Archive for the ‘Gene Therapy Research’ Category

AMSTERDAM, The Netherlands, February 21, 2012 /PRNewswire/ --

Amsterdam Molecular Therapeutics (Euronext: AMT - News), a leader in the field of human gene therapy, announced today that it has received a request to provide additional information to the Committee for Human Medicinal Products (CHMP) on Glybera® (alipogene tiparvovec) by March 8, 2012. The CHMP request follows the announcement on January 30, 2012 that the European Commission Standing Committee was requesting additional information from the CHMP. The CHMP has indicated that a final decision on Glybera could be made by May 2012.

Glybera is a gene therapy for patients with the genetic disorder LPLD, a very rare inherited condition that is associated with increased levels of chylomicrons. These particles carry certain types of fat in the blood, which because they are not removed from the body can cause recurrent bouts of pancreatitis. There is no treatment currently available for these patients.

On October 23, 2011, AMT received a non-approvable opinion from the CHMP (following a re-examination of the marketing approval dossier originally rejected in June 2011) despite a recommendation to approve Glybera by the Committee for Advanced Therapies (CAT). The CAT is an expert body implemented by the European Commission to prepare and advise the CHMP on decisions regarding advanced therapeutics, in particular gene and cell therapies. 

AMT's proposed acquisition of assets by uniQure BV announced on February 17, 2012, was developed on the basis that Glybera is not approvable. This transaction will proceed as planned. In the event that Glybera could be commercialized in Europe, uniQure will evaluate how achieving this important milestone could be realized most efficiently.

About Glybera®

AMT has developed Glybera as a treatment for patients with the genetic disorder lipoprotein lipase deficiency.

LPLD is an orphan disease for which no treatment exists today. The disease is caused by mutations in the LPL gene, resulting in highly decreased or absent activity of LPL protein in patients. This protein is needed in order to break down large fat-carrying particles that circulate in the blood after each meal. When such particles, called chylomicrons, accumulate in the blood, they may obstruct small blood vessels. Excess chylomicrons result in recurrent and severe acute inflammation of the pancreas, called pancreatitis, the most debilitating and life threatening clinical complication of LPLD. Glybera has orphan drug status in the EU and US.

About Amsterdam Molecular Therapeutics

AMT is a world leader in the development of human gene based therapies. AMT has a product pipeline of gene therapy products in development for hemophilia B, acute intermittent porphyria, Parkinson's disease and SanfilippoB. Using adeno-associated viral (AAV) derived vectors as the delivery vehicle of choice for therapeutic genes, the company has been able to design and validate probably the world's first stable and scalable AAV manufacturing platform. This proprietary platform can be applied to a large number of rare (orphan) diseases caused by one faulty gene and allows AMT to pursue its strategy of focusing on this sector of the industry.  AMT was founded in 1998 and is based in Amsterdam. Further information can be found at http://www.amtbiopharma.com.

About uniQure

uniQure BV is a private company created specifically for the transaction with AMT. It is funded by Forbion Capital Partners, an existing investor in AMT. uniQure will act as the new holding company for the gene therapy business currently carried out by AMT.

Certain statements in this press release are "forward-looking statements" including those that refer to management's plans and expectations for future operations, prospects and financial condition. Words such as "strategy," "expects," "plans," "anticipates," "believes," "will," "continues," "estimates," "intends," "projects," "goals," "targets" and other words of similar meaning are intended to identify such forward-looking statements. Such statements are based on the current expectations of the management of AMT only. Undue reliance should not be placed on these statements because, by their nature, they are subject to known and unknown risks and can be affected by factors that are beyond the control of AMT. Actual results could differ materially from current expectations due to a number of factors and uncertainties affecting AMT's business. AMT expressly disclaims any intent or obligation to update any forward-looking statements herein except as required by law. 

Not for release, publication or distribution in whole or in part, directly or indirectly, in or into the United States or to US persons. This announcement is not a prospectus and does not contain or constitute an offer for sale or the solicitation of an offer to purchase securities in the United States or any other jurisdiction.

The securities mentioned herein have not been and will not be registered under the U.S. Securities Act of 1933, as amended (the "Securities Act"), or under the securities laws of any state or other jurisdiction of the United States and may not be offered, sold, resold, taken up, exercised, renounced, transferred or delivered, directly or indirectly, within the United States except pursuant to an applicable exemption from, or in a transaction not subject to, the registration requirements of the Securities Act. No public offering of the securities mentioned herein is being made in the United States or any other jurisdiction.

This announcement does not constitute or forms a part of any offer or solicitation to purchase or subscribe for securities in any jurisdiction or jurisdictions in which such offers or sales are unlawful prior to registration or qualification under the securities laws of any such jurisdiction.

The materials contained herein have not been submitted to or reviewed by the US Securities and Exchange Commission (the "SEC") or any state securities commission, and neither the SEC nor any such state securities commission has (a) approved or disapproved, (b) passed upon the merits or fairness of, or (c) passed upon the adequacy or accuracy of the disclosure of any materials contained herein. Any representation to the contrary is a criminal offence in the United States.

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Amsterdam Molecular Therapeutics Receives Request for Further Information From CHMP on Glybera®

20-12-2011 08:50 If you would like more information please call us Toll Free at 877-578-7908. Or visit our website at http://www.usastemcells.com Or click here to have a Free Phone Constultation with Dr. Matthew Burks usastemcells.com Real patient testimonials for USA Stem Cells. Adult stem cell therapy for COPD, Emphysema, and Pulmonary fibrosis.

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Adult Stem Cell Treatments for COPD - Real patient results, USA Stem Cells - Marian H. Testimonial - Video

29-11-2011 03:32 The MiSeq system is a fully integrated sequencing ecosystem, in a compact and economical instrument. For results in hours, not days, MiSeq uses TruSeq, Illumina's reversible terminator-based sequencing by synthesis chemistry to deliver the fastest time to answer. Perform the widest breadth of sequencing applications, including highly multiplexed PCR amplicon sequencing, small genome resequencing and de novo sequencing, small RNA sequencing, library quality control, and 16S metagenomics, with automated, on-instrument data analysis workflows to take your research further. The widest breadth of applications As the only personal sequencer capable of producing paired-end reads, the MiSeq system puts the largest portfolio of sequencing applications at your fingertips. Optimized sample preparation kits, push-button sequencing, and automated data analysis, create the first truly end-to-end sequencing solution. View the full list of Illumina supported applications See what's possible View the Application Notes: Nextera sample prep for the MiSeq system Sequencing's fastest sample prep delivers quality de novo assembly of small genomes. Sequencing Library QC on the MiSeq system Pre-configured, automated QC workflows prior to a large-scale sequencing study. Amplicon sequencing from FFPE tissues on the MiSeq system Simple and fast workflow for accurate detection of rare variants even from degraded DNA. High-speed, multiplexed microbial sequencing on the MiSeq System Researchers at the ...

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MiSeq Personal Sequencing System - Video

12-01-2012 14:59 Scientists at Westmead Millennium Institute for Medical Research were amazed to see a cell literally laughing at them. Scientists were researching how a cancer-causing protein called Beta Catenin (green) moves into the cell nucleus (the round "face" shape). "Sometimes you feel like diseases really are laughing at your attempts to destroy them, and here it is under our microscope!" says Beric Henderson, head of WMI's gene expression laboratory. Please credit Westmead Millennium Institute for Medical Research if using this.

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smiley face.avi - Video

01-02-2012 09:24 Please Subscribe To The EvolutionDocumentary YouTube Channel: http://www.youtube.com Broadcast (2005) In 1973, two scientists, Herb Boyer and Stan Cohen, became the first genetic engineers when they transferred the DNA from one species to another. Their experiment triggered a wave of controversy about the dangers of genetic manipulation, but it also generated a multi billion dollar industry. Was altering the genetic makeup of plants and animals a threat to humanity or the key to alleviating a host of health problems? Biologists, along with lawyers and journalists from all over the world, were called to a meeting in California to decide the future of DNA research. Biotechnology would soon transform the pharmaceutical industry and genetically modified food was to herald the biggest revolution in agriculture since the industrialization of farming. Yet the public was skeptical, and so were certain scientists. Some feared that a cancer causing gene stitched into the DNA of a bacterium might be accidentally absorbed in the human gut, enabling cancer to be passed on like an infectious disease. Biologists from all over the world were called to a meeting in to draw up a strict set of safety guidelines. When the panic subsided the stage was set for a biotechnology bonanza. A race began to produce genetically engineered insulin. A couple of years later a young researcher called Rob Horsch, who worked for the chemical giant Monsanto, produced the first genetically engineered plant. The ...

