Category Archives: Human Genetic Engineering

References

1. F.T. Moutos et al., Anatomically shaped tissue-engineered cartilage with tunable and inducible anticytokine delivery for biological joint resurfacing, Proc. Natl. Acad. Sci. U.S.A. 113 (31) E4513E4522, doi: 10.1073/pnas.1601639113.

2. B. Zhang et al., Biodegradable scaffold with built-in vasculature for organ-on-a-chip engineering and direct surgical anastomosis, Nat. Materials 15, 669678 (2016), doi:10.1038/nmat4570.

3. S. Shukla et al., Progenitor T-cell differentiation from hematopoietic stem cells using Delta-like-4 and VCAM-1, Nat. Methods 14(5), 531-538 (May 2017),doi: 10.1038/nmeth.4258. Epub Apr 10, 2017.

4. M.M. Pakulska, S. Miersch, and M.S. Shoichet, Designer protein delivery: from natural occurring to engineered affinity controlled release systems, Science 351(6279):aac4750, doi: 10.1126/science.aac4750.

5. M.M. Pakulska, C.H. Tator, and M.S. Shoichet, Local delivery of chondroitinase ABC with or without stromal cell-derived factor 1 promotes functional repair in the injured rat spinal cord, Biomaterials (accepted April 2017).

6. TissueGene, TissueGene to Highlight Invossa, the Worlds First Cell-Mediated Gene Therapy for Degenerative Osteoarthritis, at JP Morgan Healthcare Conference, Press Release,accessed June 12, 2017.

7. O.J.L. Rackham et al., A predictive computational framework for direct reprogramming between human cell types, Nat. Genetics 48, 331335 (2016), doi:10.1038/ng.3487.

8. D.B. Kolesky et al., Three-dimensional bioprinting of thick vascularized tissue, Proc. Natl. Acad. Sci. U.S.A. 113 (12), 31793184, doi: 10.1073/pnas.1521342113.

9. M.M. Laronda et al., A Bioprosthetic Ovary Created Using 3D Printed Microporous Scaffolds Restores Ovarian Function in Sterilized Mice, Nat. Commun. 8, 15261 (May 16, 2017).

10. I. Sagi et al., Derivation and differentiation of haploid human embryonic stem cells, Nature 532, 107111 (April 7, 2016), doi:10.1038/nature17408.

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GEN Roundup: Top Trends in Tissue Engineering - Genetic Engineering & Biotechnology News

Last month, researchers announced some astonishing findings in Nature Genetics: Theyd found 40 genes that play a role in shaping human intelligence, bringing the total number of known intelligence genes up to 52.

This study was a big deal because while weve known intelligence is largely heritable, we havent understood the specifics of the biology of IQ why it can be so different between people, and why we can lose it near the end of life.

The Nature Genetics study was a key early step toward understanding this, hailed as an enormous success in the New York Times.

And there are many more insights like this to come. The researchers used a design called a genome-wide association study. In it, computers comb through enormous data sets of human genomes to find variations among them that point to disease or traits like intelligence. As more people have their genomes sequenced, and as computers become more sophisticated at seeking out patterns in data, these types of studies will proliferate.

But theres also a deep uneasiness at the heart of this research it is easily misused by people who want to make claims about racial superiority and differences between groups. Such concerns prompted Nature to run an editorial stressing that the new science of genetics and intelligence comes to no such conclusions. Environment is crucial, too, Nature emphasized. The existence of genes for intelligence would not imply that education is wasted on people without those genes. Geneticists burned down that straw man long ago.

Also, nothing in this work suggests there are genetic difference in intelligence when comparing people of different ancestries. If anything, it suggests that the genetics that give rise to IQ are more subtle and intricate than we can ever really understand.

Were going to keep getting better at mapping the genes that make us smart, make us sick, or even make us lose our hair. But old fears and myths about genetics and determinism will rear their heads. So will fears about mapping ideal human genes that will lead to designer babies, where parents can pick traits for their children la carte.

To walk through the science, and to bust its myths, I spoke to Danielle Posthuma, a statistical geneticist at Vrije Universiteit in Amsterdam, who was the senior author on the latest Nature study.

Theres a simple understanding of genetics were all taught in high school. We learn, as Gregor Mendel discovered with pea plants, that we can inherit multiple forms of the same gene. One variation of the gene makes wrinkled peas; the other makes for round peas. Its true, but its hardly the whole story.

