Archive for the ‘Gene Therapy Research’ Category

Close up of laboratory microscope (Matthew Jones)

"Without question, man's knowledge of man is undergoing the greatest revolution since Leonardo. In many ways personalized medicine is already here." - Dr. Francis Collins

That quote, from Dr. Francis Collins, director of the National Institutes of Health, was used at the beginning of a report on genetic testing by UnitedHealth Group's Center for Health Reform & Modernization.

The report, "Personalized Medicine: Trends and prospects for the new science of genetic testing and molecular diagnostics," was released in March.

For the paper, the organization surveyed the public on their familiarity with genetic testing. While 71 percent said they were familiar with the concept, only one in two indicated they were knowledgable about genetic science.

So the Los Angeles News Group spoke with doctors at Cedars-Sinai Medical Center to shed light on this rapidly evolving field of health care.

Genetic testing analyzes a person's genetic material, including genes and biomarkers. While a person's complete DNA can be decoded, a process called whole genome sequencing, researchers don't know how to interpret all of the information quite yet. Currently, tests can be used to detect 2,500 conditions, according to UnitedHealth.

"The whole genetic testing story is linked to an entire paradigm in medicine that is evolving, and that is personalized medicine," says Dr. Mahul Amin, chairman of Pathology and Laboratory Medicine at

Amin's research focuses on uncovering biomarkers for cancer - particularly of the prostate, bladder, kidney and testis - that will allow for personalized treatment of patients with these diseases.

A biomarker is a biochemical, genetic or molecular characteristic that acts as an indicator of a particular biological condition.

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Advances in genetic testing allow for more personalized medical treatments

Seattle Genetics has been ripping higher, and one investor is milking income from the trend.

optionMONSTER's tracking systems detected a surge of activity in the August 22.50 puts, which were sold for $0.80, and the July 20 puts, which were bought for $0.15. An even 1,700 traded in each, but volume was below open interest in the July contracts.

The investor apparently sold those at an earlier date to earn income and yesterday adjusted the trade to collect an additional $0.65. He or she also took on more risk by agreeing to stay in the trade for another month but raised by $2 the price at which he or she would be forced to buy shares.

SGEN rose 2.53 percent to $25.57 yesterday and is up 24 percent in the last month. Most of those gains have come after the company announced positive Phase 1 drug-trial data for its prospective cancer compound ASG-5ME.

Selling puts is a common strategy when investors like a stock but don't want to spend capital up front to buy shares. If their bullish outlook is correct and the stock does not fall, they can continue to collect income every month by rolling the contracts forward. (See our Education section for more strategies that turn time into money .)

Overall option volume was more than 7 times greater than average in the session.

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Seattle Genetics draws income trade

Forget patches: gene therapy could suppress cigarette cravings by preventing the brain from receiving nicotine. The treatment is effective in mice, but with gene therapy still not fully tested in people, human trials and treatments are a long way off.

For drug users who really can't quit, vaccination might one day be an option, and several groups have attempted to develop such treatments.

But nicotine vaccines have mostly flopped. This is because nicotine is a very small molecule, so the immune system has difficulty recognising the drug and making antibodies that bind it. Physicians can inject antibodies directly into a patient, but this treatment quickly becomes expensive because the antibodies don't last long.

Ronald Crystal of Weill Cornell Medical College in New York and his team decided to bypass that problem by putting the gene for a nicotine antibody right into the body.

They selected the strongest antibody against nicotine from a mouse and isolated the gene that produced it. They then placed this gene into a carrier called adeno-associated virus (AAV), which is widely used for gene therapy.

When the researchers injected the virus and its cargo into nicotine-addicted mice, the rodents' livers took up the virus, began making antibodies and pumped them into the bloodstream. The researchers injected two cigarettes' worth of nicotine into AAV-infected mice. The antibodies were able to bind 83 per cent of the drug before it reached the brain.

Without their drug, the mice's behaviour changed. Nicotine usually causes mice to "chill out", Crystal says, but the researchers found that the treated mice stayed active and their heart rates stayed normal when they received nicotine.

Eighteen weeks later, the mice's livers were still making the antibody, suggesting that the therapy might render nicotine useless to smokers for long periods.

Jude Samulski at the University of North Carolina at Chapel Hill, who was part of the team that developed AAV as a gene therapy vector, says he's "ecstatic" that the vector has come so far. He calls the research "a gorgeous piece of work" that has "leapfrogged" the difficulties faced by vaccines.

But he has doubts about whether gene therapy is well-tested enough to be used to treat nicotine addiction. So far, AAV has been clinically tested in people with HIV or terminal cancer where potential benefits far outweigh the risks. "It's ahead of its time. In 10 years there may be enough safety data," he says. "Quitting smoking might be easier."

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Gene therapy curbs nicotine addiction in mice

By Elizabeth Lopatto - 2012-06-27T18:00:00Z

An experimental vaccine againstnicotine, delivered using gene therapy, prevents the substance from reaching the brain and may make quitting easier for smokers, a study using mice indicates.

A single dose of vaccine allowed the liver to produce antibodies that stopped most of the nicotine from getting to the brain, according to a study in the journal Science Translational Medicine. The concentration of nicotine in the brains of treated mice was just 15 percent of that in untreated ones.

Of the more than 4,000 chemicals in cigarette smoke, it is nicotine that leads to addiction, the researchers wrote. Keeping the substance away from the brain might stymie nicotines addictive power by preventing smokers from enjoying their cigarettes, giving them no incentive to relapse, said Ronald Crystal, one of the studys researchers.

This looks really terrific if youre a mouse, but the caveat is that they arent small humans, said Crystal, the chairman of genetic medicine at Weill Cornell Medical College in New York, in a telephone interview.

The gene therapy delivers the vaccine to the liver using a virus engineered not to be harmful. The gene sequence for the antibodies is inserted into liver cells, which then begin to create antibodies to nicotine.

The antibody is floating around like Pac-Man in the blood, Crystal said. If you give the nicotine and the anti- nicotine gobbles it up, it doesnt reach the brain.

The idea of vaccines against nicotine has emerged before, in the form of injections used to trigger an immune response. Those methods proved ineffective, according to the researchers. They turned to gene therapy to trigger production of antibodies.

About 20 percent of U.S. adults are smokers, and most relapse shortly after quitting.

We dont have very effective therapies, Crystal said. The problem is even with the drugs we have now, 70 percent of people go back to smoking within 6 months of trying to quit.

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Gene Therapy Against Nicotine May Someday Help Smokers Quit

26-06-2012 15:56 Ain't nobody fuckin wit dis young nigga!!!DGB shit!!!Young J

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Cell Therapy Freestyle - Video

Optimal stem cell therapy delivery to damaged areas of the heart after myocardial infarction has been hampered by inefficient homing of cells to the damaged site. However, using rat models, researchers in France have used a magnet to guide cells loaded with iron oxide nanoparticles to key sites, enhancing the myocardial retention of intravascularly delivered endothelial progenitor cells.

