Archive for the ‘Gene Therapy Research’ Category
DNA research: Contribution to gene therapy – Important BYU research debunks the idea of "junk DNA"
Important BYU research debunks the idea of "junk DNA"
The human body contains approximately 50 trillion cells whose length of DNA content compares to 528 million donuts wrapped around the earth 2,500 times.
Until recently, scientists thought 95 percent of that DNA was junk and had no function. BYU microbiology professor Steven Johnson and one of his undergraduate assistants, Elliot Winters, participated in a worldwide collaborative research project, the ENCODE Projectconcluded 80 percent of a persons DNA does perform an important function.
Its the culmination of this international consortium saying all this DNA that we thought didnt have a function actually has a function or has something going on, Johnson said. We dont know exactly what is going on, but its not just junk that is sitting there with no purpose.
The collaborative research project, the ENCODE Project, provides a database of information to those performing genetic research. The research was published in Genome Research, and Johnson and Winters are listed as co-authors.
[/media-credit] Mentored research provides exceptional opportunities for BYU students
We told them exactly how we wanted the cells prepared, and they sent them to us frozen, Johnson said. I taught my undergraduate student, Elliot Winters, this technique that Id developed. Over a course of about four months, we were able to get it to work just right and isolate just the DNA that we wanted to with the nucleosomes.
Winters is not alone in doing mentored undergraduate research atBYU. According to the BYU website,the university gave $1.4 million to 71 faculty members specifically for projects involving undergraduates. Winters identifies his research experience as one of the most important parts of his BYU education.
The reason I started doing it is because I wanted to strengthen my application for medical school, Winters said. Looking back on it, it was one of the most valuable parts of my education.
Winters is only one of many students Johnson employs in his labs. Colton Kempton, a third-year masters student from Safford, Ariz., is currently working with Johnson on more DNA research related to gene therapy.
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DNA research: Contribution to gene therapy - Important BYU research debunks the idea of "junk DNA"
Immunovative, Inc. Announces Issuance of U.S. Patent on Key Scientific Breakthrough
NEW YORK, NY--(Marketwire - Oct 11, 2012) - Immunovative, Inc. ("IMUN" or the "Company") ( OTCBB : IMUN ) has today announced that Immunovative Therapies, Ltd. ("ITL") has been granted a U.S. Patent entitled "METHOD FOR ALLOGENEIC CELL THERAPY," which was issued September 25, 2012, under Patent No. 8,273,377. Foreign versions of this patent are pending around the world. This patent covers the proprietary method that utilizes immune cells from a normal donor to elicit an anti-tumor mechanism that mimics the Graft vs. Tumor (GVT) effect of non-myeloablative allogeneic stem cell transplants ("Mini-Transplant") without the toxicity of Graft vs. Host Disease (GVHD). Harnessing the power of the immune system to treat cancer and infectious disease has long been the goal of physicians and scientists. Unfortunately, cancer vaccines and cell immunotherapy methods have had difficulties in translating the promise of immune control into effect treatments. The most effective anti-cancer mechanism ever discovered is the GVT immune response that occurs after Mini-Transplant procedures. This mechanism can completely destroy chemotherapy-resistant metastatic cancers. Unfortunately, the clinical use of the GVT effect is severely limited due to extreme toxicity of an intimately related GVHD effect. Mini-Transplants are thus only widely used in advanced cases of leukemia, even though the GVT effect has been shown capable of killing many types of solid tumors. The separation of the beneficial GVT effect from the devastating GVHD toxicity has long been the goal of stem cell transplant scientists and is the subject of extensive research around the world.
ITL is believed to be the first to develop an immunotherapy drug product (AlloStim) which enables the harnessing of the power of the GVT mechanism without GVHD side effects. ITL calls the mechanism which enables immune-mediated tumor destruction without GVHD toxicity the "Mirror Effect." The "Mirror Effect" mechanism represents a major breakthrough for treatment of cancer and infectious disease. Early human clinical trials have produced evidence of this technology's capability to stimulate the immune systems of heavily pre-treated metastatic cancer patients to kill widely disseminated metastatic cancers. A potentially pivotal, double-blind, placebo-controlled Phase II/III clinical trial in metastatic breast cancer is being prepared to document these effects in a controlled setting and determine if the immune-mediated tumor debulking provides patients with a survival advantage. This issued US Patent covers the use of intentionally mismatched, activated immune cells for treatment of cancer and infectious diseases. The patent discloses the concepts and methods related to ITL's proprietary "Mirror Effect" technology and describes its lead immunotherapy drug candidate "AlloStim." This patent also describes how AlloStim eliminates the need for a matched tissue donor and chemotherapy pre-conditioning for patients that require a bone marrow or stem cell transplant.