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DNA Episode 2 Playing God (PBS) - Video

24-01-2012 16:27 X inactivation is a vital process that occurs in all DNA-containing cells of the female body. It is also an important research model and tool for studying epigenetics. Epigenetics refers to processes that tell our cells how, and when, to read the DNA blueprint. The epigenetic regulation of DNA is critical in both normal development and disease. X inactivation is a type of gene dosage compensation. In humans, the sex chromosomes X and Y determine the sex of an individual - females have two X chromosomes (XX), males have one X and one Y chromosome (XY). All of the genes on the Y chromosome are required in male development, while the genes on the X chromosome are needed for both male and female development. Because females receive two X chromosomes, they inherit two copies of many of the genes that are needed for normal function. Extra copies of genes or chromosomes can affect normal development. An example is Down's syndrome, which is caused by an extra copy of part or all of chromosome 21. In female mammals, a process called X inactivation has evolved to compensate for the extra X chromosome. In X inactivation, each cell 'switches off' one of its X chromosomes, chosen at random, to ensure the correct number of genes are expressed, and to prevent abnormal development.

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X Inactivation and Epigenetics - Video

22-01-2012 17:29 There is no difference between natural foods and genetically modified foods? That's not what research says. This documentary discusses those who have spoken out against the scientific government scam of genetically modified foods and have been fired, harassed and other things as well as the results of their research.

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Scientists Under Attack: Genetic Engineering in the Magnetic Field of Money - Video

24-12-2011 12:55 Research interests include cellular neuroscience, developmental biology and genetics, immunology, microbiology and lipid transport, in both plants and animals. Molecular mechanisms that control cell structure and function as well as the organization of cells into complex organs or organ systems within single organisms. How do the cells respond to stress? How is the expression of key proteins regulated? How do cells use energy ? How do cells make your heart beat - your brain think - your eyes see? How does the action of individual cells translate into working organs and systems? How do the cells organize themselves into complex organs or organ systems in such a way that the whole is greater than the sum of its parts? How can certain organisms survive in an extreme environment? Further career and educational opportunities: The Cells, Molecules and Physiology stream prepares students for careers in Medicine, Diagnostics, Biotechnology and Pharmaceuticals, Cancer Research, Bioengineering, Forensics, Science Writing, Science Education, Genetic Counseling, Dentistry, Veterinary Medicine, consulting in the areas of toxicology, fisheries, and more. Practical knowledge Learn about the science behind the headlines: understand the new developments in how we identify and treat illnesses, modify crops for drought tolerance and higher nutrition, clone cells and organisms. This video includes interviews with graduate students and professors in Biological Sciences at SFU.

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Program in Cellular and Molecular Biology at Simon Fraser University - Video

08-12-2011 08:35 In 1865 Augustinian monk Gregor Mendel discovered the basic laws of heredity.

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Milestones of Science - Gregor Mendel and Classical Genetics - Video

08-02-2012 12:15 Joan shares her family story of bipolar disorder and her journey as a mental health advocate. This workshop is part of a genomics curriculum for practicing healthcare providers developed by the Genomic Medicine Institute at El Camino Hospital, Genetic Alliance, and the National Coalition for Health Professional Education in Genetics. This workshop, the fifth in a 10-part series, covered understanding genetic contribution to schizophrenia, major depression, hypertension, and diabetes; risk assessment for complex conditions; establishing diagnosis; pharmacogenomics; gene-environment interaction; and management.

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Workshop 5: Genetics of Complex Disease - Joan Esnayra - Video

EDMOND, OK--(Marketwire -02/19/12)- The team of veterinarians at White Oaks Veterinary Clinic in Edmond announced that the animal hospital is now offering pet stem cell therapy. This new regenerative medicine for pets helps animals suffering from degenerative joint disease or arthritis. Based on the research and technology provided by a company called Stemlogix, White Oaks Veterinary Clinic can now offer affordable, same-day stem cell therapy to dogs suffering from these debilitating conditions. The Stemlogix technology enables the Edmond veterinarians to extract adult stem cells from a pet's own body fat, virtually eliminating the risk of rejection or negative reaction.

"I see far too many otherwise healthy pets at our veterinary clinic that have been hobbled by the effects of arthritis," Dr. Jennifer Bianchi said. "We're thrilled to be able to offer this holistic solution which harnesses the pet's own healing power to aid in the pain relief process. Our main goal with stem cell therapy is to reduce long-term inflammation and slow the progression of cartilage damage. The motto at our veterinary hospital is, 'Quality service at a great value.' Being able to provide stem cell transplants in about two hours at an affordable rate helps us live up to that promise and makes me happy to think of the pets we'll be able to help move freely again."

The veterinary hospital now has an on-site stem cell laboratory for producing stem cells. The on-site lab allows for immediate processing after extraction as the stem cells have a limited lifespan outside of the pet's body. Once the fat cells have been procured from the pet, the stem cells are isolated and returned back to the host body within ninety minutes. Stemlogix promotes this therapy as being able to relieve pain and increase range of motion in pets suffering with joint pain, arthritis, tendon and ligament damage, hip dysplasia and cartilage damage.

Once implanted, stem cells have the ability to stimulate regeneration, reduce pain and inflammation, and assist in the repair of damaged tissue. They can also differentiate into other cell types such as tendon, cartilage, bone, and ligament, which may further aid the repair process. The Edmond veterinarian says that pain relief can be expected within a few days to a few weeks. Pet owners are cautioned to gradually allow their pets to experience increased activity so as not to interfere with the healing process.

As a holistic veterinarian, White Oaks Veterinary Clinic combines natural healing techniques, such as pet acupuncture, with traditional veterinary medical services. The animal hospital was founded in 1997 and is currently practicing out of a 6500 square foot facility. Equine vet, Dr. Mark Bianchi, offers general and advanced services such as surgery, equine dentistry, lameness evaluations and reproduction consultations.

White Oaks Veterinary Clinic is located at 131 W. Waterloo Rd. Further information on the animal hospital or pet stem cell therapy may be obtained by visiting the website at http://www.whiteoaksvet.com.

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Edmond Veterinary Hospital Offers Pet Stem Cell Therapy for Arthritis

SUNDAY, Feb. 19 (HealthDay News) -- A new animal study suggests that a genetic mutation could put certain people at higher risk for becoming obese if they eat high-fat diets.

At the moment, the practical uses of the research seem to be limited, but physicians could conceivably test people for the mutation and recommend that they avoid certain kinds of diets, said study co-author Dr. Gozoh Tsujimoto, a professor at Kyoto University's department of genomic drug discovery science in Japan. It may also be possible, Tsujimoto said, to eventually give people drugs to combat the effects of the mutation.

If that happens, there would be "a new avenue for personalized health care," Tsujimoto said.

Scientists have been busy studying genetic links to obesity that could make some people more prone to gain extra weight. Two-thirds of Americans are either overweight or obese, the U.S. Centers for Disease Control and Prevention estimates. Excess pounds contribute to a variety of diseases, including heart disease and cancer.

In the new study, researchers looked at the component of the body's internal communication system that plays a role in the regulation of appetite and the production of fat cells.

The investigators found that mice that didn't have the component were 10 percent fatter than other mice when all were fed a high-fat diet. Mice without the component also developed higher intolerance to glucose.

Research conducted in animals does not always translate into humans, and much more research is needed. However, the researchers found that Europeans with the genetic mutation, known as GPR120, were more likely to be obese.

"Our study for the first time demonstrated the gene responsible for diet-induced obesity," Tsujimoto said.

According to Tsujimoto, more than 3 percent of Europeans have the trait. The next step for researchers is to study its prevalence in Japanese, Korean and Chinese people.

What can be done with the knowledge from the study?

Tsujimoto said physicians could advise people with the trait to avoid high-fat diets. A test is available to detect the trait and it costs about $200 in Japan, Tsujimoto said.

While medications could potentially be developed that would reverse the effects of the genetic trait, there are no such drugs now, Tsujimoto added.

Ruth Loos, director of Genetics of Obesity and Related Metabolic Traits at Mount Sinai School of Medicine in New York City, said "these findings provide another piece of what turns out to be the very large puzzle that describes the causes of obesity."

Consistent findings in mice and humans have put the trait "more firmly on the obesity map and provides a new starting point for more research into the function of this gene," said Loos.