The study is published in a recent issue of Cell Transplantation (21:4), now freely available online.

"Cell therapy is a promising approach to myocardial regeneration and neovascularization, but currently suffers from the inefficient homing of cells after intracavitary infusion," said Dr. Philippe Menasche of the INSERM U633 Laboratory of Surgical Research in Paris. "Our study was aimed at improving and controlling homing by loading human cord-blood-derived endothelial progenitor cells (EPCs) for transplant with iron oxide nanoparticles in order to better position and retain them in the hearts of myocardial-injured test rats by using a subcutaneously implanted magnet."

The researchers found that the cells were sufficiently magnetic to be able to be remotely manipulated by a magnet subsequent to implantation.

According to the researchers, an objective assessment of the technique to enhance the homing of circulating stem cells is the ability to track their fate in vivo. This was accomplished by visualization with MRI.

"We found a good correlation between MRI non-invasive follow-up of the injected cells and immunofluoresence or quantitative PCR data," said Dr. Menasche. The researchers concluded that further studies were needed to follow cell homing at later time points. They noted that the magnitude of homing they experienced may have been reduced by the relatively small number of cells used, owing to their large size and the subsequent risk of coronary thrombosis.

"In a rat model of myocardial infarction, this pilot study suggested homing of circulating stem cells can be improved by magnetic targeting and warrants additional benchwork to confirm the validity of concept," said Dr. Menasche. "There is also a need to optimize the parameters of targeting and assess the relevance of this approach in a clinically relevant large animal model."

"This study highlights the use of magnets to target transplanted cells to specific sites which could increase their regenerative impact. Factors to still be extensively tested include confirming the safety of the cells containing the magnetic particles and whether this process alters the cell's abilities" said Dr. Amit N. Patel, director of cardiovascular regenerative medicine at the University of Utah and section editor for Cell Transplantation.

More information: Chaudeurge, A.; Wilhelm, C.; Chen-Tournoux, A.; Farahmand, P.; Bellamy, V.; Autret, G.; Mnager, C.; Hagge, A.; Larghro, J.; Gazeau, F.; Clment, O.; Menasch, P. Can Magnetic Targeting of Magnetically Labeled Circulating Cells Optimize Intramyocardial Cell Retention? Cell Transplant. 21 (4):679-691; 2012.

Journal reference: Cell Transplantation

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Magnet helps target transplanted iron-loaded cells to key areas of heart

Public release date: 26-Jun-2012 [ | E-mail | Share ]

Contact: Mary Ellen Peacock maryellen.peacock@nationwidechildrens.org 614-355-0495 Nationwide Children's Hospital

Scientists now have clues to how a gene mutation discovered in families affected with congenital heart disease leads to underdevelopment of the walls that separate the heart into four chambers. A Nationwide Children's Hospital study appearing in PLoS Genetics suggests that abnormal development of heart cells during embryogenesis may be to blame.

When babies are born with a hole in their heart (either between the upper or lower chambers), they have a septal defect, the most common form of congenital heart disease. Although it's not clear what causes all septal defects, genetic studies primarily utilizing large families have led to the discovery of several causative genes.

Vidu Garg, MD, the study's lead author, previously reported that a single nucleotide change in the GATA4 gene in humans causes atrial and ventricular septal defects along with pulmonary valve stenosis. In mice, the GATA4 gene has been shown to be necessary for normal heart development and its deletion leads to abnormal heart development.

"While GATA4 has been shown to be important for several critical processes during early heart formation, the mechanism for the heart malformations found in humans with the mutation we previously reported is not well understood," said Dr. Garg, a pediatric cardiologist in The Heart Center and principal investigator in the Center for Cardiovascular and Pulmonary Research at The Research Institute at Nationwide Children's Hospital.

To better characterize the mutation, Dr. Garg and colleagues generated a mouse model harboring the same human disease-causing mutation. They saw heart abnormalities in the mice that were consistent with those seen in humans with GATA4 mutations. Upon further examination, they found that the mutant protein leads to functional deficits in the ability for heart cells to increase in number during embryonic development.

"Our findings suggest that cardiomyocyte proliferation deficits could be a mechanism for the septal defects seen in this mouse model and may contribute to septal defects in humans with mutations in GATA4," said Dr. Garg, also a faculty member at The Ohio State University College of Medicine. "This mouse model will be valuable in studying how septation and heart valve defects arise and serve as a useful tool to study the impact of environmental factors on GATA4 functions during heart development."

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New mouse model helps explain gene discovery in congenital heart disease

On Wednesday, the Street was finally able to initiate coverage on Facebook, 40 days after the IPO.

And it seems widely followed Piper Jaffray analyst Gene Munster may have found a new object of affection.

During a live interview on CNBCs Fast Money Halftime Report he sounded almost as enthusiastic about Facebook

Although Munster concedes that in the near-term Facebook may be facing headwinds, he tells us that Given what theyre doing, to even think about the next 6 months is missing the whole point, he says.

Ahead of the broadcast Munster told us there are a few big reasons investors should own Facebook.

They are: - Trades significantly below companys long term EBITDA - Extremely unique property online

But aside for the reasons mentioned above - Munster believes there's another upside catalyst and it's a doozy. In fact, it's the same catalyst famed venture capitalist Roger McNamee told us back on May 18th, the day of the IPO. Facebook is about to change the way we shop.

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In case youre curious heres how the Street rates Facebook:

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Link:
Why You Should Own Facebook Now: Gene Munster

Newswise An international team including scientists from the University of Saskatchewan-Saskatoon Health Region and University of British Columbia, with the help of Saskatchewan Mennonite families, has identified an abnormal gene which leads to Parkinsons disease.

This discovery paves the way for further research to determine the nature of brain abnormalities which this gene defect produces, says Dr. Ali Rajput, a world expert in Parkinsons disease who has been studying the disease for 45 years and working with the main family in the study since 1983.

It also promises to help us find ways to detect Parkinsons disease early, and to develop drugs which will one day halt the progression of the disease.

The abnormal gene is a mutated version of a gene called DNAJC13, identified by UBC medical genetics professor Matthew Farrer, who led the study.

Thirteen of 57 members of one extended Saskatchewan family in the study had been previously diagnosed with Parkinsons disease. Three other single cases from Saskatchewan and one family from British Columbia were also found to have the same mutation. All were of Mennonite background, a Christian group who share Dutch-German-Russian ancestry.