The newly issued patent is part of an intellectual property portfolio from ITL that includes 11 issued patents and numerous patent applications, to which IMUN has exclusive rights in the US and the rest of the world. The licensed patents cover compositions, methods of production, formulation, distribution and uses for treatment of all types of cancer and infectious diseases.
Seth M. Shaw, CEO of IMUN, stated: "The separation of the beneficial GVT effect from the devastating GVHD toxicity has been called the 'Holy Grail' of transplant research. ITL is the first to accomplish this significant scientific milestone. We are confident that ITL's extensive Intellectual Property ("IP") portfolio will provide our products with long-term market exclusivity. This patent is an important component of our growing IP estate, as the allowed claim language is very broad. We are now the exclusive allogeneic cell therapy company in the world. Our strong patent portfolio will now allow us to pursue opportunities for partnering and sub-licensing by indication and territory around the world."
Dr. Michael Har-Noy, CEO, founder of ITL and inventor of the "Mirror Effect" technology stated: "Our patent portfolio is a valuable asset as it not only protects our AlloStim and AlloVax product candidates, but also provides protection of the unique mechanism of action that enables these products to have such powerful potential to debulk treatment-resistant metastatic disease. We are continuing to invest in research activities to improve our current product candidates and develop new products and further expand our patent portfolio. With protection of the novel mechanism of action, ITL and IMUN have the basis for development of a new industry based on powerful, non-toxic immunotherapy products that can work where all current treatment options have failed."
About Immunovative, Inc.: On December 12th, 2011, Immunovative, Inc. ("IMUN") signed an exclusive License Agreement (the "License Agreement") with Immunovative Therapies, Ltd. ("ITL"). Under the terms of the License Agreement, IMUN has been granted an exclusive, worldwide license to commercialize any products covered under ITL's current issued and pending patent application portfolio, as well as the rights to any future patent applications, including improvements or modifications to the existing applications and any corresponding improvements or new versions of the existing products. Please visit IMUN's website at http://www.imun.com.
About Immunovative Therapies, Ltd.:
Immunovative Therapies, Ltd. is an Israeli biopharmaceutical company that was founded in May 2004 with financial support from the Israeli Office of the Chief Scientist. ITL is a graduate of the Misgav Venture Accelerator, a member of the world-renowned Israeli technological incubator program. The company was the Misgav Venture Accelerator's candidate for the prize for the outstanding incubator project of 2006, awarded by the Office of the Chief Scientist. ITL specializes in the development of novel immunotherapy drug products that incorporate living immune cells as the active ingredients for treatment of cancer and infectious disease. Please visit ITL's website at: http://www.immunovative.co.il
DISCLAIMER: Forward-Looking Statements: Except for statements of historical fact, this news release contains certain "forward-looking statements" as defined by the Private Securities Litigation Reform Act of 1995, including, without limitation, expectations, beliefs, plans and objectives regarding the development, use and marketability of products. Such forward-looking statements are based on present circumstances and on IMUN's predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements involve known and unknown risks, uncertainties and other factors, and are not guarantees of future performance or results and involve risks and uncertainties that could cause actual events or results to differ materially from the events or results expressed or implied by such forward-looking statements. Such factors include general economic and business conditions, the ability to successfully develop and market products, consumer and business consumption habits, the ability to fund operations and other factors over which IMUN has little or no control. Such forward-looking statements are made only as of the date of this release, and IMUN assumes no obligation to update forward-looking statements to reflect subsequent events or circumstances. Readers should not place undue reliance on these forward-looking statements. Risks, uncertainties and other factors are discussed in documents filed from time to time by IMUN with the Securities and Exchange Commission.