"This is only the beginning of likely many years of research to disentangle the physiological mechanisms that lie behind the link between this gene and obesity risk," she said. "It is only when we understand the physiology and biology better that one can start thinking of developing a drug."

The study appears online Feb. 19 in the journal Nature.

More information

For more on obesity, visit the U.S. National Library of Medicine.

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Gene Might Boost Risk for Obesity

ScienceDaily (Feb. 19, 2012) — Global warming has forced alpine chipmunks in Yosemite to higher ground, prompting a startling decline in the species' genetic diversity, according to a new study by researchers at the University of California, Berkeley.

The study, appearing Feb. 19, in the advance online publication of the journal Nature Climate Change, is one of the first to show a hit to the genetic diversity of a species because of a recent climate-induced change in the animals' geographic range. What's more, the genetic erosion occurred in the relatively short span of 90 years, highlighting the rapid threat changing climate can pose to a species.

With low genetic diversity a species can be more vulnerable to the effects of inbreeding, disease and other problems that threaten species survival, the researchers said.

"Climate change is implicated as the cause of geographic shifts observed among birds, small mammals and plants, but this new work shows that, particularly for mountain species like the alpine chipmunk, such shifts can result in increasingly fragmented and genetically impoverished populations," said study lead author Emily Rubidge, who conducted the research while a Ph.D. student at UC Berkeley's Museum of Vertebrate Zoology and the Department of Environmental Science, Policy and Management. "Under continued warming, the alpine chipmunk could be on the trajectory towards becoming threatened or even extinct."

Rubidge worked with Craig Moritz, professor of integrative biology and director of the Museum of Vertebrate Zoology; James Patton, professor emeritus of integrative biology and curator of the Museum of Vertebrate Zoology; and Justin Brashares, associate professor in the Department of Environmental Science, Policy and Management.

The new findings build upon previous research that found major shifts in the range of small mammals in Yosemite National Park since the early 1900s. In 2003, biologists at UC Berkeley began an ambitious resurvey of Yosemite's birds, mammals, reptiles and amphibians, retracing the steps originally taken between 1914 and 1920 by Joseph Grinnell, founder and former director of the Museum of Vertebrate Zoology.

The Grinnell Resurvey Project, led by Moritz and museum colleagues, found that many small mammals in Yosemite moved or retracted their ranges to higher, cooler elevations over the past century, a period when the average temperature in the park increased by 3 degrees Celsius, or about 5.4 degrees Fahrenheit.

It is no surprise that the alpine chipmunk (Tamias alpinus) would be more sensitive to the temperature change, since it is a high-elevation species endemic to California's Sierra Nevada, the researchers said. In the early 1900s, Grinnell and colleagues sighted alpine chipmunks at elevations of 7,800 feet. Now, the alpine chipmunk appears to be sticking to even higher elevations, retracting its range by about 1,640 feet upslope.

To test the genetic impact from that loss of geographic range, researchers compared genetic markers from 146 modern-day alpine chipmunks with those from 88 of their historical counterparts. Samples were collected from seven paired sites throughout Yosemite.

As a control, the researchers also looked at the genetics -- both historic and modern -- of lodgepole chipmunks (Tamias speciosus), a lower elevation species that had not changed its range over the past century.

The analysis of genetic markers revealed a significant decline in "allele richness" among the recently sampled alpine chipmunk populations compared with their historic counterparts. Moreover, the researchers noted that the modern chipmunks were more genetically differentiated across sites than in the past, a sign of increased fragmentation in the alpine chipmunk population.

In comparison, there were no significant changes in genetic diversity detected among the lodgepole chipmunks, a species found at elevations from 4,900 to 9,800 feet.

"Much of what we read and hear about the effects of climate change on biodiversity is based on model projections and simulations, and these models typically involve many moving parts and lots of uncertainty," said Brashares. "Thanks to the baseline provided by Joseph Grinnell's pioneering efforts in the early 20th century, we are able to go beyond projections to document how climate is altering life in California. The research led by Emily is novel and important because it shows empirically that climate change has led to the loss of genetic diversity in a wild mammal over the last several decades."

Moritz added that this study exemplifies how patterns of change in California's ecosystems can be uncovered through analyses of fossil, historic and modern records.

"At the heart of this whole enterprise is the incredibly dense historic record and specimens we have at UC Berkeley from 100 years ago," said Moritz. "These collections allow us to conduct sophisticated analyses to better understand how ecosystems are reacting to environmental changes, and to create more detailed models of future changes."

Other study co-authors are Marisa Lim, a UC Berkeley undergraduate student in integrative biology; and Cole Burton, former UC Berkeley graduate student in environmental science, policy and management (now a research associate at the University of Alberta in Canada).

Funding for this research was provided by the Natural Sciences and Engineering Research Council of Canada, UC Berkeley's Museum of Vertebrate Zoology, the Yosemite Fund, the National Geographic Society and the National Science Foundation.

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Journal Reference:

Emily M. Rubidge, James L. Patton, Marisa Lim, A. Cole Burton, Justin S. Brashares, Craig Moritz. Climate-induced range contraction drives genetic erosion in an alpine mammal. Nature Climate Change, 2012; DOI: 10.1038/nclimate1415

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Yosemite's alpine chipmunks take genetic hit from climate change

Dr. Elizabeth Berry-Kravis has spent much of her career focused on Fragile X, a genetic condition involving a mutation on the X chromosome that causes cognitive disabilities, behavioral issues and other problems.

New medications and therapeutic interventions have revolutionized life for people with the syndrome over the past 20 years, but Berry-Kravis, who runs the Fragile X Clinic and Research Program at Rush University in Chicago, said the most exciting discoveries are being explored now.

She was in Houston recently for a meeting of the Fragile X Clinical and Research Consortium at Texas Children's Hospital and spoke with Chronicle reporter Jeannie Kever.

Q. Tell me a little about Fragile X. How many people does it affect, and how does it manifest?

A. The description everyone uses is, it's the most common inherited form of intellectual disability. It's also the most common known genetic cause of autism. Children will seem pretty normal as young babies, but then they'll present to their pediatrician with a delay in walking or acquiring other motor milestones. A delay in talking is common. They'll have ongoing learning difficulties.

In elementary school, most of the guys with Fragile X will be in special education and have occupational therapy, speech therapy. Fragile X patients have a lot of behavioral difficulties, hyperactivity, problems paying attention, sometimes more aggressive behaviors.

It occurs in about 1 in 4,000 people. The gene that causes Fragile X is on the X chromosome. Men have only one copy of the X chromosome; girls have two. In girls, the normal gene on the other X chromosome tends to make the condition milder.

Q. What are researchers looking at?

A. The research that is particularly exciting, we have a mouse that has Fragile X. The mouse brain looks very similar to the human brain (of someone with Fragile X), so we can study the mechanisms of disease in the mouse.

Now we are working on treatments to target those pathways ... to try to improve the brain cell connections. We can show that certain agents actually work in the mouse to impact different behaviors.

Some of those are being translated into humans. Now, if a patient has attention problems, we would treat it with medicine. But these new medications are targeted to the actual (behavior-causing) mechanisms.

Q. Is that a new approach?

A. It hasn't been done before in a developmental disorder, so Fragile X has become very hot in the research world. What's happening here will become a model for developing treatments for Down syndrome and autism.

Currently, three drugs are in clinical trials. We don't know really how well the drugs are going to work in people yet. We're very hopeful, but we have to remind ourselves the human is not the mouse.

If these drugs do produce improvements, and particularly if they produce cognitive improvements, which has never been done, it would be pretty earth-shaking.

Q. What does that mean for people with Fragile X and their families?

A. In the past, patients with Fragile X were very difficult. They couldn't be handled in the schools. There weren't good medications to help with their symptoms. They would be excluded from society.

They also tended to acquire very few academic skills, because people believed they weren't teachable. Now we've seen a revolution in teaching these patients. Even without the new drugs, the advances in the past 10 or 20 years about early intervention, molding education to the child ... has made a big improvement.

With the advance of behavioral drugs, we can manage the behavior with medications and therapy and educational strategies. More of my patients now are getting out of high school and getting into a job.

If we could treat the biology at least a little bit with these new medications, we would see an added bonus.

jeannie.kever@chron.com

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Research helps demystify a genetic disorder

By Joe Schneider - Mon Feb 20 03:12:04 GMT 2012

Myriad Genetics Inc. (MYGN) and other biotechnology companies can’t monopolize treatment for diseases by patenting human genetic material, an Australian trial was told in the first challenge in the country over the ownership of DNA molecules.