The findings were presented last week to the more than 5,000 delegates at the 16th International Congress of Parkinsons Disease and Movement Disorders in Dublin, Ireland.

Rajput and his son, fellow neurologist and researcher Alex Rajput, are long-time collaborators of Farrer. The research drew on the Rajputs work over the past four decades. The research team also includes scientists from McGill University, the Mayo Clinic in Florida, and St. Olavs Hospital in Norway.

A key contribution is the Rajputs collection of more than 500 brains and nearly 2,200 blood samples from Parkinsons patients. Farrer explains that confirmation of the genes linkage with Parkinsons disease required DNA samples from thousands of patients with the disease and healthy individuals. He adds that the contributions of the Saskatchewan Mennonite family, who have asked to remain anonymous, were critical.

A breakthrough like this would not be possible without their involvement and support. They gave up considerable time, contributed clinical information, donated blood samples, participated in PET imaging studies and on more than one occasion following the death of a family member donated brain samples, says Farrer, who holds the Canada Excellence Research Chair in Neurogenetics and Translational Neuroscience.

The whole-hearted and unselfish commitment of this family is remarkable, Rajput says. They went out of their way in every conceivable manner to help solve this mystery. We, on behalf of all the Parkinsons disease patients in this province, Canada, and around the world, are grateful to them for making this discovery possible.

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Team Identifies Parkinson's Disease Gene with Help of Saskatchewan Mennonite Families

Several tests are now available that can analyse fetal DNA present in a pregnant woman's blood.

BSIP/PHOTOTAKE

Genetic tests that analyse fetal DNA from a pregnant woman's blood are arriving in a rush, giving parents powerful tools for gleaning information about their unborn offspring. Three companies have launched versions of such tests in the past 12 months, and a fourth plans to do so later this year.

But the commercialization of these tests has brought a legal battle that could not only affect corporate profits, but also limit which patients will be able to access the tests and under what terms. The tangle of lawsuits may also offer a taste of future conflicts in the rapidly growing medical-genomics industry.

If a single company has a monopoly on the market, it will essentially be able to dictate the standard of care and the quality of care, says Mildred Cho, a bioethicist at the Stanford University School of Medicine in California.

The four firms are all based in California Sequenom in San Diego, Ariosa Diagnostics in San Jose, and Verinata Health and Natera, both in Redwood City and use similar techniques to identify fetal DNA in maternal blood samples. The tests can spot genetic abnormalities, such as those that cause Down's syndrome, as early as ten weeks after conception several weeks sooner than tests already in use. In studies of women at high risk of carrying offspring with Down's syndrome, the tests also produced fewer false positives.

Patents are at the core of the conflict (see 'Blood feuds'). Sequenom licensed the method for detection of cell-free fetal DNA in a mother's bloodstream in 2005, and it now says that other companies are infringing this patent.

A spate of prenatal DNA tests has brought with it a host of legal disputes.

14 OCTOBER 2005

Sequenom licenses a patent for non-invasive prenatal diagnosis.

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Fetal tests spur legal battle

Public release date: 27-Jun-2012 [ | E-mail | Share ]

Contact: Brian Lin brian.lin@ubc.ca 604-822-2234 University of British Columbia

An international team led by human genetic researchers at the University of British Columbia and Vancouver Coastal Health has identified the latest gene associated with typical late-onset Lewy body Parkinson's disease (PD), with the help of a Canadian Mennonite family of Dutch-German-Russian ancestry.

Twelve of the 57 members of the Saskatchewan family who participated in the study had previously been diagnosed with PD.

UBC Medical Genetics Prof. Matthew Farrer, who led the research, notes that unequivocal confirmation of the gene's linkage with PD required DNA samples from thousands of patients with PD and healthy individuals. He refers to the new discovery as the "missing link," as it helps to unify past genetic discoveries in PD.

"A breakthrough like this would not be possible without the involvement and support of the Saskatchewan Mennonite family who gave up considerable time, contributed clinical information, donated blood samples, participated in PET imaging studies and, on more than one occasion following the death of an individual, donated brain samples," says Farrer, Canada Excellence Research Chair in Neurogenetics and Translational Neuroscience and the Dr. Donald Rix BC Leadership Chair in Genetic Medicine.

"We are forever indebted to their generosity and contribution to better understanding and ultimately finding a cure for this debilitating disease."

The mutation, in a gene called DNAJC13, was discovered using massively parallel DNA sequencing. Conclusive evidence came from the identification of the gene mutation in several other families across many Canadian provinces, including British Columbia.

"This discovery is not only significant for researchers, but also for those families carrying this genetic mutation and afflicted with this disease in that it offers hope that something good might yet result from their suffering," says Bruce Guenther, President of the Mennonite Brethren Biblical Seminary Canada, a community leader and spokesperson for the family that participated in the study.

"The family involved is very grateful for the research team's respectful, collaborative and sensitive approach, and we hope that this enables the discovery of more effective treatments, and hopefully eventually a cure."

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Parkinson's disease gene identified with help of Mennonite family: UBC-VCH research

COLORADO SPRINGS, Colo.--(BUSINESS WIRE)--

HemoGenix announced today that FDA CBER has given HemoGenix its first Master File Number for an in vitro blood stem cell potency, quality and release assay (HALO-96 PQR) (1)for cellular therapy products(2)used for stem cell transplantation purposes. HALO-96 PQR is the first commercially available stem cell potency assay for cellular therapy products. It incorporates the most sensitive readout available to measure changes in the cells energy source (ATP) as a function of the potential for stem cells to proliferate. Potency and quality of stem cell therapeutic products are required to be measured prior to use to help predict the engraftment of the cells in the patient. At the present time, tests such as cell number, viability and a stem cell marker called CD34 are routinely used. However, none of these tests specifically measure stem cells and none determine the stem cell biological activity required for a potency assay. The only cell functionality test presently used in this field, especially for umbilical cord blood transplantation, is the colony-forming unit (CFU) assay, which is subjective, non-validated and has been used since the early 1970s. HALO-96 PQR changes this paradigm. It is particularly needed in the umbilical cord blood stem cell transplantation field by providing an application-specific test incorporating all of the compliance characteristics required not only by regulatory agencies(3) and standards organizations, but also the cord blood community(4).