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Immunovative, Inc. Announces Issuance of U.S. Patent on Key Scientific Breakthrough
First Patient Treated in Cytori’s U.S. Cell Therapy Heart Failure Trial
SAN DIEGO & MINNEAPOLIS--(BUSINESS WIRE)--Cytori Therapeutics (NASDAQ: CYTX) announced the initiation of the FDA approved ATHENA clinical trial to investigate Cytoris cell therapy in patients who suffer from a severe form of refractory (untreatable) heart failure due to chronic myocardial ischemia. Cytoris cell therapy is based on a patients own adipose-derived stem and regenerative cells (ADRCs) processed by the Companys proprietary Celution System technology, making this the first FDA approved trial in the U.S. to evaluate ADRCs for cardiovascular disease. This first patient was treated by co-principal investigator Timothy Henry, M.D., Director of Research, at the Minneapolis Heart Institute Foundation in September and has undergone a seven day follow-up assessment. More details on the ATHENA trial may be found at http://www.theathenatrial.com.
Patients with refractory heart failure have no options except for heart transplant, for which there are few hearts available
Patients with refractory heart failure have no options except for heart transplant, for which there are few hearts available, said Dr. Henry. Cell therapy such as Cytoris has the potential to delay, halt, or even reverse this progression. We believe this is accomplished by the cells ability to promote angiogenesis and regulate the immune response to help revive damaged tissue that is alive yet not necessarily contributing to its fullest capacity toward the pumping ability of the heart.
ATHENA is a device-based, multi-center, prospective, randomized, double-blind PMA/IDE safety and feasibility (Phase I/II) trial that will enroll 45 patients in six centers in the U.S. Patients will be randomized to receive either Cytoris cell therapy (n=30) or an inactive placebo injection (n=15). All trial participants will undergo a minor liposuction procedure to remove adipose tissue. The adipose tissue will then be processed at the point-of-care with Cytoris proprietary system to separate and concentrate clinical-grade ADRCs. The treatment group will have a prescribed dose of the patients own ADRCs (0.4 million cells/kg body weight), which will then be injected into their damaged heart tissue using a minimally invasive catheter system.
Cytoris cell therapy has unique advantages compared to alternate cell sources such as bone marrow and peripheral blood, said Emerson Perin, M.D., Ph.D. of The Texas Heart Institute and co-principal investigator for ATHENA. Specifically, its a proprietary formulation that Cytori has optimized for vascular delivery and which contains an uncultured and mixed population of cells. As a result, this increases the number of cell types that potentially contribute to repair relative to a more homogenous population of cultured cells.
The trial will measure several endpoints, including peak oxygen consumption (VO2 Max). VO2 Max is an objective functional measurement that can be predictive of outcomes in heart disease, including mortality, and is commonly used as a primary determinant for qualifying patients for heart transplantation. Additional endpoints include perfusion defect, left ventricle end-systolic and diastolic volume and ejection fraction at six and 12 months. ATHENA will also evaluate medical economic factors such as rate of re-hospitalization and heart failure symptoms such as angina and quality of life at 12 months.
We believe Cytoris cell therapy will improve patient outcomes, said Marc H. Hedrick, M.D., president, Cytori Therapeutics. In ATHENA, investigators will be delivering a virtually off-the-shelf cell therapy comprised of a patients own cells, which is made possible by our technology. Using a patients own cells minimizes the risk of rejection or disease transmission compared to alternative therapies derived from donor cells and the virtually off-the-shelf nature allows the treatment to be accomplished in a single surgical procedure.
Cytori received approval from the FDA for its Investigational Device Exemption (IDE) application to begin ATHENA in January 2012 and the trial is currently expected to complete enrollment in mid-2013. In addition to Minneapolis Heart Institute Foundation, the Texas Heart Institute (Houston, TX) is actively screening patients under the direction of Emerson Perin, M.D., Ph.D., co-principal investigator for ATHENA, and James T. Willerson, M.D. Four additional centers are also expected to participate in the trial including:
Previously, Cytori reported six and 18-month safety and feasibility data from the PRECISE trial, a European clinical trial for this same indication. The PRECISE trial demonstrated a statistically significant improvement in VO2 Max in patients treated with Cytoris cell therapy compared to those treated with placebo. The Company is also conducting the ADVANCE trial, a European pivotal trial investigating the effect of Cytoris cell therapy in heart attack patients.