In humans, a few traits and illnesses work like this. Whether the bottom of your earlobes stick to the side of your face or hang free is the result of one gene. Huntingtons disease which deteriorates nerve cells in the brain is the result of a single gene.

But most of the traits that make you you your height, your personality, your intellect arise out of a complex constellation of genes. There might be 1,000 genes that influence intelligence, for example. Same goes for the genes that lead to certain disorders. Theres no one gene for schizophrenia, for obesity, for depression.

A single gene for one of these things also wont have an appreciable impact on behavior. If you have the bad variant of one gene for IQ, maybe your IQ score ... is 0.001 percent lower than it would have been, Posthuma says.

But if you have 100 bad variants, or 1,000, then that might make a meaningful difference.

Genome-wide association studies allow scientists to start to see how combinations of many, many genes interact in complicated ways. And it takes huge data sets to sort through all the genetic noise and find variants that truly make a difference on traits like intelligence.

The researchers had one: the UK Biobank, a library that contains genetic, health, and behavioral information on 500,000 Britons. For the study, they pulled complete genome information on 78,000 individuals who had also undergone intelligence testing. Then a computer program combed through millions of sites on the gene code where people tend to variate from one another, and singled out the areas that correlated with smarts.

The computer processing power needed for this kind of research this study had to crunch 9.3 million DNA letters from 78,000 people hasnt been available very long. But now that it is, researchers have been starting to piece together the puzzle that links genes to behaviors.

A recent genome-wide analysis effort identified 250 gene sites that predicted male pattern baldness in a sample of 52,000 men. (Would you really want to know if you had them?) And theres been progress identifying genes that signal risk for diabetes, schizophrenia, and depression.

And these studies dont just look at traits, diseases, and behavior. Theyre also starting to analyze genetic associations to life outcomes. A 2016 paper in Nature reported on 74 gene sites that correlate with educational attainment. (These genes, the study authors note, seem to have something to do with the formation of neurons.) Again, these associations are tiny the study found that these 74 gene variants could only explain 3 percent of the difference between any two people on what level of education they achieve. Its hardly set in stone that youll flunk school if you dont have these gene variants.

But still, they make a small significant difference once you start looking at huge numbers of people.

Its important to note that Posthumas study was only on people of European ancestry. Whatever we find for Europeans doesnt necessarily [extrapolate] for Asians or South Americans, [or any other group] she says. Those things are often misused.

Which is to say: The gene variations that produce the differences between Europeans arent necessarily the same variations that produce differences among groups of different ancestry. So if you were to test the DNA of someone of African origin, and saw they lacked these genes, it would be incredibly irresponsible to conclude they had a lower capacity for intelligence. (Again, there are also likely hundreds of more genetic sites that have something to do with intellect that have yet to be discovered.)

Posthumas work identifying genes associated with intelligence isnt about making predictions about how smart a baby might grow up to be. She doesnt think you can reliably predict educational or intelligence outcomes from DNA alone. This is all really about reverse-engineering the biology of intelligence.

Genes code for proteins. Proteins then interact with other proteins. Researchers can trace this pathway all the way up to the level of behavior. And somewhere along that path, there just might be a place where we can intervene and stop age-related cognitive decline, for instance, and Alzheimers.

We're finally starting to see robust reliable associations from genes with their behavior, she says. The next step is how do we prove that this gene is actually evolved in a disorder, and how does it work?

Understanding the biology of intelligence could also lead the way for personalized approaches to treating neurodegenerative diseases. Its possible that two people with Alzheimers may have different underlying genetic causes. Knowing which genes are causing the disease, then, you might be able to tailor the treatment, Posthuma says.

As more and more genome-wide studies are conducted, the more researchers will be able to assign people polygenic risk scores for how susceptible they might be for certain traits and diseases. That can lead to early interventions. (Or, perhaps in the wrong hands, a cruel and unfair sorting of society. Have you seen the movie Gattaca?)

And there are some worries about abusing this data, especially as more and more people get their genomes analyzed by commercial companies like 23&Me.

Many people are concerned that insurance companies will use it, she says. That they will look into people's DNA and say, Well, you have a very high risk of being a nicotine addict. So we want you to pay more. Or, You have a high risk of dying early from cancer. So you have to pay more early in life. And of course, that's all nonsense. Its still too complicated to make such precise predictions.