Stem cell potency is one of the most important parameters necessary for any therapeutic product, especially stem cells. Without it, the dose cannot be defined and the transplantation physician has no indication as to whether the product will engraft in the patient. The number of cord blood units collected and stored and the number of cord blood stem cell transplantations have increased exponentially over the last 12 years. During this time, significant advancements have been made in pre- and post stem cell transplantation procedures. Yet the tests used during the preparation and processing of the cells have remained unchanged and do not even measure the biological functionality of the stem cells being transplanted. Indeed, the standards organizations responsible for applying regulatory guidance to the community have so far failed to allow any new and alternative assays to be used during cord blood processing. HALO-96 PQR is the first test that actually quantitatively characterizes and defines the stem cells in cord blood, mobilized peripheral blood or bone marrow as high quality and potent active ingredients for release prior to transplantation. Presently, approximately 20% engraftment failure is encountered in cord blood transplantation. HALO-96 PQR could help reduce the risk of engraftment failure by providing valuable and time-sensitive information on the stem cells prior to use. HALO-96 PQR complies with the guidelines not only with the cord blood community, but also with regulatory agencies thereby providing a benefit to both the stem cell transplantation center and the patient, said Ivan Rich, Founder and CEO of HemoGenix (www.hemogenix.com).

About HemoGenix, Inc.

HemoGenix is a privately held Contract Research Service and Assay Development Laboratory based in Colorado Springs, Colorado. Specializing in predictive in vitro stem cell toxicity testing, HemoGenix provides its services to small, medium and many of the largest biopharmaceutical companies. HemoGenix has developed several assays for stem cell therapy and regenerative medicine applications. These and other patented and proprietary assays are manufactured and produced in Colorado Springs and sold worldwide. HemoGenix has been responsible for changing the paradigm and bringing in vitro stem cell hemotoxicity testing into the 21st century. With HALO-96 PQR the company is now also changing the paradigm to become a leader in stem cell therapy assays. To this end, HemoGenix is a member of the Alliance for Regenerative Medicine and working with other companies to decrease risk and improve safety for the patient.

Literature Cited

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HemoGenix® FDA Master File to Measure Blood Stem Cell Potency for Cellular Therapy Products:

Capt. Gene Flipse, president of Conscious Breath Adventures, presents Into the Wild with Dolphins & Whales from 6 to 7 p.m. on Wednesday, June 27 at the Rookery Bay Environmental Learning Center, 300 Tower Road in Naples. Doors open at 5:30 p.m. for a wine and cheese reception with the speaker. The cost is $8 for Friends of Rookery Bay members and $10 for non-members. Registration is suggested at rookerybay.org/upcoming-events. For more information, call 417-6310 x401.

Flipse will introduce guests to some of the most iconic marine species of our sub-tropical corner of the North Atlantic. Join him on a magical and visually stunning journey into their watery realm to learn how to meet them for yourself and the actions we can take to ensure these ocean sentinels are protected for years to come.

Flipse was born in Miami and grew up on the waters of Biscayne Bay, the Keys, the Ten Thousand Islands and the Bahamas. A United States Coast Guard licensed captain for 27 years, Flipse worked for more than 15 years captaining liveaboard dive boats operating between Florida, the Bahamas and the Dominican Republic. During these years, he had his first interactions with wild dolphins and whales in their natural environment. Over the course of his career, he has had the honor to work with world-class explorers, researchers, environmentalists, conservationists, photographers and documentary and feature film makers, guiding them to experience the thrill of swimming with dolphins and whales themselves. His work has also taken him to California, Japan, Australia and Tonga.

The series continues on July 11 with Denise Boyd, research associate for the Florida Fish and Wildlife Conservation Commission Marine Mammal Program, discussing Helping Stranded Marine Mammals.

On July 25, Wayne Hasson, president of Oceans for Youth Foundation and co-founder of Aggressor Fleet, presents Fascinating Humpback Whale Facts. The series concludes on Aug. 15 when Kati Therriault, a manatee research biologist for the Florida Fish and Wildlife Conservation Commission, presents Manatee Response, Recovery and Research.

This story is contributed by a member of the Naples community and is neither endorsed nor affiliated with Naples Daily News

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Gene Flipse is next lecturer in Rookery Bay’s summer series

MAYNARD, Mass.--(BUSINESS WIRE)--

Allegro Diagnostics today announced the formation of its Clinical and Scientific Advisory Board. Allegro has developed a molecular testing platform that utilizes gene expression of normal epithelial cells in the respiratory tract to detect early signs of lung cancer.

Our advisory board is comprised of some of the most respected and prolific clinicians, researchers and pioneers in the fields of pulmonary medicine, lung cancer and cancer diagnostics, said Michael D. Webb, President and Chief Executive Officer of Allegro Diagnostics. These individuals will play a central role in advising Allegro on its research and development efforts, as well as on the product development strategy for the BronchoGen genomic test, which is approaching commercialization.

The members of the advisory board are:

About the Allegro Platform

Allegro Diagnostics molecular testing platform utilizes gene expression of normal epithelial cells in the respiratory tract to detect early signs of lung cancer. The field of injury principle on which the platform is based refers to the common molecular response that occurs throughout the respiratory tract in current and former smokers with lung cancer. These changes can be detected in a gene expression signature from non-malignant airway cells and indicate the presence of malignancy remotely in the lung. Allegro has applied this platform to generate multiple product candidates.

About Allegro Diagnostics

Allegro Diagnostics is a molecular diagnostics company focused on the development and commercialization of innovative genomic tests for the diagnosis, staging and informed treatment of lung cancer and other lung diseases. Allegro has developed a molecular testing platform that utilizes a genomic biomarker to detect early signs of lung cancer in current and former smokers. The companys lead product is the BronchoGen genomic test for use in combination with standard bronchoscopy for the diagnosis of lung cancer. http://www.allegrodx.com

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Allegro Diagnostics Appoints Clinical and Scientific Advisory Board Comprised of Experts in Pulmonology, Lung Cancer ...

I have argued that natural genetic engineering is the real creative process in evolutionary innovation. A central but undocumented feature of my argument is that cells can coordinate separate DNA-change events to produce functional new genome structures. How can experimentalists test this argument?

The experiments will probably involve microorganisms, such as bacteria or yeast. A standard procedure for measuring microbial DNA change (mutation) is to place the microbes in a petri dish where they cannot grow into colonies, count the number of cells deposited, incubate them for a period of time, and count the number of colonies that appear. Each colony arose from a mutational event that overcame whatever prevented growth (e.g., inability to utilize the nutrients provided or to synthesize a needed biochemical). The ratio of colonies to cells placed on the growth medium is the mutant frequency. We can measure how various treatments, such as UV irradiation, change this frequency.

Mutation experiments generally look for changes at a single location in the genome. With modern DNA-sequencing technology, the precise changes are easy to identify. Colonies typically appear two to three days after the appropriate DNA change has occurred. In most cases studied, suitable mutations occur in the population prior to plating. Examining the petri dishes after two or three days indicates the frequency of preexisting mutations.

Longer incubation of the selection plates often produces a large increase in the number of colonies. This indicates that mutations continue to occur under selection conditions. By counting these colonies and analyzing the population dynamics of the selected bacteria, we can determine whether selection affects the process of genome change.