Refractory Heart Failure
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First Patient Treated in Cytori’s U.S. Cell Therapy Heart Failure Trial
StemGenex™ on Adult Stem Cell-Based Therapy for Multiple Sclerosis
LA JOLLA, Calif., Oct. 10, 2012 /PRNewswire/ --New research directions are being explored to find therapies for hard to treat diseases. One exciting new approach is the use of autologous Adult Stem Cells. Multiple Sclerosis (MS) is one of the many notable diseasesadult stem cell therapycould potentially impact. Multiple Sclerosis (MS) is a disorder in which an individual's own immune system attacks the 'myelin sheath'. The myelin sheath serves to protect the nerve cells within the body's central nervous system (CNS). The damage caused by MS may result in many types of symptoms including:
(Photo: http://photos.prnewswire.com/prnh/20121010/LA89802-INFO)
Currently there is no cure for MS, but MS stem cell therapiesattempt to slow the disease's progression and limit symptoms. Since adult stem cells have the ability to differentiate into many different types of cells, such as those required for proper functioning and protection of nerve cells, the use of adult stem cells for MS therapy could be of substantial value. Adult stem cells can be isolated with relative ease from an individual's own 'adipose' (fat) tissue. As a result, adult stem cell therapy is not subject to the ethical or religious issues troubling embryonic methods.
Encouragingly for MS treatment potential, scientific researchers have been studying the properties of adipose-derived stem cells. Their results from canine and equine studies suggest anti-inflammatory and regenerative roles for these stem cells. Also, further research findings suggest these adipose-derived stem cells can have specific immune-regulating properties. Markedly, clinical-based work conducted overseas has indicated that individuals suffering from MS could respond well to adipose-derived stem cell treatment, with a substantially improved quality of life.
The US based company, StemGenex, is pioneering new methods for using adipose derived adult stem cells to help in diseases with limited treatment options like MS. StemGenex has been conducting research with physicians over the last 5 years to advance adult stem cell treatment protocols for alleviating MS symptoms. StemGenex's proprietary protocol includes the use of a double activation process, which increases both the viability and the quantity of stem cells that are received in a single application.
To find out more about stem cell treatments contact StemGenex either by phone at 800.609.7795 or email at Contact@StemGenex.com.
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StemGenex™ on Adult Stem Cell-Based Therapy for Multiple Sclerosis
Test Spots Newborn Gene Disease
WASHINGTON (AP) - Too often, newborns die of genetic diseases before doctors even know what is to blame. Now scientists have found a way to decode those babies' DNA in just days instead of weeks, moving gene-mapping closer to routine medical care.
The idea: Combine faster gene-analyzing machinery with new computer software that, at the push of a few buttons, uses a baby's symptoms to zero in on the most suspicious mutations. The hope would be to start treatment earlier, or avoid futile care for lethal illnesses.
Wednesday's study is a tentative first step: Researchers at Children's Mercy Hospital in Kansas City, Missouri, mapped the DNA of just five children, and the study wasn't done in time to help most of them.
But the hospital finds the results promising enough that by year's end, it plans to begin routine gene-mapping in its neonatal intensive care unit - and may offer testing for babies elsewhere, too - while further studies continue, said Dr. Stephen Kingsmore, director of the pediatric genome center at Children's Mercy.
``For the first time, we can actually deliver genome information in time to make a difference," predicted Kingsmore, whose team reported the method in the journal Science Translational Medicine. Even if the diagnosis is a lethal disease, ``the family will at least have an answer. They won't have false hope," he added.
More than 20 percent of infant deaths are due to a birth defect or genetic diseases, the kind caused by a problem with a single gene. While there are thousands of such diseases - from Tay-Sachs to the lesser known Pompe disease, standard newborn screening tests detect only a few of them. And once a baby shows symptoms, fast diagnosis becomes crucial.
Sequencing whole genomes - all of a person's DNA - can help when it is not clear what gene to suspect. But so far it has been used mainly for research, in part because it takes four to six weeks to complete and is very expensive.
Wednesday, researchers reported that the new process for whole-genome sequencing can take just 50 hours, half that time to perform the decoding from a drop of the baby's blood, and the rest to analyze which of the DNA variations uncovered can explain the child's condition.
That's an estimate: The study counted only the time the blood was being decoded or analyzed, not the days needed to ship the blood to Essex, England, home of a speedy new DNA decoding machine made by Illumina, Inc., or to ship back the results for Children's Mercy's computer program to analyze. Kingsmore said the hospital is awaiting arrival of its own decoder, when 50 hours should become the true start-to-finish time.