We now have powerful tools to edit genes. CRISPR/Cas9 makes it possible to cut out any specific gene and replace it with another. Genetic engineering has advanced to the point where scientists are building whole organisms from the ground up with custom DNA.

Its easy to indulge our imaginations here: Genome-wide studies are going to make it easier to predict what set of genes leads to certain life outcomes. Genetic engineering is making it easier to assemble whatever genes we want in an individual. Is this the perfect recipe for designer babies?

Posthuma urges caution here, and says this conclusion is far afield from the actual state of the research.

Lets say you wanted to design a human with superior intelligence. Could you just select the right variants of the 52 intelligence genes, and wham-o, we have our next Einstein?

No. Genetics is so, so much more complicated than that.

For one, there could be thousands of genes that influence intelligence that have yet to be discovered. And they interact with each other in unpredictable ways. A gene that increases your smarts could also increase your risk for schizophrenia. Or change some other trait slightly. There are trade-offs and feedback loops everywhere you look in the genome.

If you would have to start constructing a human being from scratch, and you would have to build in all these little effects, I think we wouldn't be able to do that, Posthuma says. It's very difficult to understand the dynamics.

There are about 20,000 human genes, made up of around 3 billion base pairs. We will never be able to fully predict how a person will turn out based on the DNA, she says. Its just too intricate, too complicated, and also influenced heavily by our environment.

So you could have a very high liability for depression, but it will only happen if you go through a divorce, she says. And who can predict that?

And, Posthuma cautions, there are some things that genome-wide studies cant do. They cant, for instance, find very, very rare gene variations. (Think about it: If one person in 50,000 has a gene that causes a disease, its just going to look like noise.) For schizophrenia, she says, we know that there's some [gene] variants that decrease or increase your risk of schizophrenia 20-fold, but they're very rare in the population.

And they cant be used to make generalizations about differences between large groups of people.

Last year, I interviewed Paul Glimcher, a New York University social scientist whose research floored me. Glimcher plans to recruit 10,000 New Yorkers and track everything about them for decades. Everything: full genome data, medical records, diet, credit card transactions, physical activity, personality test scores, you name it. The idea, he says, is to create a dense, longitudinal database of human life that machine learning programs can mine for insights. Its possible this approach will elucidate the complex interactions of genetics, behavior, and environment that put us at risk for diseases like Alzheimers.

Computer science and biology are converging to make these audacious projects easier. And to some degree, the results of these projects may help us align our genes and our environments for optimal well-being.

Again, Posthuma cautions: Not all the predictions this research makes will be meaningful.

Do we care if we find a gene that only increases our height or our BMI or our intelligence with less than 0.0001 percent? she asks. It doesn't have any clinical relevance. But it will aid our scientific understanding of how intellect arises nonetheless.

And thats the bottom line. The scientists doing this work arent in it to become fortune tellers. Theyre in it to understand basic science.

What most people focus on, when they hear about genes for IQ, they say: Oh, no. You can look at my DNA. You can tell me what my IQ score will be, Posthuma says. They probably dont know its much better if you just take the IQ test. Much faster.

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Scientists are finding more genes linked to IQ. This doesn't mean we can predict intelligence. - Vox

When people talk about the gene-editing technology CRISPR, its usually accompanied by adjectives like revolutionary or world-changing. For this reason, its no surprise that a study out last month questioning just how game-changing the technology really is caused quite a stir.

Its well-known that using CRISPR can sometimes also result in some unintended genomic changes, and scientists have long been working on ways to fine-tune it. But the researchers found that when they had used CRISPR to cure blindness in mice, it had resulted in not just a few but more than a thousand, unintendedoff-target effects.

This finding warns that CRISPR technology must be further tailored, particularly before it is used for human gene therapy, the researchers wrote. The technique has already been used in two human trials in China, and next year one is slated to kick off in the US.

Their finding kicked off a battle for CRISPRs honor, with some researchers speaking out to question the studys methods while others piped up to agree that CRISPR is not yet ready for people.

The first criticism came the day after the study was published, via a comment from a researcher on PubMed who argued careless mistakes and flaws in the methodology cast serious doubts about the results or interpretation, concluding that it was hard to imagine CRISPR-cas9 causes so many [unintended] homozygous deletions in two independent mice.

On social media, scientists raised red flags about basic mistakes, such as misidentifying genes, mislabeling genetic defects, and the small number of animals the researchers had included in their research.