Cancer Voices Australia, a national organization representing people diagnosed with cancer, and Yvonne D’Arcy, a Brisbane resident diagnosed with breast cancer, sued Myriad Genetics and Genetic Technologies Ltd. (GTG) in 2010 over a patent the companies have on a gene mutation associated with an increased risk of breast and ovarian cancers.

“Patents protect inventions, not discoveries,” Rebecca Gilsenan, a partner at Maurice Blackburn Lawyers, who represents the plaintiffs, said before the trial. “No Australian court has considered the question of whether isolated human genes are patentable.”

Gene-sequencing breakthroughs are spawning a multibillion- dollar market for drugs and medical tests. In the U.S., health regulators are developing rules for bolstering oversight of laboratory-developed tests and the U.S. Supreme Court may decide tomorrow whether to hear two cases involving patents over genetic material, including a review of an appeals court decision that upheld Myriad Genetics’ patents.

Myriad Genetics, based in Salt Lake City, contends in the Australian case that it’s not seeking to patent a gene but an artifically-created screening process aimed at identifying a mutation that makes people more susceptible to breast and ovarian cancers.

“You can’t use this to build another human being,” David Shavin, Myriad Genetics’ lawyer, told Federal Court Justice John Nicholas today in his opening statement at the start of the trial in Sydney, referring to the patented screening process. “All you can use it for is to compare” and identify the mutated genes.

Australian law allows for patents on artificially created products with economic benefits, including computer programs and business methods, Shavin said.

“The position in the United States is similar to, but not the same as, in Australia,” he said.

The trial is scheduled to take as long as eight days.

“There is a philosophical and ethical issue about the commercialization of the human body,” Gilsenan said. “The patent owner has a right to prevent people from studying and testing for the gene mutation, so gene patents can stifle research.”

The case is: Cancer Voices Australia v. Myriad Genetics. NSD643/2010. Federal Court of Australia (Sydney).

To contact the reporter on this story: Joe Schneider in Sydney at jschneider5@bloomberg.net

To contact the editor responsible for this story: Douglas Wong at dwong19@bloomberg.net

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Myriad Genetics’ Australian Cancer Gene Patents Go on Trial in Sydney

ScienceDaily (Feb. 16, 2012) — Genetic information provided by a large group of specially-designed mice could pave the way to faster human health discoveries and transform the ways people battle and prevent disease.

In 15 papers published Feb. 16 in the Genetics Society of America journals Genetics and G3:Genes/Genomes/Genetics, researchers from North Carolina State University, the University of North Carolina at Chapel Hill, The Jackson Laboratory and other universities and labs across the globe highlight a new genetic resource that could aid development of more effective treatments for any number of human diseases.

The resource, known as the Collaborative Cross (CC), is a reference manual of genetic variation contained in hundreds of specially-bred mice and their genetic sequences. The CC mice have much more genetic variation than normal lab mice, and thus more closely mirror the genetic complexity found in humans.

Moreover, the mice and their genetic sequences will be publicly available, allowing researchers around the world to work with mice that have particular genetic variations.

"If you can't mimic the genetic variation in people, you can't necessarily use mouse findings to understand more about human disease," says Dr. David Threadgill, professor and department head of genetics at NC State who originally proposed the idea for the CC project a decade ago and who serves as one of the project leaders. Threadgill is also a member of the University of North Carolina's Lineberger Comprehensive Cancer Center.

Threadgill developed the idea for the CC in order to harness the power of so-called whole genome studies that examine all genes at once instead of subsets of genes. Complex interactions between large numbers of genes frequently govern traits and behavior. Learning more about these interactions could help researchers tease out links between certain genes and certain diseases, for example.

In one of the 15 papers, Threadgill and corresponding author Dr. Francis S. Collins, director of the National Institutes of Health, identify key genes involved in red and white blood cell counts and red blood cell volume. These hematological parameters are important indicators of health and disease.

Project leaders include Dr. Fernando Pardo-Manuel de Villena of the UNC Department of Genetics, who is a member of UNC Lineberger Comprehensive Cancer Center, and Dr. Gary Churchill at The Jackson Laboratory. The international consortium participating in the development of the CC project includes NC State, UNC-Chapel Hill, The Jackson Laboratory, Tel Aviv University, Oxford University and Geniad/Australia. The mice are housed and "curated" at UNC-Chapel Hill.

The research was supported by grants from the National Institutes of Health; Ellison Medical Foundation; National Science Foundation; Australian Research Council; and the Wellcome Trust. The University Cancer Research Fund from the state of North Carolina also provided important funding.

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The above story is reprinted from materials provided by North Carolina State University, via Newswise.

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Journal Reference:

S. N. P. Kelada, D. L. Aylor, B. C. E. Peck, J. F. Ryan, U. Tavarez, R. J. Buus, D. R. Miller, E. J. Chesler, D. W. Threadgill, G. A. Churchill, F. Pardo-Manuel de Villena, F. S. Collins. Genetic Analysis of Hematological Parameters in Incipient Lines of the Collaborative Cross. G3: Genes|Genomes|Genetics, 2012; 2 (2): 157 DOI: 10.1534/g3.111.001776

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Disclaimer: This article is not intended to provide medical advice, diagnosis or treatment. Views expressed here do not necessarily reflect those of ScienceDaily or its staff.

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New mouse reference library should speed gene discoveries

February 17, 2012, 6:33 PM EST

By Kristen Hallam

(Updates with Life, Illumina shares in fifth paragraph.)

Feb. 17 (Bloomberg) -- Oxford Nanopore Technologies Ltd. is entering the gene-sequencing race with a new portable device that will allow people to analyze DNA on the go.

The product, called MinION, is about the size of a USB memory stick, the closely held Oxford, England-based company said today. MinION will be ready for sale in the second half of the year at a cost of less than $900. It’s a smaller version of the GridION device that Oxford Nanopore is developing.

Oxford Nanopore is relying on the two products to spur demand for machines that can decode the building blocks of life, helping to identify new targets for medicines and illuminate crop science. The company is jumping into a market led by Life Technologies Corp. and Illumina Inc., which last month said they’ve built products that can sequence a genome in a day. GridION is designed so that computing equipment can be clustered to sequence an entire human genome in as little as 15 minutes.

“The USB stick is an absolute game-changer,” Oxford Nanopore Chief Executive Officer Gordon Sanghera in a telephone interview. “It’s plug-and-play, on-the-go DNA sequencing.”

Life Technologies fell 4.3 percent to $47.66 at 1:15 p.m. in Nasdaq Stock Market trading after dropping as much as 7 percent, the biggest intraday decline since Oct. 7. Illumina dropped 2.9 percent to $52.39 after falling as much as 4.5 percent.

Tiny Hole

The company presented data on the two products today at the Advances in Genome Biology and Technology conference in Florida. The devices use a novel technique known as strand sequencing, in which an entire string of DNA is guided by an enzyme and passes intact through a tiny hole in a cell membrane one-billionth of a meter wide, like a child sucking spaghetti through his mouth.

The strand-sequencing technique relies on an engineered protein or nanopore that creates the hole. As DNA bases, or chemical building blocks, pass through the hole, an electronic chip measures changes in electrical current in the membrane and produces data that, when decoded, identifies the sequence of bases that make up a genome.

That’s different from current techniques, in which 200 or 300 continuous bases of DNA are analyzed, Sanghera said. Oxford Nanopore’s machines can read strands of tens of thousands of bases with an accuracy comparable to technology already on the market, he said.

Space Age

“That is some kind of fantastical, space-age thing,” Sanghera said.

The MinION device can only be used once and can’t decode an entire human genome, according to Oxford Nanopore. Users don’t have to amplify DNA to be able to read it, and the sensitivity is about the same as the larger GridION device, Sanghera said.

“This will result in broader adoption of DNA sequencing,” he said. “This allows non-specialist scientists to extract DNA information back in the field. You just need a laptop and software.”

The GridION system, which is about the size of a videocassette recorder, is designed so that researchers who need quick results can add units of cartridges called nodes that speed processing. Using 20 high-end nodes would allow the entire genome to be sequenced in as little as 15 minutes, Oxford Nanopore said.

‘Pregnant Woman’

“Our competitors are like a pregnant woman,” said Zoe McDougall, a company spokeswoman. “It takes nine months to make a baby, and you can’t put nine women on it and get a baby in a month. With our system, you can put nine women on it and make a baby in a month.”

