FDA LDT meeting, bigger than just DTCG!

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At the FDA public hearing today, I began to hear a collective groan. The groan was from the LDT community that provide tests that are actually in clinical use today. You, see, this hearing is much more about LDT than it is about little 'Ol DTCG.

DTCG in fact was the perp walk that allowed LDT to now fall under question. For years, Home Brew labs up at Yale and Harvard and GeneDx and I could go on and on, went unscathed from FDA regs. Why? The tests were used by so few people and the case for harm was pretty weak.

Despite all of this, the FDA is now awoken and realizing it was asleep at the wheel here while the wagon train was being run by the Music Man! You can tell from the agenda that there is one thing at stake here........the future of nearly ALL genetic testing.

If you look at the list of speakers it was a hodgepodge of diagnostic labs, testing advocacy groups, consulting firms that bring biopharma through the pipeline and something called OMBU. WTF is OMBU?

Tomorrow is more of the same. Of course Wadsworth was there to represent some sanity in this process, thank god. But my big Gestalt from today's action is:

1. The FDA firnly believes it is time to get its act together in regulating genetic testing

3. The FDA regulates tests, not labs.

What does this mean.

Well I can tell you this. The FDA will regulate LDT and follow some line that it already has with things like AmpliChip.

I can also tell you, the LDT house is huge and a few little revolutionaries in DTCG have brought the entire house down. I am surprised that the genetic testing industry and academic labs didn't see this one coming. So many I know in the space were always pro DTCG, I warned them precisely against the regulatory scrutiny which LDT would face given "Oprah, Dr. Oz, Blimps, Open Bars and Trump"

They said, nawh, we are ok in this space and serve a need, why regulate us? I think in Genetech we just found the answer. How can we hold a corporation to a different standard than an academic lab? How can we hold a big company to a different standard from a small company? How can we justify that to the public? More importantly, to the court?

The answer: They can't.

The Sherpa Says: I don't think I could stand another moment of the FDA conference tomorrow. Instead I will play on loop C3PO saying "Please don't deactivate me"

Stephen Schneider, Leading Climatologist, is Dead at 65 | The Intersection

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StephenSchneider-byAnnePolanskyI am stunned, because he seemed so alive and vibrant when I saw him in December 09 in Copenhagen, and in Feb 2010 at the AAAS meeting in San Diego. But Stephen Schneider, one of the greats of climate science–and climate policy, and public outreach–died today of an apparent heart attack.

There are tributes from the WWF blog, DotEarth, HuffPost, and many more. Let me quote Andy Revkin:

I first interviewed Schneider in the early 1980s while trying to make sense of the  percolating notion of nuclear winter, which Schneider — always following the data — ended up determining would more likely be a “nuclear autumn.” It was his caustic honesty about the complex nature of global warming, and the inherent uncertainties in the science, that kept mereturning to him for input from 1988 onward. He was a participant in the assessments of the Intergovernmental Panel on Climate Change from the beginning until the last days of his life. He encouraged scientists to get out and communicate directly with the public, maintaining a Web page, “Mediarology,” describing the challenges attending such a move.

Ralph Cicerone, president of the National Academy of Sciences, says:

His biggest goal in life was to see a rational approach to policy about climate change, where he tried to evaluate the odds and show people, just like in many other decisions in life, with climate they had to play the odds. He was trying to produce probabilistic ways to make evaluations that could work. In his lifetime, his approach on this became progressively more sophisticated.

Peter Gleick says:

His clear and comprehensive explanations of climate change, his encyclopedic knowledge of how the climate works, and his challenges to the fraudulent science that characterizes the arguments of the climate deniers, made it easier for politicians to understand the true climate threats that face us and to move the debate into the public arena. That debate continues, because the science and policy challenges are complicated, but the world is at least beginning to take key steps toward preventing a climate catastrophe because Stephen Schneider knew that the alternative was unacceptable and because he worked tirelessly to move us all in the right direction.

He will be missed….


Transmitter/Receiver

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I want to build a circuit that can transmit and receive signals to turn on a light source. The distance is about 80feet. Whats the best way to go about this, circuit diagrams and all I will need to start and complete this project. Thanks

Trunnion Support Modelling

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Hi all,

In modelling trunnion/dummy support in CAESAR II, what particular type of connection we consider between the two connection?

It is okey to consider a tee connection & put SIF by activating the SIF and TEE checkbox and consider the "unreinforced" type connection and put SIF valu

Big News for NASA Nebula

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NASA's Nebula Cloud Computing Technology To Play Key Role In New Open Source Initiative

"The core technology developed for NASA's Nebula cloud computing platform has been selected as a contributor for OpenStack, a newly-launched open source cloud computing initiative. It will pull together more than 25 companies to play a key role in driving cloud computing standards for interoperability and portability."

Rackspace and NASA open-source partnership could spur innovation, GCN

"Torlini acknowledged the concerns that many users have about security in the cloud. However, he said freeing up the code would present more opportunities to improve security. He also stressed that this shouldn't be seen as purely a Rackspace initiative, "Everyone is welcome to contribute," he said."

NASA and Rackspace part the clouds with open source project, ARS Technica

"Modern scientific computation requires ever increasing storage and processing power delivered on demand," said NASA CTO Chris Kemp in a statement. "To serve this demand, we built Nebula, an infrastructure cloud platform designed to meet the needs of our scientific and engineering community. NASA and Rackspace are uniquely positioned to drive this initiative based on our experience in building large scale cloud platforms and our desire to embrace open source."

NASA gives OpenStack instant credibility, ZDNet

"The new OpenStack project will power NASA's own Nebula cloud and puts new pressure on Eucalyptus, as well as Amazon's EC2 and the whole Hadoop ecosystem. The system is being released under an Apache 2 license."

NCBI ROFL: Speedos: not just for streamlining your junk. | Discoblog

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swimmingProposal of alternative mechanism responsible for the function of high-speed swimsuits.

“Since many top swimmers wearing Speedo LZR Racer swimsuits have broken world records, it is considered that the corset-like grip of suit supports the swimmers to maintain flexibility of movement and reducing water resistance. We propose an alternative mechanism to explain this phenomenon. The suits are so tight that the blood circulation of swimmers is suppressed.This effect accelerates the anaerobic glycolysis system but rather suppresses the aerobic mitochondrial respiration system. Because of the prompt production of ATP in the glycolysis system, the swimmers, especially in short distance competitions, obtain instantaneous force in white fibers of the skeletal muscles.”

speedo

Photo: flickr/marcopako ?

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Discoblog: NCBI ROFL: Oh, snap! You got burned!

WTF is NCBI ROFL? Read our FAQ!


Transformer Load

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Hi ,

Let' s say I have an elevator 1000KVA(primary 400volts and secondary 15KV)transformer and would like it to feed others transformers on MV(15KV) level. I am planning to feed on 15KV level 5 others transformers, would it work? In another words, how many transformers can I feed with this

Genome-wide association for newbies | Gene Expression

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It looks like Genomes Unzipped has their own Mortimer Adler, with an excellent posting, How to read a genome-wide association study. For those outside the biz I suspect that #4, replication, is going to be the easiest. In the early 2000s a biologist who’d been in the business for a while cautioned about reading too much into early association results which were sexy, as the same had occurred when linkage studies were all the vogue, but replication was not to be. Goes to show that history of science can be useful on a very pragmatic level. It can give you a sense of perspective on the evanescent impact of some techniques over the long run.