I think the Nature Methods paper was a false alarm on CRISPR induced mutations, the geneticist Eric Topol told Gizmodo. Ironically, the methods used were flawed. While we remain aware of such concerns unintended genomic effects that might occur with editingthat report was off-base.

Scientists from the CRISPR-focused companies Intellia Therapeutics and Editas Medicine sent separate letters to the journal, Nature Methods, chiming in with their own critique.

Based on the information available on the mouse study, the more plausible conclusion is that the genetic differences reflect a normal level of variation between individuals in a colony.

We believe that the conclusions drawn from this study are unsubstantiated by the disclosed experiments as they were designed and carried out, the scientists from Editas wrote. Further, it is impossible to ascribe the observed differences in the subject mice to the effects of CRISPR per se. The genetic differences seen in this comparative analysis were likely present prior to editing with CRISPR.

The study sent the stocks of those two companiesand a third, CRISPR Therapeuticstumbling. Nearly two weeks later, those market prices had still not fully recovered. Some went so far as to call for a retraction.

All of our methods are described in our peer reviewed Correspondence and sopplemental materials in Nature Methods and the raw data have all been publicly deposited, so that others may further learn from our data, one of the authors, Alexander Bassuk, told Gizmodo via email.

Springer Nature, which owns Nature Methods, said that they have received a number of communications regarding the paper and said that it had undergone peer review as all papers in the journal do.

We are carefully considering all concerns that have been raised with us and are discussing them with the authors, a spokesperson said.

On his blog, UC Davis professor Paul Knoepfler asked several scientists about the study and got mixed results. One cited the same flaws in methodology others have brought us. Another posited that it was a good reminder to hunt thoroughly for off-target effects.

Overall, this study adds a bit to the knowledge base, but it has been over-interpreted in the media, Knoepfler concluded. It was unlikely, he wrote, that so many unintended edits were occurring in most research, but it still suggested more studies to investigate the problem are necessary.

This brings us to the one thing that is definitely true: Despite all our recent progress, there is still a lot we dont know about CRISPR. It does indeed allow us to make precise gene edits more easily than ever before, but this ability has limitations that could wind up being disastrous if used in humans, and disappointing when genetically engineering everything else. CRISPR is still a nascent technology, and whether one day it might really be used to cure diseases or create a unicorn, there are still a whole lot of things that need to happen first.

Update: This story has been updated to include comments from one of the study authors, Nature Methods and Eric Topol.

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A Controversial Study Is Tearing the CRISPR World Apart - Gizmodo

Prof John Shine in 2015. Shine discovering a sequence of DNA now called the Shine-Dalgarno sequence which allows cells to produce proteins the basis for how all our cells operate. Photograph: Mal Fairclough/AAP

A man whose discovery was essential for the development of genetic engineering, and used that technology to create several therapies now helping many thousands of people, says receiving a Queens Birthday honour is a great recognition from the community of the value of scientific research.

John Shine started his career by discovering a sequence of DNA now called the Shine-Dalgarno sequence as part of his PhD in the mid 1970s.

That sequence, while a minuscule part of the human genome, allows cells to produce proteins the basis for how all our cells operate.

The discovery was essential for genetic engineering, spawned an entire biotech industry, and has now been used to produce therapies that have helped millions of people. In his own work, Shine used those techniques to clone of human insulin and growth hormone for the first time.

Other scientists honoured on Monday included astronomer Ken Freeman, who founded the field of galactic archaeology, and ethnobotanist Beth Gott.

Shine, who was appointed a Companion of the Order of Australia today, told the Guardian he has been unusually lucky in his career to have been able to oversee discoveries he made in basic sciences, be translated into real therapies and become commercialised.

My PhD was really esoteric research, he said, referring to his discovery of the Shine-Dalgarno sequence . But then I went over to San Francisco when gene cloning was just beginning right place, right time.

Shine had discovered how to clone the human gene that produces insulin, but to make that useful, it needed to be inserted into another organism that could be farmed in this case, bacteria, which would be farmed in large vats.

But if you want to put [the gene] into bacteria to make human insulin, you needed to trick the bacteria into thinking the gene was one of its own, he said.

It turned out Shines earlier discovery of the Shine-Dalgarno sequence was essential for making that final leap. Although the genetic code is the same in animals and bacteria, the regulatory code was very different. Thats where the Shine-Dalgarno sequence comes in, Shine said.