When selection significantly stimulates mutations above prior levels, the process is called "adaptive mutation." Molecular geneticists agree that adaptive mutation (observed in different microorganisms) occurs when selective stress triggers natural genetic engineering activities that carry out DNA changes allowing mutated cells to form colonies.

In some cases, we know the consensus interpretation is correct. Together with my colleague Genevieve Maenhaut-Michel, I confirmed this. We studied an experimental situation where the required DNA change (a special type of coding sequence fusion) was never detected during normal growth but increased at least 100,000-fold after selection.

Other groups confirmed selection stress triggering natural genetic engineering by detecting evidence of "induced hypermutation" at various locations throughout the genome and by direct measurement of mutator function.

It is likely that more complex changes can be triggered by selection conditions. My colleague Bernhard Hauer worked for many years at the large German chemical company BASF. In order to produce certain specialty biochemicals, BASF used microbes. But often the good producer organisms would only grow on expensive nutrients. So Bernhard simply plated them on medium containing economic nutrients, waited for a month or so, and harvested the late-appearing colonies. Unfortunately, this was before the days of rapid sequencing, and we do not know what kinds of DNA changes occurred in the long time before the colonies finally appeared.

In order to look for coordinated natural genetic engineering at multiple locations, one approach is to repeat what Bernhard did but start with well-defined strains. We know that coding sequences that lack transcription signals can be activated by the upstream insertion of mobile elements in bacteria and yeast.

The strategy is to engineer strains that could only grow when multiple mobile element insertions activated several different coding sequences. For example, these sequences might encode proteins needed at various steps of a metabolic pathway (for nutrient utilization or for biosynthesis). Selection for activation of all the sequences together simply involves placing the microbes on a medium where the whole pathway is essential for growth, and then waiting for colonies to appear.

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James A. Shapiro: Experimental Evolution: How Can We Watch Natural Genetic Engineering in Real Time?

Prenatal exposure to bisphenol A -- a compound bearing similarities to the hormone estrogen, which is found in a lot of plastics -- meant lasting genetic changes for female mice when they reached puberty, according to new research that reinforces concerns about the link between BPA and female reproductive disorders.

Yale University School of Medicine researchers presented the data Tuesday at a meeting of The Endocrine Society in Houston, Texas. The research has not yet appeared in a peer-reviewed journal.

Before the mice reached puberty, the Yale team didn't see much difference in the gene expression patterns of BPA-exposed mice and control mice.

But after the mice reached puberty, BPA-exposed mice showed alterations in how much of a gene's product was produced for 365 separate genes. In 208 of those genes, the researchers saw unusual patterns of DNA methylation - a chemical process that regulates how the gene is expressed. Of those 208 genes, at least 14 are known to play roles in the mouse's response to estrogen.

Other studies have linked BPA's estrogen-like characteristic to breast cancer and other disorders with roots in abnormal sensitivity to estrogen, according to the researchers.

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Many major manufacturers have already stopped using BPA in the production of baby bottles and other products, and the U.S. Food and Drug Administration says it is working to develop BPA alternatives for the linings of infant formula cans.

"BPA exposure in utero appears to program uterine estrogen responsiveness in adulthood," lead author Hugh Taylor said in a statement. "Pregnant women should minimize BPA exposure."

Link:
BPA Exposure Alters Genetic Patterns In Pubescent Mice: Study

ALISO VIEJO, Calif.--(BUSINESS WIRE)--

Ambry Genetics, a global leader in genetics with a focus on clinical diagnostics and genomic services, is sponsoring the Clinical Diagnostics Conference 2012, September 27-29 at the St. Regis Monarch Beach Resort. The event will feature a keynote speech by Kevin Davies, Ph.D., Editor-in-Chief of Bio-IT World and author of The $1,000 Genome: The Revolution in DNA Sequencing and the New Era of Personalized Medicine (Free Press, 2010), as well as a number of industry leaders and surprise guests.

As the name implies, this conference will take a close look at cutting-edge developments in clinical diagnostics and related fields, as well as insights on what comes next, from some of the leaders in the field, commented Charles Dunlop, chief executive officer of Ambry Genetics. This is the first of what we hope will become an annual event, and the speaker roster is growing fast with boldface names from around the world. We invite clinicians and anyone else with an interest in clinical diagnostics, genomics and genetics to join us at the beautiful St. Regis Monarch Beach for two days of enrichment, networking and socializing.

Conference highlights:

About Ambry Genetics

Ambry Genetics is a College of American Pathologists (CAP)-accredited and Clinical Laboratory Improvement Amendments (CLIA)-certified commercial clinical laboratory with headquarters in Aliso Viejo, Orange County, Calif. Since its founding in 1999, it has become a leader in providing genetic services focused on clinical diagnostics and genomic services, particularly in sequencing and array services. Ambry has established a reputation for unparalleled service and has been at the forefront of applying new technologies to the clinical molecular diagnostics market and to the advancement of disease research. To learn more about testing and services available through Ambry Genetics, visit http://www.ambrygen.com.

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Ambry Genetics to Sponsor The Clinical Diagnostics Conference 2012: What’s Next & What’s Now

ScienceDaily (June 26, 2012) In the brains of humans and non-human primates, over 100 billion nerve cells build up complicated neural circuits and produce higher brain functions. When an attempt is made to perform gene therapy for neurological diseases like Parkinson's disease, it is necessary to specify a responsible neural circuit out of many complicated circuits.Until now, however, it was difficult to introduce a target gene into this particular circuit selectively.

The collaborative research group consisting of Professor Masahiko Takada from Primate Research Institute, Kyoto University, Professor Atsushi Nambu from National Institute for Physiological Sciences, National Institutes of Natural Sciences, and Professor Kazuto KOBAYASHI from Fukushima Medical University School of Medicine have now developed a gene transfer technique that can "eliminate"a specific neural circuit in non-human primates for the first time.

They applied this technique to the basal ganglia, the brain region that is affected in movement disorders such as Parkinson's disease, and successfully eliminated a particular circuit selectively to elucidate its functional role. This technique can be applied to gene therapy for various neurological diseases in humans. This research achievement was supported by the Strategic Research Program of Brain Sciences by MEXT of Japan.

The research group developed a special viral vector, NeuRet-IL-2R alpha-GFP viral vector, expressing human interleukin type 2 alpha receptor, which the cell death inducer immunotoxin binds. Nerve cells transfected with this viral vector cause cell death by immunotoxin. First, the research group injected the viral vector into the subthalamic nucleus that is a component of the basal ganglia. Then, they injected immunotoxin into the motor cortex, an area of the cerebral cortex that controls movement, and succeed in selective elimination of the "hyperdirect pathway" that is one of the major circuits connecting the motor cortex to the basal ganglia. As a result, they have discovered that neuronal excitation observed at the early stage occurs through this hyperdirect pathway when motor information derived from the cortex enters the basal ganglia.