Not all customers want or need such speed, Sanghera said.

“You give flexibility back to the researcher in how they do their experiments,” he said.

Pricing will be “competitive” and will vary, similar to mobile-phone packages tailored to customers’ needs for talk time and data, said Clive Brown, Oxford Nanopore’s chief technology officer.

“There’s no fixed run time on this machine,” Brown said in an interview. “You need pricing elasticity. They all pay same cost per base, but it’s how it’s divided. That’s completely new.”

Life Technologies, based in Carlsbad, California, on Jan. 10 said it is taking orders for its benchtop Ion Proton Sequencer. The machine, available for $149,000, is designed to provide a full transcript of a person’s DNA in a day for $1,000. Illumina, of San Diego, said its HiSeq 2500 will be available in the second half of the year. It didn’t reveal the price.

Potential Buyers

Illumina is the target of a $5.7 billion hostile bid by Roche Holding AG of Basel, Switzerland. Illumina’s board unanimously rejected the offer, calling it “grossly inadequate.” Roche is a sponsor of the conference where Oxford Nanopore presented the data on its machines.

Illumina owns 15 percent of Oxford Nanopore and has a partnership with the U.K. company for a technology called exonuclease sequencing, in which the DNA building blocks are separated by an enzyme and pass individually through a nanopore.

While potential buyers have approached Oxford Nanopore, the company hasn’t pursued any offers, Sanghera said.

“Over the last year, we’ve had various companies express interest in us,” Sanghera said. “We remain focused on our strategy, which is to get this technology to our customers.”

Shareholders

Oxford Nanopore’s shareholders include IP Group Plc, which owns 21.5 percent, hedge-fund manager Lansdowne Partners LP and Invesco Perpetual, the U.K. group of mutual funds. The company also has individual shareholders, including company managers, and employees have stock options.

Oxford Nanopore is valued at about $1 billion, said Charles Weston, a London-based analyst at Numis Securities, which advises IP Group, in a note to investors Feb. 1. Weston based the figures on Oxford Nanopore gaining 25 percent of a market that could grow to $6 billion within five years.

“To get a truly accurate assessment of our valuation, we need to understand what markets we can penetrate,” Sanghera said. “We are not displeased with $1 billion; we feel it could be a lot bigger than that.”

Oxford Nanopore, spun out of University of Oxford in 2005, uses sequencing technologies that were initially based on the research of founder and board member Hagan Bayley, a chemistry professor at the university. The company has built on that science through collaborations with researchers at Harvard University, the University of California Santa Cruz and Boston University, among others, and with internal research, said McDougall, the company spokeswoman.

Early Access

Oxford Nanopore will give early access to a few laboratories to try out the two devices, allowing them to provide feedback and develop applications before the company starts selling the products later this year, Sanghera said.

“The biggest challenge is managing expectations and delivering on the next phase,” Sanghera said. “It feels like you’ve been in a band, and you’ve been doing gigs in grotty little venues, and then you wake up and you’re number one.”

--With assistance from Andrea Gerlin in London. Editors: Phil Serafino, Thomas Mulier

To contact the reporter on this story: Kristen Hallam in London at khallam@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

Read more:
Oxford Nanopore Plans Portable Gene-Sequencing Device This Year

"The reservoir of genetic diversity contained in the oceans' microbial life is a huge potential source of natural products and genes with applications in medicine, food development and bio-energy," says Curtis Suttle, an expert on marine virology and microbiology at the University or British Columbia and member of the panel.

"The question is whether they fall under a regime of 'freedom of the high seas' which allows the discoverer to keep what they find, or under a regime of 'the common heritage of mankind' which would require benefits from the use of genetic resources to be equitably shared amongst countries."

Marine genetic resources discovered in coastal waters are subject to bilateral 'benefit sharing' under international agreements currently being ratified. But no such agreements govern the patenting and commercialization of proteins and genes harvested from international waters.

"Marine genetic resources within national jurisdiction are subject to requirements for benefit sharing under the Nagoya Protocol, and it is time to consider a parallel agreement for areas beyond national jurisdiction," says panelist Marjo Vierros with the United Nations University (UNU). The UNU is the academic arm of the United Nations system.

"Any agreement should include mechanisms to support marine scientific research and invention through creative tools such as patent pools, open access programs, and gene libraries. It should also include measures for tracing the geographic origin of organisms, conservation and sustainable use."

More than 5,000 genes derived from marine organisms have already been associated with patent claims. Ten countries own more than 90% of those claims, including 'marine genes'. Three countries own approximately 70%, a pattern similar to the one observed for human and plant crop genes, according to panelist Sophie Arnaud-Haond, from the Institut Francais de Reserche sur la Mer.

The panel--which alincludes UBC marine chemist Raymond Andersen and researchers from Spain and Germany--cites the need to enhance the capacity of developing countries to participate in this research and invention through capacity development and technology transfer.

Provided by University of British Columbia (news : web)

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'Wild west' approach to claiming the oceans' genetic resources must end: researchers

Student genetic research projects at Concord High School suddenly meant more last week, when genetics researcher and guest speaker Michele Nikoloff explained how similar tests developed at Roche Molecular Diagnostics are used to improve cancer patient treatment.

CHS honors biology teacher Ellen Fasman said as a research leader, Nikoloff's cutting-edge work dovetails with her curriculum.

"We are studying the targeted therapy genetics approach for certain disease genetic disorders, pedigrees and mutations."

Fasman and Dr. Ernie Liu are among the highly credentialed CHS Science Department teachers who brought their classes to the scientist's PowerPoint presentation where the human stories and images seemed to intrigue students most.

Our students loved Dr. Nikoloff's lectures," Liu said. "The most important thing is that my students found out what they have learned in the classroom they can apply to the real world and make a difference for other people's lives."

Nikoloff said, "The field of genetics is rapidly evolving and it is important to prepare students for future developments. Genetics play a role in how drugs are metabolized and enzyme activity varies among different ethnic populations."

In the area of drug metabolism, she relayed to students the story of the unexpected death of a 13 day-old Canadian baby in 2006. The mother, who was subsequently found to be a genetically ultrarapid metabolizer of codeine, was taking

it for post-labor pain relief and breast-feeding the infant.

Metabolized codeine in the breast milk essentially gave the baby a lethal dose of morphine. Since then, measures have been put in place to prevent such incidents from occurring.

Now, physicians can order a genetic test which reveals how an individual patient metabolizes specific drugs.

Nikoloff said only 80 percent of patients respond to analgesic drugs, while less than 60 percent benefit from asthma medications and less than 15 percent of melanoma cancer patients improve with chemotherapy.

"There is a clear need to identify patients likely to respond to medication based on their genetic makeup," Nikoloff said.

Dylan Parisi, CHS honors biology student said, "I found it interesting how rarely treatments such as chemotherapy actually make a difference for patients."

Targeted therapy is based on testing for a patient's genetic markers to determine who is likely to respond to a particular medication. One benefit of these genetic tests is that physicians will not prescribe drugs that are genetically unsuitable. Nikoloff expects targeted therapy will be part of standard health care in the future.

Nikoloff said that treating melanoma patients with a drug targeted to work only in tumors with a specific mutation led to increased survival.

She showed striking images comparing the appearance of a patient with a deadly case of metastasized melanoma (skin cancer) before and after the targeted therapy treatment with the Zelboraf drug.

"Melanoma is the sixth most common cancer in the United States and amongst the most common fatal cancers in young adults, with 8,000 deaths per year," Nikoloff said.

One student lingered after the lecture with questions such as, "Why does genetically targeted drug therapy work better than chemotherapy?"

Nikoloff explained that targeted medication kills only cancer cells, whereas chemotherapy is designed to kill any dividing cells. The severe side-effects of chemotherapy are evidence of the destruction of the body's other rapidly dividing cells.

"Only 50 percent of patients respond to the average anti-depression drugs and sometimes these medications can be harmful," Nikoloff said. "Personalized health care aims to target the right medicine for the right patient at the right time."

That is just what students are doing, according to Fasman.

"Students are learning to research metabolic disorders and working on 80 to 90 genetic disorders. They look for biological markers which can predict a predisposition to illnesses such as cystic fibrosis, diabetes, asthma and other autoimmune diseases."

Fasman initiated the relationship with Roche in Pleasanton and said she appreciated the company allowing Nikoloff to spend the day addressing CHS biology and biotechnology classes.