He needed to find the bacterias version of the Shine-Dalgarno sequence, and put that on either side of the human insulin gene, inside the bacteria.

You needed to put the right Shine-Dalgarno sequence just in front in the right place in the insulin gene to make the bacteria produce human insulin.

The fact that both problems were so closely related was mostly an accident, Shine says.

But throughout the rest of his career, Shine continued to be involved in the translation of his discoveries in esoteric science, all the way through to commercialisation.

Since stepping down as the head of the Garvan Institute in 2011 one of Australias top medical research institutes Shine has been the chair of the biotech giant CSL, one of Australasias largest companies.

So Ive come full circle, Shine said. CSL ... in more recent years, were moving into genetic engineering and weve released several genetically modified proteins for haemophilia that are changing the lives of thousands of people around the world.

Ive been very lucky to be able to go through the basic research in my career, and now see a lot of these real health care products come to fruition and improve the lives of thousands of people. Its wonderful when you can have all the excitement of research but also the satisfaction of seeing something very good coming out of it.

It is not the first time Shine has been recognised publicly for his work. In 2010 he won the prime ministers prize for science something his brother Rick Shine won in 2016.

Apart from the obvious personal honour, its a demonstration that the community does appreciate the benefits that come from research, Shine said. The wellbeing of any society is intimately linked to good healthcare.

Another winner of the prime ministers science prize, astronomer Ken Freeman, was appointed a Companion of the Order of Australia for his founding contributions to the field of galactic archaeology and his teaching work at the Australian National Universitys Mount Stromlo Observatory.

Honours were also awarded to Royal Melbourne hospitals Peter Grahame Colman (AM), for his work in endocrinology and diabetes research; aeronautical engineer Graeme Bird (AO), the former department head at the University of Sydney and a NASA consultant for 40 years; and Peter Klinken (AC), the chief scientist of Western Australia.

Ethnobotanist Beth Gott was made a Member of the Order of Australia for her work studying native plants and their use by Indigenous people. Gott founded Monash Universitys Aboriginal education garden in 1986 and has assembled databases of native plants in south-eastern Australia.

A paper she wrote in 2005 for the Journal of Biogreography found Indigenous fire-farming was crucial to the growth of plant tubers in southeastern Australia, allowing them to make up half of the local peoples diet.

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Scientist John Shine honoured for discovery that formed basis of genetic engineering - The Guardian

On the eve of the U.S. National Academies of Sciences and Medicine International Summit on Human Gene Editing, the Center for Genetics and Society and Friends of the Earth released a new report Extreme Genetic Engineering and the Human Future: Reclaiming Emerging Biotechnologies for the Common Good.

Read thefull reportor theexecutive summary.

Read the news release.

Summary: Recent research in genetic engineering and synthetic biology has enabled scientists to artificially redesign life --everything from microbes to people. Amid the breakneck speed of recent developments in genetic engineering and synthetic biology that could be used to alter human DNA, this report examines health, regulatory, social and ethical questions about proposals ranging from genetically altering human gut bacteria to implementing germline editing --altering human embryos and reproductive cells to produce permanent, hereditary genetic modification of future children and generations. It also examines the systemic and commercial incentives to rush newly discovered biotechnologies to market, regardless of their social utility and ahead of appropriate, transparent assessment and oversight.

The report calls for:

Background Emerging biotechnologies are enabling researchers and corporations to control and manipulate the basic building blocks of life. The impacts of these technologies are already rippling through society, as corporations patent our genes and those of other organisms.

Researchers hail synthetic biology --a new set of extreme genetic engineering techniques --as the future of manufacturing, engineering and medicine. Some of these techniques have also brought the prospect of genetically engineered humans closer to reality.

In April 2015, researchers from Sun Yat-sen University reported that they had used gene editing techniques to alter human embryos, the first time in history this is known to have occurred. In September 2015, a group of six major UK research funders and the Hinxton Group, an international consortium on stem cells and ethics, both released statements advocating for gene editing research in human embryos.

Recent genetic engineering discussions have focused on CRISPR/Cas9, a molecular complex intended to edit a genome by cutting out and/or splicing in parts of DNA sequences. This technique (which is not yet perfected, but is rapidly being refined) has been promoted as a promising tool to prevent genetic diseases. But, if used to modify embryos, it could result in permanent, heritable changes to future generations.