Professors Takada and Nambu expect that this gene transfer technique enables us to elucidate higher brain functions in primates and to develop primate models of various psychiatric/neurological disorders and their potential treatments including gene therapy. They think that this should provide novel advances in the field of neuroscience research that originate from Japan.

This research was supported by the Strategic Research Program of Brain Sciences by MEXT of Japan.

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The above story is reprinted from materials provided by National Institute for Physiological Sciences.

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Transgenic technique 'eliminates' a specific neural circuit in brain of primates

25-06-2012 00:49 ProGenaCell physicians provide advanced cellular therapy to patients suffering from all known degenerative diseases. For over 70 years cell therapy has been used safely and effectively in such diverse regions as the European Union, former USSR, Republic of China, Middle East, Pacific Rim, Central and South America, Baja California and more recently the United States under select clinical trials. ProGenaCell provides patients with autologous stem cells (patient's own cells), adult progenitor xenocells, and organ extracts & growth factors. These "cellular products" are delivered to physicians who have been approved to prescribe and administer cellular therapies to patients in need. All cellular products are lawfully manufactured, and regulated under strict European Union guidelines. Visit us:

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Dr. Ulrich Friedrichson, MD,PHD - Cell Therapy Introduction - Video

NEW YORK, June 25, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NYSE MKT:NBS) ("NeoStem" or the "Company"), a cell therapy company, today announced that it has been awarded a two year grant totaling $595,252 for the "Development of Human, Autologous, Pluripotent Very Small Embryonic Like (VSELs) Stem Cells as a Countermeasure to Radiation Threat" from the National Institute of Allergy and Infectious Diseases (NIAID), a division of the National Institutes of Health (NIH). This peer reviewed grant was awarded to support research to be headed by Denis O. Rodgerson, Ph.D., Director of Stem Cell Science for NeoStem and Mariusz Ratajczak, M.D., Ph.D., who is the head of the Stem Cell Biology Program at the James Graham Brown Cancer Center at the University of Louisville and co-inventor of VSELTM Technology.

This award will fund studies to investigate the potential of very small embryonic-like stem cells as a countermeasure to radiological and nuclear threat. The product candidate, which is an autologous stem cell therapy derived from the patient's own stem cells, will be developed to rescue patients who have been exposed to radiation due to nuclear accident or terrorist threat and to treat cancer patients who have undergone radiation therapy and who consequently have compromised immune systems. The award includes $295,252 for the first year and $300,000 for the second year of the project.

Dr. Denis O. Rodgerson, Director of Stem Cell Science for NeoStem, said, "We are very excited to add radiation treatment to the growing list of indications for which our VSELTM Technology is being evaluated. Those exposed to acute high-dose radiation have compromised immune systems such that the virulence and infectivity of biological agents is dramatically increased. Death can occur within 1-6 weeks following radiation exposure. Currently there is only one intervention that saves a fatally irradiated person -- a rescue through stem cell transplantation. VSELs might be an ideal cell therapy to regenerate the body's immune system and repair other tissues damaged by radiation exposure. Most importantly, early studies show VSELs are resistant to lethal radiation which destroys other immune system restoring stem cells in the body, making autologous treatment post-exposure possible."

Dr. Robin L. Smith, Chairman and CEO of NeoStem, added, "NeoStem is pleased that the NIAID is funding this cutting edge technology that we hope will reinvent the treatment landscape for acute radiation syndrome. We plan to continue to pursue NIH SBIR grants to fund our VSEL technology platform development with non-dilutive capital."

About VSELTM Technology

NeoStem has a worldwide exclusive license to VSELTM Technology. Research by Dr. Mariusz Ratajczak, M.D., Ph.D., and others at the University of Louisville provides compelling evidence that bone marrow contains a heterogeneous population of stem cells that have properties similar to those of an embryonic stem cell. These cells are referred to as very small embryonic-like stem cells. This finding opens the possibility of capturing some of the key advantages associated with embryonic stem cells without the ethical or moral dilemmas and without some of the potential negative biological effects associated with stem cells of embryonic derivation. The possibility of autologous VSEL treatments is yet another important potential benefit to this unique population of adult stem cells. VSELTM Technology offers the potential to go beyond the paracrine effect, yielding cells that actually differentiate into the target tissue creating true cellular regeneration.

About NeoStem, Inc.

NeoStem, Inc. ("we," "NeoStem" or the "Company") continues to develop and build on its core capabilities in cell therapy to capitalize on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a large role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. Our January 2011 acquisition of Progenitor Cell Therapy, LLC ("PCT") provides NeoStem with a foundation in both manufacturing and regulatory affairs expertise. We believe this expertise, coupled with our existing research capabilities and collaborations, will allow us to achieve our mission of becoming a premier cell therapy company. Our PCT subsidiary's manufacturing base is one of the few current Good Manufacturing Practices ("cGMP") facilities available for contracting in the burgeoning cell therapy industry. Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011, is developing a cell therapy for the treatment of cardiovascular disease. Amorcyte's lead compound, AMR-001, represents NeoStem's most clinically advanced therapeutic and Amorcyte is enrolling patients for a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. We also expect to begin a Phase 1 clinical trial by 2012/2013 to investigate AMR-001's utility in arresting the progression of congestive heart failure and the associated comorbidities of that disease. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is engaged in collaboration with Becton-Dickinson that is exploring the earlier stage clinical development of a T-cell therapy for autoimmune conditions. In addition, our pre-clinical assets include our VSELTM Technology platform as well as our MSC (mesenchymal stem cells) product candidate for regenerative medicine.

For more information on NeoStem, please visit http://www.neostem.com.

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NeoStem Awarded NIAID Research Grant for the Development of VSEL Technology for Radiation Exposure

Public release date: 25-Jun-2012 [ | E-mail | Share ]

Contact: Kim Menard kim.menard@uphs.upenn.edu 215-662-6183 University of Pennsylvania School of Medicine

PHILADELPHIA - A new test can be used to identify low-risk thyroid nodules, reducing unnecessary surgeries for people with thyroid nodules that have indeterminate results after biopsy. The results of the multi-center trial, which includes researchers from the Perelman School of Medicine at the University of Pennsylvania, appear online in the New England Journal of Medicine.

Ultrasound-guided fine-needle aspiration biopsies (FNA) accurately identify 62-85 percent of thyroid nodules as benign. For those deemed malignant or unclassifiable, surgery is currently required. However, about 20-35 percent of nodules have inconclusive results after FNA. This novel test classifies genes from the thyroid nodule tissue obtained through FNA.