Nikoloff is a biochemistry graduate from UC-Berkeley, has a doctoral degree from Carnegie Mellon University, and completed postdoctoral training in plant biology at the Carnegie Institution of Washington at Stanford University. She has developed tests for drug metabolism and cancer treatment.

"(Students) get excited about the possibility of experimenting and coming up with new solutions to diseases and global warming," Fasman said. "Students need to know the approaches being used in the manufacture of medicine."

Constantly on the lookout for experts and equipment to enrich her classes in the rapidly changing field of genetics, Fasman said it is challenging for teachers in the current budget-cutting climate.

"Thirty-two students have to take turns using a limited number of expensive pieces of biotechnology equipment. It can range from $100 for lab equipment, to $30,000 to $40,000 for a PCR (polymerase chain reaction "thermocycler")," Fasman said. "We buy the expensive equipment used when it becomes available through industry upgrades."

Contact Dana Guzzetti at dguzzetti10@gmail.com or call 925-202-9292.

Here is the original post:
Concord High School students learn latest in genetics research

By Andrew Zajac and Susan Decker - Fri Feb 17 06:01:01 GMT 2012

Enlarge image Genetic Medicine Advances Shadowed by Regulatory Issues

Gene-sequencing breakthroughs, spawning fast-growing, multibillion-dollar markets for drugs, software and medical tests, are also creating thorny issues over how to regulate commercial use of the human genetic code. Illustration: Rich Clement/Bloomberg

Gene-sequencing breakthroughs, spawning fast-growing, multibillion-dollar markets for drugs, software and medical tests, are also creating thorny issues over how to regulate commercial use of the human genetic code. Illustration: Rich Clement/Bloomberg

Gene-sequencing breakthroughs, spawning a fast-growing, multibillion-dollar market for drugs and medical tests, are also creating thorny questions over how to regulate commercial use of the human genetic code.

Health regulators are fashioning rules for bolstering oversight of laboratory-developed tests, including genetic analysis, that may show whether an individual is predisposed to certain diseases. Congress is determining whether patents on genetic material should be treated differently from other intellectual property.

The agencies, along with the U.S. Supreme Court in cases on genetic patents, are reviewing laws and policies enabling the use of genetic data to tailor treatment for each patient. The changing landscape affects companies including Quest Diagnostics Inc. (DGX), Roche Holding AG and Pfizer Inc. (PFE), the world’s biggest drugmaker.

“The industry is optimistic about the promise of the technology but concerned about challenges on the regulatory and legal fronts,” said Edward Reines, a patent attorney at Weil Gotshal & Manges LLP in Redwood Shores, California.

Genetic tests can indicate a patient’s susceptibility to conditions including breast and ovarian cancer, cystic fibrosis, Huntington’s disease or hemophilia -- and the most promising treatment. The tests alone account for as much as $6 billion in annual sales worldwide that may climb 15 percent a year, estimates Ross Muken, an analyst covering life sciences for Deutsche Bank Securities Inc.

Matching Patients, Products

The use of pairing drugs with diagnostics to help match patients with products rose almost six-fold from 2006 to 2011, according to the Personalized Medicine Coalition, a Washington- based nonprofit focused on educating the public and policy makers on medicine tailored to individuals.

The drugs involved include Pfizer’s Xalkori for a rare form of lung cancer and Basel, Switzerland-based Roche Holding’s Zelboraf for a life-threatening form of skin cancer. Both are accompanied by tests approved by the U.S. Food and Drug Administration to detect gene mutations.

The Supreme Court may say on Feb. 21 whether it will hear two cases capable of changing the landscape for biotechnology companies. In the first, New Brunswick, New Jersey-based Johnson & Johnson (JNJ) is asking the court to overturn a ruling that patent owners must clearly describe what they said they have invented in all patents. The second seeks a review of an appeals court decision upholding the patentability of DNA sequences isolated by Myriad Genetics Inc. (MYGN)

Cancer Risk

In the case involving Salt Lake City-based Myriad, the owner of a test for the hereditary risk of breast and ovarian cancer contends that researchers created a new compound eligible for patent protection by extracting the specific sequence from the long strand of DNA.

Opponents including Ellen Matloff, director of the Yale Cancer Genetic Counseling Program, say Myriad simply identified material that exists in nature.

“We’re all born with these genes,” said Matloff, a plaintiff in the Myriad case. “They didn’t create them. They don’t deserve a patent.”

Patents on individual DNA molecules including Myriad’s are becoming “increasingly irrelevant” because the latest platforms sequence genes en masse to avoid the need to isolate a particular DNA molecule -- and potentially infringe a patent, said James Evans, a professor of genetics and medicine at the University of North Carolina at Chapel Hill.

‘A Disaster’

Evans said he’s more concerned about claims to patent a mental process, such as finding an association between genes and disease risk. The high court is considering the types of diagnostics tests eligible for legal protection.

“What I think would be a disaster would be if the courts were overly permissive,” Evans said. Some patents are “abstract mental processes, and as such not patentable.”

The U.S. Patent and Trademark Office is conducting a Congress-mandated study related to genetic testing and whether special provisions should be created to ensure access to second opinions on tests covered by patents. The first of two hearings was held yesterday, and a report is due in June.

“These are really intense and difficult questions,” said Brenda Jarrell, a patent lawyer with Choate, Hall & Stewart in Boston who specializes in biotechnology. “It’s clearly good to have incentives for companies, institutes or anyone to learn more about the genetic basis of disease and treatments.”

Patent Options

The patent office probably will consider three options: setting more stringent requirements to obtain diagnostic patents, subjecting such patents to shorter terms than normal patents, or requiring patent owners to license their technology to competing labs, Jarrell said.

Patents aren’t the stumbling block to availability, said Hans Sauer, associate general counsel for the Washington-based Biotechnology Industry Organization, said at the hearing.

“One has to strain quite hard to trace existing problems with patient access and utilization of genetic tests back to patents,” said Sauer, who called insurance issues the greatest hindrance.

The patent agency’s historical position that no special rules exist for individual technologies conflicts with social and public policy issues surrounding health care, said Antigone Peyton, a patent lawyer with Cloudigy Law PLLC, of Alexandria, Virginia.

“There’s this intensely personal aspect that you have with diagnostic tests that you don’t have with something like the iPhone,” said Peyton, who co-authored a study on how patents affect access to genetic tests. “There are certain diagnostic patents that have been used to impede the kind of progress we could achieve. But that’s the price we pay by giving rewards to those who innovate.”

FDA Plan

Another source of concern for parts of the genetic medicine field is an FDA plan to oversee lab-developed tests. The policy covers genetic analysis and may affect as many as 30,000 laboratories, according to David Mongillo, former vice president for policy and medical affairs at the Washington-based American Clinical Laboratory Association.

The new, still-unspecified regulatory protocol would apply to tests made by large companies, such as Madison, New Jersey- based Quest and Burlington, North Carolina-based Laboratory Corp. of America Holdings, as well as diagnostics from smaller individual labs.

Regulation Concern

The lab industry says it’s already sufficiently regulated by the Centers for Medicare and Medicaid Services under the Clinical Laboratory Improvement Amendments. Mongillo is concerned that FDA oversight will slow innovation.

“This whole area of genetic and molecular medicine is advancing so rapidly,” Mongillo said. “What these labs can do is rapidly incorporate that new information into the laboratory- developed tests and improve it or better target a patient.” FDA approval still takes time “and the patient suffers,” he said.

It’s bad tests that are causing patients to suffer, said Jeffrey Shuren, director of FDA’s medical device review center.

“We’ve seen plenty of lab-developed tests that are inaccurate,” Shuren told the House Energy and Commerce health subcommittee on Feb. 15.

Some labs copy other companies’ FDA-approved tests, he said, and “who knows if they’re actually any good? You may have tests that are directing patients to get drugs that they shouldn’t, or not get drugs that they should, and that’s a disaster.”

