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23andMe on path to FDA approval

Posted: Published on June 22nd, 2014

Genetics start-up 23andMe said on Friday it is one step closer to resuming sales of its full-fledged health product, with the U.S. Food and Drug Administration accepting its first health report for review. The home genetics company said in a blog post that the FDA will begin evaluating the company's submission for a 510(k) application, a regulatory process that applies to most medical devices sold in the United States. Kathy Hibbs, 23andMe's chief legal and regulatory officer, said in the blog post that the submission focused on one single inherited condition, called Bloom Syndrome. "Once cleared, it will help 23andMe, and the FDA, establish the parameters for future submissions,'' Hibbs writes. Read More 3 promising tech darlings that fell flat In November of 2013, the Google-backed firm stopped selling its $99 DNA test until it obtained marketing authorization from the FDA. 23andMe had previously said in its marketing materials that it could deliver insights about people's genetic predispositions toward "254 diseases and conditions.'' But in a public warning letter last November, addressed to 23andMe's chief executive Anne Wojcicki, the FDA expressed concerns about the "public health consequences of inaccurate results'' from 23andMe's genetic test kit. Bradley Merrill Thompson, a product … Continue reading

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May 2014 Breaking News Mixing Human DNA with Animal DNA Last days final hour news prophecy – Video

Posted: Published on June 22nd, 2014

May 2014 Breaking News Mixing Human DNA with Animal DNA Last days final hour news prophecy May 2014 Breaking News Mixing Human DNA with Animal DNA - Last Days End Times News Prophecy Update - Genetic Engineering. By: nilay … Continue reading

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Movie Fun Run ICGEB 2014 – Video

Posted: Published on June 22nd, 2014

Movie Fun Run ICGEB 2014 By: International Centre for Genetic Engineering and Biotechnology … Continue reading

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DEINOVE at the Cutting Edge of Strain Construction Technologies

Posted: Published on June 22nd, 2014

This software speeds up and streamlines the assembly of genetic building blocks that are of interest before transferring them to a host strain. It reduces human interventions and standardizes them, providing a cloning plan that can then be executed by a high-speed robot. This genetic engineering operation is used to optimize a strains genome so that it will efficiently produce various molecules of industrial interest. CAD4Bio software can also be interfaced with Genostar Pathway Browser software, which gathers all DEINOVEs genomic and transcriptomic data (genetic building blocks). These genetic building blocks may be DNA sequences, genes coding for a key enzyme, or regulatory elements (promoters, attenuators, etc.). They are used to add, remove or modulate the functions of Deinococcus bacteria, whose complete genome is known. Depending on the function that will be assigned to the host strain, these building blocks are selected and imported into the CAD4Bio software which helps the DEINOVE researchers to design the host strains genome, integrating the key genes. The software then calculates the sequences needed to amplify the building blocks and assemble them. This operating procedure, which give rise to a detailed cloning plan, are sent to the robot for execution. The robot in the … Continue reading

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GM: from the field to the lab

Posted: Published on June 22nd, 2014

Welcome to GM in Australia, a The Conversation series looking at the facts, ethics, regulations and research into genetically modified (GM) crops. In this first instalment, Peter Langridge describes two GM techniques: selective breeding and genetic engineering. GENETIC modification (GM) sounds very laboratory-based people in white coats inserting and deleting genes but the vast majority of GM work was completed in the field through selective breeding. Early Middle Eastern farmers collected grain from natural grasslands, but they needed to time their harvest very carefully. If they were too early the grain wouldnt store well, and if they were too late the grain would spread over the ground making collection difficult. At some stage, one of these early farmers must have noticed that some heads remained fixed on their stems even after the grain was fully dry. He obviously didnt understand this at the time, but these were plants with a mutation in the genes controlling seed dispersal. Farmers began preferentially choosing plants with this useful mutation and planting them, perhaps the first case of breeding and selecting for a novel trait. Gregor Mendel. Wikimedia, CC BY Systematic breeding really began in the early 1900s when scientists rediscovered Silesian monk Gregor … Continue reading

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Introducing synthetic features to living organisms without genetic modification

Posted: Published on June 22nd, 2014

Jun 16, 2014 by Lisa Zyga (a) In the absence of artificial cells (circles), E. coli (oblong) cannot sense theophylline. (b) Artificial cells can be engineered to detect theophylline and in response release IPTG, a chemical signal that induces a response in E. coli. Credit: (c) 2014 Nature (Phys.org) Genetic engineering is one of the great achievements of modern science, allowing for the insertion or deletion of genes in order to control an organism's characteristics and behaviors. However, genetic engineering has its drawbacks, including the difficulties involved in engineering living systems and the potential long-term consequences of altering ecosystems with engineered organisms. But a new study has shown that controlling organisms on the cellular level does not necessarily require genetic modification. Writing in Nature Communications, Roberta Lentini, et al., have demonstrated that Escherichia coli (E. coli) behavior can be controlled by constructing artificial cells that first sense molecules that E. coli alone cannot sense, and then release different molecules that E. coli can sense. In a way, the artificial cells act as translators by converting unrecognized signals into a chemical language that organisms can understand. The translated signal can then potentially trigger a controllable response in the organism. "In my … Continue reading

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Gene Therapy for Beta Thalassemia – Video

Posted: Published on June 22nd, 2014

Gene Therapy for Beta Thalassemia By: bluebird bio … Continue reading

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Isis Could Get a $2 Billion Gain From Heart Attack Trials

Posted: Published on June 22nd, 2014

Isis Pharmaceuticals Inc. (ISIS), a maker of gene therapy treatments, may seek to expand use of an experimental drug targeting triglycerides to fight heart disease, a move an analyst says could add $2 billion in sales. The drug targets the APOC3 gene and is now aimed solely at a rare disease thats linked to diabetes and pancreatitis and affects about 5,000 people. Two studies this week, however, have also tied the gene to lower risk of heart disease, an illness that kills 600,000 people yearly, a much larger target. The research, done independently of Isis, was highlighted in the New England Journal of Medicine. It may open a new window of opportunity for Isis once the drug, called ISIS-APOCIIIRx and heading to final testing, is approved and may spark interest from potential acquirers, analysts said. Were weighing how we want to take full advantage of this breakthrough, and as we do that we have to consider the potential broader development of the follow on product, Isis Chief Executive Officer Stanley Crooke said by telephone. We have a great deal of licensing interest for this drug. In the New England Journal of Medicine studies, mutations in the APOC3 gene decreased the … Continue reading

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Science Project: Body Structures, Vestigial Organs, Embryology, and Descent with Modification – Video

Posted: Published on June 22nd, 2014

Science Project: Body Structures, Vestigial Organs, Embryology, and Descent with Modification My Science Project. By: Jon Mak … Continue reading

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9th Cyprus Salsa Congress – DNA – Video

Posted: Published on June 22nd, 2014

9th Cyprus Salsa Congress - DNA By: SalsaCyprus Christos Shakallis … Continue reading

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