Specialists not involved with the study said it signals the long-promised usefulness of gene-mapping to real-world medicine finally is close. ``Genomic sequencing like this is very practical and very real now," said Dr. Arthur Beaudet of the Baylor College of Medicine, which also is working to expand genomic testing in children. ``Fast forward a year, and I think this kind of thing will probably be pretty routine."
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Test Spots Newborn Gene Disease
Mount Sinai researchers discover gene signature that predicts prostate cancer survival
Public release date: 10-Oct-2012 [ | E-mail | Share ]
Contact: Mount Sinai Press Office newsmedia@mssm.edu 212-241-9200 The Mount Sinai Hospital / Mount Sinai School of Medicine
Researchers from Mount Sinai School of Medicine have identified a six-gene signature that can be used in a test to predict survival in men with aggressive prostate cancer, according to new research published in the October issue of The Lancet Oncology. This is the first study to demonstrate how prognostic markers may be useful in a clinical setting.
Using blood from 202 men with treatment-resistant prostate cancer, researchers found six genes characteristic of treatment-resistant prostate cancer. Men with the six-gene signature were high-risk, with a survival time of 7.8 months, and men without it were low-risk, with a survival time of approximately 34.9 months. A replication study of 140 additional patients validated these findings. William K. Oh, MD, Chief of the Division of Hematology and Medical Oncology of The Tisch Cancer Institute at The Mount Sinai Medical Center, led the research team.
"There is an urgent need for predictive models that help assess how aggressive the disease is in prostate cancer patients, as survival can vary greatly," said Dr. Oh. "Our six-gene model, delivered in a simple blood test, will allow clinicians to better determine the course of action for their patients, determine clinical trial eligibility, and lead to more targeted studies in late-stage disease."
Until now, disease prognosis in advanced prostate cancer could only be determined through clinical predictors or, occasionally, tumor biopsies with only moderately predictive results. This study shows the efficacy of the six-gene model blood test in determining length of survival.
"The genes noted in the model suggest possible changes in the immune system related to late-stage disease that warrant further study as a target for immune-based therapies," said Dr. Oh.
Dr. Oh's team is conducting additional studies exploring the feasibility of the six-gene signature in other types of prostate cancer, the stability of the signature during the course of a patient's illness, and the predictive ability of this signature in patients with prostate cancer treated with immune-based therapies.
###
This work was done in collaboration with colleagues at Dana-Farber Cancer Institute in Boston and Memorial Sloan-Kettering Cancer Center in New York City.
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Mount Sinai researchers discover gene signature that predicts prostate cancer survival
Researchers Discover Gene Signature that Predicts Prostate Cancer Survival
Newswise Researchers from Mount Sinai School of Medicine have identified a six-gene signature that can be used in a test to predict survival in men with aggressive prostate cancer, according to new research published in the October issue of The Lancet Oncology. This is the first study to demonstrate how prognostic markers may be useful in a clinical setting.
Using blood from 202 men with treatment-resistant prostate cancer, researchers found six genes characteristic of treatment-resistant prostate cancer. Men with the six-gene signature were high-risk, with a survival time of 7.8 months, and men without it were low-risk, with a survival time of approximately 34.9 months. A replication study of 140 additional patients validated these findings. William K. Oh, MD, Chief of the Division of Hematology and Medical Oncology of The Tisch Cancer Institute at The Mount Sinai Medical Center, led the research team.
"There is an urgent need for predictive models that help assess how aggressive the disease is in prostate cancer patients, as survival can vary greatly," said Dr. Oh. "Our six-gene model, delivered in a simple blood test, will allow clinicians to better determine the course of action for their patients, determine clinical trial eligibility, and lead to more targeted studies in late-stage disease."
Until now, disease prognosis in advanced prostate cancer could only be determined through clinical predictors or, occasionally, tumor biopsies with only moderately predictive results. This study shows the efficacy of the six-gene model blood test in determining length of survival.
The genes noted in the model suggest possible changes in the immune system related to late-stage disease that warrant further study as a target for immune-based therapies, said Dr. Oh.
Dr. Ohs team is conducting additional studies exploring the feasibility of the six-gene signature in other types of prostate cancer, the stability of the signature during the course of a patients illness, and the predictive ability of this signature in patients with prostate cancer treated with immune-based therapies.
This work was done in collaboration with colleagues at Dana-Farber Cancer Institute in Boston and Memorial Sloan-Kettering Cancer Center in New York City.