"This test, currently available at Penn Medicine, can help us determine whether these nodules with indeterminate biopsy results are likely to be benign," said Susan Mandel, MD, MPH, professor of Medicine in Endocrinology, Diabetes and Metabolism in the Perelman School of Medicine at Penn."If so, patients may be able to avoid unnecessary surgeries and lifelong thyroid hormone replacement treatment."

In an accompanying NEJM editorial, J. Larry Jameson, MD, PhD, Dean of the Perelman School of Medicine and Executive Vice President for the Health System at the University of Pennsylvania, notes that the gene expression test is able to identify nodules at low risk of malignancy, making it possible to avoid approximately 25,000 thyroid surgeries per year. "In this era of focusing on high-quality outcomes at lower cost, this new gene expression classifier test is a welcome addition to the tools available for informed decision making about the management of thyroid nodules," writes Jameson.

The gene expression classifier was tested on 265 indeterminate thyroid nodules, and was able to correctly identify 92 percent of cases as suspicious. The test demonstrated a 85 - 95 percent negative predictive value, effectively ruling out a malignancy.

The Penn research team included Dr. Mandel, Zubair Baloch, MD, PhD, and Virginia A. LiVolsi, MD, both professors of Pathology and Laboratory Medicine. The investigation was funded by a research grant provided by Veracyte, Inc., the maker of the gene expression classifier.

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Penn Medicine is one of the world's leading academic medical centers, dedicated to the related missions of medical education, biomedical research, and excellence in patient care. Penn Medicine consists of the Raymond and Ruth Perelman School of Medicine at the University of Pennsylvania (founded in 1765 as the nation's first medical school) and the University of Pennsylvania Health System, which together form a $4.3 billion enterprise.

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Gene expression test identifies low-risk thyroid nodules

SAN DIEGO--(BUSINESS WIRE)--

Pathway Genomics Corporation, a San Diego-based genetic testing laboratory, has partnered with Diagnsticos da Amrica (DASA), the largest private medical diagnostics company in Latin America and the fourth largest provider of diagnostic services in the world. Based in Brazil, DASAs clinical analysis division collects samples from more than 500 patient service centers and has 11 central laboratories. DASAs brands include Alta Excelncia Diagnstica, Delboni Auriemo, Lavoisier, CDPI, Srgio Franco, Pasteur, Exame and others. Through this partnership, physicians have access to Pathways valuable genetic testing services, bringing additional personalized care to more than 180 million people in Brazil.

Pathways vision is to responsibly reveal personalized and actionable genetic information in order to globally educate, inform and improve health and well-being, said Dr. Michael Nova, Pathways chief medical officer. Our alignment with DASA is a major part of this vision, and we are excited to help bring this scientifically-advanced technology to the people of Brazil.

Specifically, through DASA, physicians in Brazil now have access to multiple genetic tests, including:

The partnership between DASA and Pathway represents a milestone in Brazilian medicine, ensuring access to predictive genetic tests through an advanced and innovative technology, said Dr. Octvio Fernandes, DASAs chief operating officer. DASA is a reference in Brazil due to our excellence, innovation and quality in medical diagnostic services. With 50 years of expertise, the company has one of the largest medical teams in Latin America, composed of nearly 2,000 world-renowned doctors, and offering more than 3,000 types of laboratory tests and imaging diagnostics provided by more than 18,000 professionals.

Pathways laboratory is accredited by the College of American Pathologists (CAP) and accredited in accordance with the U.S. Health and Human Services Clinical Laboratory Improvement Amendments (CLIA) of 1988. Pathway is also a member of the American Clinical Laboratory Association (ACLA). The company consists of more than 40 scientific and medical professionals, including medical doctors, molecular geneticists, and genetic counselors, as well as an expert scientific advisory board.

About Pathway Genomics Corporation

Pathway Genomics owns and operates an on-site genetic testing laboratory that is accredited by the College of American Pathologists (CAP), accredited in accordance with the U.S. Health and Human Services Clinical Laboratory Improvement Amendments (CLIA) of 1988, and licensed by the state of California. Using only a saliva sample, the company incorporates customized and scientifically validated technologies to generate personalized reports, which address a variety of medical issues, including an individuals carrier status for recessive genetic conditions, food metabolism and exercise response, prescription drug response, and propensity to develop certain diseases such as heart disease, type 2 diabetes and cancer. For more information about Pathway Genomics, visit http://www.pathway.com.

About DASA

DASA is the largest private medical diagnostics company in Latin America offering a portfolio of over 3,000 clinical analysis and imaging tests. In the clinical analysis segment, samples are collected in more than 500 patient service centers and analyzed in 11 central laboratories. In the diagnostic imaging segment, the images are submitted to physicians for analysis and reporting according to their medical specialty. For more information about DASA, visit http://www.dasa.com.br.

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Pathway Genomics Partners with DASA, the Largest Private Medical Diagnostics Company in Brazil

Brian Wellss job is to make big data and technology issues disappear for the researchers at the Perelman School of Medicine. He is building the technical infrastructure needed to achieve the goals of personalized medicine regarding biobanking and genetic sequencing. This associate chief information officer for Health Technology and Academic Computing at Penn Medicine recently spoke with MedCity News about some new developments at Penn including his thoughts on the challenge of sharing electronic medical records.

What have been some of the unforeseen consequences of the growth of information technology in healthcare?

There will be increasing desire to provide access to all that information the problem is we dont have unified standards for access. So the exchange of real data discretely is very difficult today.

What we call a white blood cell count at Penn is probably different than what Geisinger calls it and thats just one lab test. The exchange and utilization of data that can be acted on electronically is pretty constrained. We have many ways to record information, but not as many common ways to share information.

For example, there may be as many as 10 coding systems. LOINC is the industry standard for lab tests. In the world of drugs there are three to four different systems. For diagnoses, a 70-fold explosion in the world of codes is on the horizon. Were about to shift from ICD-09 to ICD-10 (the coding system tied to reimbursement).

What have been some of the biggest challenges faced in implementing EMR to meet Meaningful Use criteria?

We are in very good shape for stage 1. Stage 2 is a little more difficult. CMS will want us to be able to exchange data with other hospitals without the same software. And it must be a facility that has at least 10 percent of our patients. That may be daunting for a tertiary care facility like Penn.

What about personal health records?

The whole personal health record industry came and went and failed because patients are busy. Its a lot of work to constantly update a PHR. The concept of a tethered PHR in which records are linked and tethered to Penn (such as mypennmedicine.org) is having more success in the industry.

And the new standard the FCC has just announced, Medical Body Area Networks, or MBAN, will allow devices to transmit data without wires. Its a protected bandwidth the FCC will preserve and Im sure vendors are jumping on that technology and will make it easier and more reliable to transmit that data.