To contact the reporters on this story: Andrew Zajac in Washington at azajac@bloomberg.net; Susan Decker in Washington at sdecker1@bloomberg.net

To contact the editor responsible for this story: Michael Shepard at mshepard7@bloomberg.net

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Patents on Genetic Data Raise Legal Questions on Rights to DNA

16-02-2012 20:19 Many of our patients travel to Guangzhou from all over the world for medical treatment and tourism. China medical tourism can help with becoming a patient, travel arrangements and language assistance. If you want to know more about our services, please browse the web:htttp://www.medicaltourism.hk/ or mail to us: giels-x@medicaltourism.hk firstcare-china@hotmail.com Adult stem cells provide real improvement for cirrhosis patients Breakthrough adult stem cell research has shown that stem cells are able to regenerate and repair damaged or destroyed liver cells. For patients with cirrhosis, this means improved liver function, decreased pain and a significantly improved quality of life. Stem cell therapy offers the safest and most effective treatment alternative for liver cirrhosis and it is quickly becoming a preferred treatment in Asia. China medical tourism offers unique access to the best stem cell therapies available at leading medical facilities. Supporting data and statistics Three out of every four patients treated experienced a significant improvement in their condition following stem cell treatment. The following clinical results were observed: •Improved liver function •Decreased pain •Improved values for liver function, PLT (blood platelet) and blood ammonia You may see improvements during your hospitalization due to neurotrophic factors released during the stem cell transplantation, which stimulate nerve activity; new cells will grow for up to six months after you ...

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China medicdal tourism-- Cirrhosis--Stem cells therapy 1.mp4 - Video

By Kristen Hallam - Fri Feb 17 18:20:49 GMT 2012

Enlarge image Oxford Nanopore Plans Portable Gene-Sequencing Device

Nigel Champan via Bloomberg

Clive G Brown, chief technology officer of Oxford Nanopore Technologies Ltd., displays the company's MinION device.

Clive G Brown, chief technology officer of Oxford Nanopore Technologies Ltd., displays the company's MinION device. Photographer: Nigel Champan via Bloomberg

Oxford Nanopore Technologies Ltd. is entering the gene-sequencing race with a new portable device that will allow people to analyze DNA on the go.

The product, called MinION, is about the size of a USB memory stick, the closely held Oxford, England-based company said today. MinION will be ready for sale in the second half of the year at a cost of less than $900. It’s a smaller version of the GridION device that Oxford Nanopore is developing.

Oxford Nanopore is relying on the two products to spur demand for machines that can decode the building blocks of life, helping to identify new targets for medicines and illuminate crop science. The company is jumping into a market led by Life Technologies Corp. (LIFE) and Illumina Inc. (ILMN), which last month said they’ve built products that can sequence a genome in a day. GridION is designed so that computing equipment can be clustered to sequence an entire human genome in as little as 15 minutes.

“The USB stick is an absolute game-changer,” Oxford Nanopore Chief Executive Officer Gordon Sanghera in a telephone interview. “It’s plug-and-play, on-the-go DNA sequencing.”

Life Technologies fell 4.3 percent to $47.66 at 1:15 p.m. in Nasdaq Stock Market trading after dropping as much as 7 percent, the biggest intraday decline since Oct. 7. Illumina dropped 2.9 percent to $52.39 after falling as much as 4.5 percent.

Tiny Hole

The company presented data on the two products today at the Advances in Genome Biology and Technology conference in Florida. The devices use a novel technique known as strand sequencing, in which an entire string of DNA is guided by an enzyme and passes intact through a tiny hole in a cell membrane one-billionth of a meter wide, like a child sucking spaghetti through his mouth.

The strand-sequencing technique relies on an engineered protein or nanopore that creates the hole. As DNA bases, or chemical building blocks, pass through the hole, an electronic chip measures changes in electrical current in the membrane and produces data that, when decoded, identifies the sequence of bases that make up a genome.

That’s different from current techniques, in which 200 or 300 continuous bases of DNA are analyzed, Sanghera said. Oxford Nanopore’s machines can read strands of tens of thousands of bases with an accuracy comparable to technology already on the market, he said.

Space Age

“That is some kind of fantastical, space-age thing,” Sanghera said.

The MinION device can only be used once and can’t decode an entire human genome, according to Oxford Nanopore. Users don’t have to amplify DNA to be able to read it, and the sensitivity is about the same as the larger GridION device, Sanghera said.

“This will result in broader adoption of DNA sequencing,” he said. “This allows non-specialist scientists to extract DNA information back in the field. You just need a laptop and software.”

The GridION system, which is about the size of a videocassette recorder, is designed so that researchers who need quick results can add units of cartridges called nodes that speed processing. Using 20 high-end nodes would allow the entire genome to be sequenced in as little as 15 minutes, Oxford Nanopore said.

‘Pregnant Woman’

“Our competitors are like a pregnant woman,” said Zoe McDougall, a company spokeswoman. “It takes nine months to make a baby, and you can’t put nine women on it and get a baby in a month. With our system, you can put nine women on it and make a baby in a month.”

Not all customers want or need such speed, Sanghera said.

“You give flexibility back to the researcher in how they do their experiments,” he said.

Pricing will be “competitive” and will vary, similar to mobile-phone packages tailored to customers’ needs for talk time and data, said Clive Brown, Oxford Nanopore’s chief technology officer.

“There’s no fixed run time on this machine,” Brown said in an interview. “You need pricing elasticity. They all pay same cost per base, but it’s how it’s divided. That’s completely new.”

Life Technologies, based in Carlsbad, California, on Jan. 10 said it is taking orders for its benchtop Ion Proton Sequencer. The machine, available for $149,000, is designed to provide a full transcript of a person’s DNA in a day for $1,000. Illumina, of San Diego, said its HiSeq 2500 will be available in the second half of the year. It didn’t reveal the price.

Potential Buyers

Illumina is the target of a $5.7 billion hostile bid by Roche Holding AG (ROG) of Basel, Switzerland. Illumina’s board unanimously rejected the offer, calling it “grossly inadequate.” Roche is a sponsor of the conference where Oxford Nanopore presented the data on its machines.

Illumina owns 15 percent of Oxford Nanopore and has a partnership with the U.K. company for a technology called exonuclease sequencing, in which the DNA building blocks are separated by an enzyme and pass individually through a nanopore.

While potential buyers have approached Oxford Nanopore, the company hasn’t pursued any offers, Sanghera said.

“Over the last year, we’ve had various companies express interest in us,” Sanghera said. “We remain focused on our strategy, which is to get this technology to our customers.”

Shareholders

Oxford Nanopore’s shareholders include IP Group Plc (IPO), which owns 21.5 percent, hedge-fund manager Lansdowne Partners LP and Invesco Perpetual, the U.K. group of mutual funds. The company also has individual shareholders, including company managers, and employees have stock options.

Oxford Nanopore is valued at about $1 billion, said Charles Weston, a London-based analyst at Numis Securities, which advises IP Group, in a note to investors Feb. 1. Weston based the figures on Oxford Nanopore gaining 25 percent of a market that could grow to $6 billion within five years.

“To get a truly accurate assessment of our valuation, we need to understand what markets we can penetrate,” Sanghera said. “We are not displeased with $1 billion; we feel it could be a lot bigger than that.”

Oxford Nanopore, spun out of University of Oxford in 2005, uses sequencing technologies that were initially based on the research of founder and board member Hagan Bayley, a chemistry professor at the university. The company has built on that science through collaborations with researchers at Harvard University, the University of California Santa Cruz and Boston University, among others, and with internal research, said McDougall, the company spokeswoman.

Early Access

Oxford Nanopore will give early access to a few laboratories to try out the two devices, allowing them to provide feedback and develop applications before the company starts selling the products later this year, Sanghera said.

“The biggest challenge is managing expectations and delivering on the next phase,” Sanghera said. “It feels like you’ve been in a band, and you’ve been doing gigs in grotty little venues, and then you wake up and you’re number one.”

To contact the reporter on this story: Kristen Hallam in London at khallam@bloomberg.net

To contact the editor responsible for this story: Phil Serafino at pserafino@bloomberg.net

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Oxford Nanopore Plans Portable Gene-Sequencing Device

A new paper in Nature describes the Drosophila Genetic Reference Panel, or DGRP, which provides the highest-resolution view to date of the genome structure and variation in a population of 192 fruit flies with diverse traits. 

The study was led by Trudy Mackay of North Carolina State University, in collaboration with the Human Genome Sequencing Center at Baylor College of Medicine and David Mittelman of Virginia Tech's Virginia Bioinformatics Institute, as well as a large group of researchers around the world.

"One of the grand challenges of biology is to understand how genetic variants and environmental factors interact to produce variation in complex phenotypes such as height, behaviors, and disease susceptibility within populations. This effort has been stymied by the lack of knowledge of all genetic variants in a population of a genetically tractable model organism. The DGRP sequences provide such a resource," Mackay noted.

It’s been known for a long time that genes often work in concert to produce different effects, or phenotypes. But determining the exact contribution of these genes and genetic changes within them to animal traits remains a key challenge in genetics.