About The Mount Sinai Medical Center The Mount Sinai Medical Center encompasses both The Mount Sinai Hospital and Mount Sinai School of Medicine. Established in 1968, Mount Sinai School of Medicine is one of the leading medical schools in the United States. The Medical School is noted for innovation in education, biomedical research, clinical care delivery, and local and global community service. It has more than 3,400 faculty in 32 departments and 14 research institutes, and ranks among the top 20 medical schools both in National Institutes of Health (NIH) funding and by US News and World Report.
The Mount Sinai Hospital, founded in 1852, is a 1,171-bed tertiary- and quaternary-care teaching facility and one of the nations oldest, largest and most-respected voluntary hospitals. In 2011, US News and World Report ranked The Mount Sinai Hospital 14th on its elite Honor Roll of the nations top hospitals based on reputation, safety, and other patient-care factors. Mount Sinai is one of 12 integrated academic medical centers whose medical school ranks among the top 20 in NIH funding and US News and World Report and whose hospital is on the US News and World Report Honor Roll. Nearly 60,000 people were treated at Mount Sinai as inpatients last year, and approximately 560,000 outpatient visits took place. For more information, visit http://www.mountsinai.org/.
Find Mount Sinai on: Facebook: http://www.facebook.com/mountsinainyc Twitter: @mountsinainyc YouTube: http://www.youtube.com/mountsinainy
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Researchers Discover Gene Signature that Predicts Prostate Cancer Survival
Bioethics panel urges more gene privacy protection
WASHINGTON (AP) It sounds like a scene from a TV show: Someone sends a discarded coffee cup to a laboratory where the unwitting drinker's DNA is decoded, predicting what diseases lurk in his or her future.
A presidential commission found that's legally possible in about half the states and says new protections to ensure the privacy of people's genetic information are critical if the nation is to realize the enormous medical potential of gene-mapping.
Such whole genome sequencing costs too much now for that extreme coffee-cup scenario to be likely. But the report being released Thursday says the price is dropping so rapidly that the technology could become common in doctors' offices very soon and there are lots of ethical issues surrounding how, when and with whom the results may be shared.
Without public trust, people may not be as willing to allow scientists to study their genetic information, key to learning to better fight disease, the report warns.
"If this issue is left unaddressed, we could all feel the effects," said Dr. Amy Gutmann, who chairs the Presidential Commission for the Study of Bioethical Issues.
Mapping entire genomes now is done primarily for research, as scientists piece together which genetic mutations play a role in various diseases. It's different than getting a lab test to see if you carry, say, a single gene known to cause breast cancer.
Gutmann said her commission investigated ahead of an anticipated boom in genome sequencing as the price drops from thousands today to about $1,000, cheaper than running a few individual gene tests.
The sheer amount of information in a whole genome increases the privacy concerns. For example, people may have their genomes sequenced to study one disease that runs in the family, only to learn they're also at risk for something else with implications for relatives who may not have wanted to know.
Thursday's report shows a patchwork of protection. A 2008 federal law prohibits employers or health insurers from discriminating on the basis of genetic information, so that people don't put off a potentially important gene test for fear of losing their job or health coverage. But that law doesn't prevent denial of life insurance or long-term care insurance. Plus, there's little oversight of how securely genetic information is stored electronically, the report found.
Then there's the question of surreptitiously ordering genome screening from a private lab, such as during a nasty custody battle. The report didn't say that's ever happened, just that it could, and found no overarching federal or industry guidelines on how commercial testing companies should operate.
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Bioethics panel urges more gene privacy protection
Bioethics panel urges better protection of gene testing results privacy
WASHINGTON It sounds like a scene from a TV show: Someone sends a discarded coffee cup to a laboratory, where the unwitting drinker's DNA is decoded, predicting what diseases lurk in his or her future.
A presidential commission found that's legally possible in about half the states and says new protections to ensure the privacy of people's genetic information are critical if the nation is to realize the enormous medical potential of gene-mapping.
Such whole genome sequencing costs too much now for that extreme coffee-cup scenario to be likely. But the report being released Thursday says the price is dropping so rapidly that the technology could become common in doctors' offices very soon and there are lots of ethical issues surrounding how, when and with whom the results may be shared.
Without public trust, people may not be as willing to allow scientists to study their genetic information, key to learning to better fight disease, the report warns.
"If this issue is left unaddressed, we could all feel the effects," said Dr. Amy Gutmann, who chairs the Presidential Commission for the Study of Bioethical Issues.