Risks and concerns There are significant scientific, environmental, health and ethical challenges to the human applications of synthetic biology, which currently include reengineering the human microbiome, gene drives, xenotransplantation and gene editing.

Prominent individuals and organizations, including some scientists working in the field, have expressed deep concerns about the unforeseen consequences that human applications of genetic engineering could have. Some believe there are lines that should not be crossed, especially attempts to create genetically modified human beings (sometimes called "designer babies"), and suggest that the risks to individuals and to society will never be worth any supposed benefit. Others argue that if its "safe," anything goes. A few even hypothesize that humanity will have a moral duty to genetically "enhance" our children if the technology and underpinning genetics progress.

Using gene editing at the request of health-impacted patients with specific diseases, often referred to as somatic gene therapy, may be acceptable, if it is feasible, proven safe and the patient understands implications of such procedures. But using the same techniques to modify embryos in order to make permanent changes to future generations and to our common genetic heritage --the human germline as it is known --is far more problematic. It is exceedingly difficult to justify on medical grounds, and carries enormous risks, both for individuals and society. The advent of human germline genetic engineering could lead to the development of new forms of social inequality, discrimination and conflict. Among the risks of heritable genetic modification is the possibility of a modern version of eugenics, with human society being divided into genetic haves and have-nots.

Lack of regulation Friends of the Earth believes that everyone needs to be aware of these new society-changing technologies and be able to engage in decisions about what is safe, ethical and beneficial.

Despite the outstanding environmental, safety and ethical concerns, the synthetic biology market is expected to reach close to $39 billion by 2020. Already products of synthetic biology, such as synthetic biology-derived vanillin, stevia and oils, are entering food and consumer products ahead of independent environmental and safety assessments, oversight and labeling --a worrying precedent for human applications.

Dozens of countries, including those with the most highly developed biotechnology sectors, have explicitly banned heritable human genetic modification, as has the Council of Europes binding 1997 Convention on Human Rights and Biomedicine. However, many countries, including the U.S., have not already enacted such a prohibition.

Friends of the Earth reiterates the call in "Principles for the Oversight of Synthetic Biology," signed by 116 civil society groups from around the world, for a prohibition on the use of gene editing and synthetic biology to manipulate the human germline; for safeguards to be implemented to protect public health and the environment from the novel risks of synthetic biology; and open, meaningful and full public participation in decisions regarding its uses. Countries that have not already adopted laws prohibiting the creation of genetically modified human beings, especially including the United States, should do so as soon as possible.

Further information on this topic and recommendations are outlined in the new report "Extreme Genetic Engineering and the Human Future."

Gene patents Synthetic biology techniques and applications for human engineering raise significant questions about intellectual property rights and the ownership of DNA.

About 20 percent of the human genome has already been patented by corporations and scientists, granting companies ownership and sole access to these fundamental building blocks of life. Gene patents are dangerous and unfair: They give corporations monopolies over potentially live-saving research and treatments that are based on pieces of genetic code that have evolved naturally over millenia and are part of our common human heritage.

Scientists are only beginning to understand the complexity of the human genome. Research to date indicates that many common diseases, including cancer, heart disease and Alzheimer's, correlate with a combination of environmental and genetic factors.

Patents on genes limit the ability of scientists and health researchers to learn more about gene-to-disease correlations and limit progress in fields that could benefit the health of all people, resulting in increasing prices for tests, impediments to alternative research and barriers to patients' access to potentially life-saving technology. As we've seen in the case of patents on two genes that correlate to increased risk for breast cancer and ovarian cancer, gene patents can also prevent patients from receiving second opinions on genetic diagnostic tests.

Friends of the Earth is working to ban the patenting of human genes and all genes that occur naturally on our planet. Our current focus is passing a bill in Congress that would end this practices in the U.S. by reinforcing a fundamental principle of patent law -- that patents only apply to new, non-obvious products that do not already occur in nature. Decoding genetic material is akin to figuring out the composition of water. Both water and genetic material are common goods that occur naturally. Neither should be patentable.

In a June 2013 decision, the Supreme Court ruled that human genes are may no longer be patented, invalidating the existing patents for over 20 percent of the human genome. Friends of the Earth, represented by the Center for Food Safety, had submitted an amici brief arguing that naturally occurring genes, DNA and cDNA must not be patentable. This marked a huge victory on the issue only apply to new, non-obvious products that do not already occurring in nature.