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Penn Medicine HIT expert: Patient expectations ahead of current EHR capabilities

WESTMINSTER, Colo., June 25, 2012 /PRNewswire/ --GeneThera Inc. (OTCQB: GTHR) is pleased to announce that Applied Genetics, GeneThera's majority owned subsidiary, has initiated commercial operation of its molecular diagnostic laboratory based in Monterrey, Mexico. Applied Genetics molecular diagnostic laboratory is the first molecular laboratory in Mexico, to date, which is capable to detect Johne's disease at the molecular level in milk, blood, and feces from dairy cows, goats and sheep infected with the disease using state-of-the-art molecular technology. Applied Genetics utilizes GeneThera proprietary Johne's disease HerdCheck Field Collection System (FCS) Molecular Assay. Dr. Tony Milici, interim president of Applied Genetics and CEO of GeneThera, stated; "The starting of Applied Genetics commercial operation is a great success for GeneThera. I think it is pretty remarkable that we were able to accomplish our goal in less than 18 months. This achievement was made possible thanks to the commitment and dedication of the Company's management and the outstanding support of our loyal investors and collaborators. I have to thank deeply all the people who believed in the Company and its ability to achieve its goals; I am grateful."

Nutrition Avanzada, GeneThera's exclusive buyer and distributor of the proprietary Johne's disease molecular system in Mexico, has entered into an agreement with a large veterinary laboratory in Northern Mexico. This agreement will provide access to about 20,000 animals initially. These animals will be tested for the presence of mycobacterium paratuberculosis in milk, blood and feces. Positive animals will be tested every 3 months to monitor progress of the disease. The cost of the test will range from US $30.00 $32.00. In addition, Nutrition Avanzada is in the final negotiation stages with two of the largest dairy companies in Mexico.

As previously announced Nutricion Avanzada will purchase the Johne's disease Field Collection System kit from Applied Genetics and resell it directly to third parties. Samples will be then shipped to Applied Genetics laboratory for processing. The commercial operation will be implemented in Three (3) Phases: during the current initial Phase (Phase I), Applied Genetics target is to process a maximum of 100 samples/daily. Phase II, to be initiated in late fall of 2012, will increase Applied Genetics sample process throughput to 1500 samples/daily. Phase II will be implemented in the early part of 2013, which will further increase sample throughput to over 2000 samples daily.

Johne's disease is a global devastating and incurable disease of dairy cows, sheep and goats caused by a bacterium called Mycobacterium Paratuberculosis sub. Avium, (MAP). Dairy products, contaminated with MAP, are the vehicles by which the infection spreads in the human intestine triggering the onset of Crohn's disease. Applied Genetics employs the use of GeneThera HerdCheck to test and control the spread of Johne's disease in Mexico. HerdCheck is a proprietary molecular diagnostic system based on the use of high throughput robotics and Real time PCR.

About GeneThera, Inc.

GeneThera, Inc. is a molecular biotechnology company located in Westminster, Colorado. The Company's proprietary diagnostic solution is based on a genetic expression system, GES and Johne's disease management system, HERDCHECK designed to function on a highly automated Fluorogenic PCR platform. This platform enables GeneThera to offer tests that are presently not available from other technologies. The GES and HERDCHECK systems are designed for a host of individual diseases, the current priority being Johne's disease. For more information, contact Dr. Tony Milici at 720-439-3011. http://www.genethera.net

This press release contains forward-looking statements, which are made pursuant to the Safe-Harbor provisions of the Private Securities Litigation Reform Act of 1995. Words such as "intends," "believes," and similar expressions reflecting something other than historical fact are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. These forward-looking statements involve a number of risks and uncertainties, including the timely development and market acceptance of products and technologies, the ability to secure additional sources of finance, the ability to reduce operating expenses, and other factors described in the Company's filings with the Securities and Exchange Commission. The actual results that the Company achieves may differ materially from any forward-looking statement due to such risks and uncertainties. The Company undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release.

GeneThera, Inc

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Applied Genetics Initiates Commercial Operation

Public release date: 25-Jun-2012 [ | E-mail | Share ]

Contact: Vicki Cohn vcohn@liebertpub.com 914-740-2100 x2156 Mary Ann Liebert, Inc./Genetic Engineering News

New Rochelle, NY, June 25, 2012Gene therapy to replace the protein missing in Pompe disease can be effective if the patient's immune system does not react against the therapy. Targeted delivery of the gene to the liver, instead of throughout the body,suppresses the immune response, improving the therapeutic effect, according to an article published in Human Gene Therapy, a peer-reviewed journal from Mary Ann Liebert, Inc. The article is available free online at the Human Gene Therapy website.

"The current unmet medical need in Pompe disease is for prevention of immune responses against standard-of-care enzyme replacement therapy," says coauthor Dwight Koeberl, MD, PhD. "However, we foresee a future application of the dual vector strategy described in this paper, including a liver-expressing vector along with a ubiquitously expressing vector, which might achieve much higher efficacy than either vector alone."

In the article "Immunodominant Liver-Specific Expression Suppresses Transgene-Directed Immune Responses in Murine Pompe Disease," Ping Zhang and coauthors from Duke University Medical Center (Durham, NC), targeted a gene delivery vector carrying the therapeutic gene to the livers of mice with Pompe disease. Not only did the liver-specific expression of the protein induce immune tolerance, but when combined with non-targeted delivery of the therapeutic gene it also boosted the overall effectiveness of the treatment.

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About the Journal

Human Gene Therapy, the Official Journal of the European Society of Gene and Cell Therapy, British Society for Gene Therapy, French Society of Cell and Gene Therapy, German Society of Gene Therapy, and five other gene therapy societies is an authoritative peer-reviewed journal published monthly in print and online that presents reports on the transfer and expression of genes in mammals, including humans. Related topics include improvements in vector development, delivery systems, and animal models, particularly in the areas of cancer, heart disease, viral disease, genetic disease, and neurological disease, as well as ethical, legal, and regulatory issues related to the gene transfer in humans. Tables of content and a free sample issue may be viewed online at the Human Gene Therapy website.

About the Publisher

Mary Ann Liebert, Inc. is a privately held, fully integrated media company known for establishing authoritative peer-reviewed journals in many promising areas of science and biomedical research, including Tissue Engineering, Stem Cells and Development, and Cellular Reprogramming. Its biotechnology trade magazine, Genetic Engineering & Biotechnology News (GEN), was the first in its field and is today the industry's most widely read publication worldwide. A complete list of the firm's 70 journals, books, and newsmagazines is available at the Mary Ann Liebert, Inc. website.

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Targeted gene therapy enhances treatment for Pompe disease