That’s where model organisms like Drosophila melanogaster (the common fruit fly) shine. Using inbred strains of fruit flies in controlled environments, researchers can use whole genome data, which captures genetic changes at the nucleotide level, to better explain why strains exhibit variable traits. The DGRP acts as a “living library” of this information, helping researchers understand both common traits and rare variants. 

Mittelman, with support from the NVIDIA Foundation’s Compute the Cure Award, aided the study by analyzing genetic variation in the Drosophila population.  “To truly exploit whole genome sequencing as a means of determining the basis for traits and disease, it is critical to develop methods for detecting all forms of genetic variation. In this study, we developed a method for measuring tandem repeat variation, which has been shown to modulate gene function, traits, and disease,” said Mittelman. 

A companion paper describing this method has been recently accepted for publication which will enable others to exploit these tools in their research.

The study has far reaching effects that span animal breeding, pesticide development, and personalized medicine.

Provided by Virginia Polytechnic Institute and State University

Continued here:
Genetic 'Rosetta Stone' unveiled in Nature

BOTHELL, Wash.--(BUSINESS WIRE)--

Iverson Genetic Diagnostics, Inc. announced today a partnership agreement with Vanderbilt University under which Iverson receives global exclusive commercialization rights for molecular diagnostics that will help physicians to assess breast cancer risk in women considering hormone replacement therapy during menopause. Research suggests that estrogen metabolites represent one of several determinants of the risk of breast cancer. Specific enzymes regulate the biochemical pathways associated with the metabolism of estrogen. Corresponding genes code for the synthesis of these enzymes. Mutations of these genes are common and have been shown in the work of Fritz Parl, M.D., Ph.D., Philip Crooke, Ph.D., William Dupont, Ph.D., and others to be associated with an increased risk of cancer.

Dr. Sujatha Reddy, M.D., OB/GYN at Premier Care for Women in Atlanta and Medical Correspondent for WXIA, a NBC affiliate in Atlanta, said, “I think I will use this test in my practice for patients who are trying to decide if they should stay on hormone replacement therapy (HRT). If you break down estrogen well, you may be at lower risk for breast cancer and then choose to continue your hormones. We can give people a more individualized therapy based on their own genetic makeup.”

Leroy Hood, M.D., Ph.D., co-founder of the Institute for Systems Biology and a member of Iverson Genetic Diagnostics’ Board of Directors, commented, “The importance of finding gene variants that affect the metabolism of drugs and hormones--hence causing disease--is incredibly important for personalized medicine. This venture between Iverson and Vanderbilt is a wonderful example of a diagnostic test that could significantly improve the health of relevant patients.”

Dean Sproles, CEO of Iverson Genetic Diagnostics, Inc., stated, “We are very pleased to collaborate with Vanderbilt University on this product and look forward to including the new e-Metab GenoSTATTM test in the Women’s Health segment of Iverson’s Physician’s LogicTM portfolio later this year. We are considering additional opportunities to partner with Vanderbilt University in the areas of Women’s Health and Autoimmunity.”

About Iverson Genetic Diagnostics, Inc.

Iverson Genetic Diagnostics, Inc. is a Nevada C corporation with administrative headquarters in Bothell, Washington, and production headquarters in Charleston, South Carolina. Iverson is establishing a recognizable global brand for providing trusted genetic tests and testing services for the emerging market of individualized medicine and genetics-based molecular diagnostics. The company’s mission is to improve patient outcomes through personalized care. Iverson is a fully credentialed laboratory service company focused on providing results within 24 hours for hospitals and physicians. Iverson’s patented technology, Physician’s LogicTM, is our healthcare information resource developed to deploy test results to providers and integrate with various electronic medical record systems in a HIPAA-compliant environment.

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Iverson Genetic Diagnostics, Inc. Announces a Strategic Partnership with Vanderbilt University for the Development and ...

GAITHERSBURG, MD--(Marketwire -02/16/12)- Cytomedix, Inc. (OTC.BB: CMXI.OB - News) (the "Company"), a leading developer of biologically active regenerative therapies for wound care, inflammation and angiogenesis, today announced that Chief Operating Officer Edward L. Field will present a clinical overview of Aldagen's autologous cell therapy technology at two upcoming meetings: The Cell Society's 2nd Annual Clinical Meeting being held February 17-18 at the Coronado Marriott Resort in San Diego; and the 7th Annual New York Stem Cell Summit being held on February 21 at Bridgewaters New York in New York City.

Mr. Field will present during the session, "Commercialization Opportunities with Adult Stem Cell Therapies," on Friday, February 17 from 8:00 a.m. to 10:00 a.m. Pacific time at the Cell Society meeting.

Cell Society International is a non-profit organization dedicated to advancing the clinical application of adult stem cell therapies worldwide. Cell Society's 2nd Annual Clinical Meeting will continue in the tradition established at the 1st Annual Meeting and will offer a unique opportunity for multidisciplinary, international clinical collaboration designed to enhance understanding and thought-provoking insight into treatments and cures for disease and agonizing medical conditions. This year's clinical focus will center on therapies particularly relevant to cardiology, neurology, and orthopedic and plastic surgery.

At the Stem Cell Summit, Mr. Field will present at 2:35 p.m. Eastern time. This meeting showcases more than 30 of the world's leaders in this rapidly evolving industry. The New York Stem Cell Summit brings the future of this dynamic industry to life for investors, industry, practitioners and analysts so they can learn about the investment opportunities in the stem cell marketplace, groundbreaking stem cell products that physicians use today and the growing market potential in terms of revenues.

About Cytomedix, Inc.

Cytomedix, Inc. develops, sells and licenses regenerative biological therapies primarily for wound care, inflammation and angiogenesis. The Company markets the AutoloGel™ System, a device for the production of autologous platelet rich plasma ("PRP") gel for use on a variety of exuding wounds; the Angel® Whole Blood Separation System, a blood processing device and disposable products used for the separation of whole blood into red cells, platelet poor plasma ("PPP") and PRP in surgical settings; and the activAT® Autologous Thrombin Processing Kit, which produces autologous thrombin serum from PPP. The activAT® kit is sold exclusively in Europe and Canada, where it provides a completely autologous, safe alternative to bovine-derived products. On February 8, 2012 Cytomedix announced the acquisition of Aldagen, a biopharmaceutical company developing regenerative cell therapies based on its proprietary ALDH bright cell ("ALDHbr") technology, currently in a Phase 2 trial for the treatment of ischemic stroke. For additional information please visit http://www.cytomedix.com

Safe Harbor Statement
Statements contained in this communication not relating to historical facts are forward-looking statements that are intended to fall within the safe harbor rule for such statements under the Private Securities Litigation Reform Act of 1995. The information contained in the forward-looking statements is inherently uncertain, and Cytomedix' actual results may differ materially due to a number of factors, many of which are beyond Cytomedix' ability to predict or control, including many among others, risks and uncertainties related to the Company's ability to successfully integrate this acquisition, to successfully manage contemplated clinical trials, to manage and address the capital needs, human resource, management, compliance and other challenges of a larger, more complex and intergrated business enterprise, viability and effectiveness of the Company's sales approach and overall marketing strategies, commercial success or acceptance by the medical community, competitive responses, the Company's ability to raise additional capital and to continue as a going concern, and Cytomedix's ability to execute on its strategy to market the AutoloGel™ System as contemplated. To the extent that any statements made here are not historical, these statements are essentially forward-looking. The Company uses words and phrases such as "believes," "forecasted," "projects," "is expected," "remain confident," "will" and/or similar expressions to identify forward-looking statements in this press release. Undue reliance should not be placed on forward-looking information. These forward-looking statements are subject to known and unknown risks and uncertainties that could cause actual events to differ from the forward-looking statements. More information about some of these risks and uncertainties may be found in the reports filed with the Securities and Exchange Commission by Cytomedix, Inc. Cytomedix operates in a highly competitive and rapidly changing business and regulatory environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. Except as is expressly required by the federal securities laws, Cytomedix undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, changed circumstances or future events or for any other reason. Additional risks that could affect our future operating results are more fully described in our U.S. Securities and Exchange Commission filings, including our Annual Report for the year ended December 31, 2010, filed with the SEC and other subsequent filings. These filings are available at http://www.sec.gov.

Originally posted here:
Cytomedix to Showcase Aldagen's Promising Autologous Cell Therapy Technology at Two Regenerative Medicine Meetings