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Extreme Genetic Engineering and the Human Future

Diamondback moths. (Credit: Oxitec)

Though genetically modified crops may steal the spotlight, similarly reprogrammed insects may have just as big an effect on the agricultural industry.

Biotechnology company Oxitec is moving forward withplans to develop genetically engineered diamondback moths in an attempt to reduce populations of the invasive crop pest. Their plan is to release males that will pass on a gene preventing female offspring from reaching maturity and reproducing, which they say will eventually eradicate the moths in North America. Tests have so far been positive, although there are still worries about the prospect of releasing genetically modified organisms into the wild.

Currently, pesticides are used to control the moths, which are responsible for an estimated $5 billion worth of damage every year in the U.S. An invasive species, the diamondback moth originated in Europe, but has proved difficult to control since appearing the U.S. due to short gestation times and the large numbers of eggs females lay at once. Oxitec says that their technique is preferable to pesticides, as the moths have proven capable of evolving resistance to the compounds in the past, and most carry some risk to the environment and human health.

Oxitec cites a USDAanalysis that found no risk of significant impact in an earlier test of the GM moths as evidence that their technique is safe, but the prospect of GM insects raisesfears that the moths may proliferate beyond targeted areasand cause impacts on the broader ecology. Similar techniques have been applied before, reaching as far back as the 1950s when sterile screwworm flies were released in Florida, effectively eliminating the parasitic species there. Impotent mosquitos, also manufactured by Oxitec, have been used to combat Zika in South America, andplans to implement the same procedure in Florida are underway.

The successful screwworm campaign relied on blasts of radiation to sterilize the males. Oxitecs technique uses gene editing engineering to implant males with modified DNA that ensures female caterpillars dont survive to adulthood. In the case of the moths, males need not be targeted because it is only the female caterpillars who are responsible for damaging the crops.

They say that tests of the moths, including feeding them to various animals and releasing them in greenhouses, have revealed no ill effects as a result of the genetic modification. Along with the caterpillar-killing gene, the moths are also implanted with a gene that causes them to fluoresce red under UV light, the better to identify them in the wild.

The FDA found no issues preventing the company from moving forward, but because the moths are an agricultural pest, the USDA must weigh in as well.Oxitec is currently waiting on USDA approval to conduct expanded tests at a site in New York in conjunction with Cornell University. They hope to release the moths in a contained cabbage field to see how effective their modifications are.

Most opposition to genetically modified insects is based on the prospect of altered organisms spreading beyond the areas they are released. In the case of the diamondback moth, Oxitec says that the nature of the modification, which precludes breeding, should serve to limit the spread of the GM moths, and pesticides and freezing winter conditions should take care of the rest. While there is a precedent for this kind of technique in screwworms, those insects were uniquely suited to sterilization-based population control because of their life-cycles. Moths may present additional challenges.

Kevin Esvelt, a professor at MIT and leader of the Sculpting Evolution Lab agrees that the general concept is sound: The wholepoint is to harm the next generation of organisms. And since they carry the relevant genetic construct, its necessarily going to decrease, he says. It will not persistin the environment over time as long as the genetic construct is doing what its supposed to do.

This marks a crucial difference from a gene drive, a technique often associated with genetically modifying populations. The hallmark of a gene drive is tweaking genes to increase the chances that a particular trait will be passed on to offspring. The odds are normally 50/50, but a gene drive can tilt them in favor of a particular set of genes,causing a trait to spread through a population. This is helpful when a trait is detrimental to an organisms survival and would normally be weeded out by natural selection. Gene drives havent yet been applied in the wild, though, and likely wont be for many years.

Oxitecs moths possess nosuch scale-tipping modifications that could cause the modified genes to spread across the globe, they merely pass on genetic material in the normal way. Part of this genetic material, however, has been changed to ensure that female caterpillars with the gene dont survive.

From a technical perspective its a perfectly sound approach, it probably offers fewer risks than current approaches using pesticides. In general I am a fan of usingbiology to solve ecological problems as opposed to chemistry, Esvelt says.

Still, he says that field trials are an important step in testing the efficacy and safety of any genetically modified organism. Along with careful tests, Esvelt advocates for more community involvement in the decision making process, as well attempts to reach out and communicate with critics. Although both the FDA and USDA have a period in place during which the public can comment, Esvelt says more communication should be done earlier.

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After Mosquitos, Moths Are the Next Target For Genetic Engineering - Discover Magazine (blog)