-grown storage (video)

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Harvard stores 704TB in a gram of DNA, may have us shopping for organically-grown storage (video) originally appeared on Engadget on Sun, 19 Aug 2012 01:06:00 EDT. Please see our terms for use of feeds.

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Amazon stores 1,700 human genomes in the cloud

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Amazon stores 1,700 human genomes in the cloudNot content with speeding up web browsing and hosting federal data, Amazon Web Services are now helping in the fight against disease. Bezos' crew is donating a chunk of free cloud storage to the 1000 Genomes project, which aims to make it easier for scientists to search for genetic variations linked to diseases. These gene-hunters can also use Amazon's Elastic Cloud Compute service to analyze data and discover patterns, although those functions won't come gratis. The DNA sequences of 1,700 mostly anonymous Homo sapiens from around the world have already been logged, but the project has to upload another 1,000 samples before it meets statistical requirements. If it ever needs fresh volunteers, perhaps a free USB gene sequencer and a Prime subscription might do the trick?

Amazon stores 1,700 human genomes in the cloud originally appeared on Engadget on Sat, 31 Mar 2012 09:07:00 EDT. Please see our terms for use of feeds.

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