Mapping entire genomes now is done primarily for research, as scientists piece together which genetic mutations play a role in various diseases. It's different than getting a lab test to see if you carry, say, a single gene known to cause breast cancer.
Gutmann said her commission investigated ahead of an anticipated boom in genome sequencing as the price drops from thousands today to about $1,000, cheaper than running a few individual gene tests.
The sheer amount of information in a whole genome increases the privacy concerns. For example, people may have their genomes sequenced to study one disease that runs in the family, only to learn they're also at risk for something else with implications for relatives who may not have wanted to know.
Thursday's report shows a patchwork of protection. A 2008 federal law prohibits employers or health insurers from discriminating on the basis of genetic information, so people don't put off a potentially important gene test for fear of losing their job or health coverage.
But that law doesn't prevent denial of life insurance or long-term care insurance. Plus, there's little oversight of how securely genetic information is stored electronically, the report found.
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Bioethics panel urges better protection of gene testing results privacy
Gene signature predicts prostate cancer survival
ScienceDaily (Oct. 10, 2012) Researchers from Mount Sinai School of Medicine have identified a six-gene signature that can be used in a test to predict survival in men with aggressive prostate cancer, according to new research published in the October issue of The Lancet Oncology. This is the first study to demonstrate how prognostic markers may be useful in a clinical setting.
Using blood from 202 men with treatment-resistant prostate cancer, researchers found six genes characteristic of treatment-resistant prostate cancer. Men with the six-gene signature were high-risk, with a survival time of 7.8 months, and men without it were low-risk, with a survival time of approximately 34.9 months. A replication study of 140 additional patients validated these findings. William K. Oh, MD, Chief of the Division of Hematology and Medical Oncology of The Tisch Cancer Institute at The Mount Sinai Medical Center, led the research team.
"There is an urgent need for predictive models that help assess how aggressive the disease is in prostate cancer patients, as survival can vary greatly," said Dr. Oh. "Our six-gene model, delivered in a simple blood test, will allow clinicians to better determine the course of action for their patients, determine clinical trial eligibility, and lead to more targeted studies in late-stage disease."
Until now, disease prognosis in advanced prostate cancer could only be determined through clinical predictors or, occasionally, tumor biopsies with only moderately predictive results. This study shows the efficacy of the six-gene model blood test in determining length of survival.
"The genes noted in the model suggest possible changes in the immune system related to late-stage disease that warrant further study as a target for immune-based therapies," said Dr. Oh.
Dr. Oh's team is conducting additional studies exploring the feasibility of the six-gene signature in other types of prostate cancer, the stability of the signature during the course of a patient's illness, and the predictive ability of this signature in patients with prostate cancer treated with immune-based therapies.
This work was done in collaboration with colleagues at Dana-Farber Cancer Institute in Boston and Memorial Sloan-Kettering Cancer Center in New York City.
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Gene signature predicts prostate cancer survival
Cheap genome sequences demand new rules on privacy
Peter Aldhous, San Francisco bureau chief In the era of the $1000 human genome, new rules will be needed to protect people's genetic privacy.
The US government and individual states should harmonize a mish-mash of laws to ensure a basic "floor" of genetic privacy protection across the nation, however the data information was obtained, the commission adds. For instance, if a volunteer has their genome sequenced for research, the information should have similar protection from prying eyes as if the analysis had been ordered by a doctor for diagnostic purposes.
Breaches in security of DNA sequence data held on computer systems are the most obvious threat. But in 2009, New Scientist pointed to another danger by simulating the surreptitious analysis of my genome: a colleague used commercially available services to extract DNA from a glass from which I had drunk, and analyse it for my genetic predispositions to disease.
We ordered a scan of about 1 million letters of my genetic code, but plummeting prices and advancing technology will soon make it feasible to obtain a full genome sequence in a similar way, at modest cost.
The new report comes down firmly against surreptitious genome sequencing:"[P]olicies should protect individual privacy by prohibiting unauthorized whole genome sequencing without the consent of the individual from whom the sample came."
This is part of a larger patchwork of regulation on genetic privacy that the bioethics commission wants to see overhauled.
Geneticists taking samples for research are not covered by HIPAA, but separate rules covering informed consent and the protection of research subjects. Researchers are usually careful to protect volunteers' privacy, but if breaches were to occur, those responsible would not be subject to the same criminal prosecution.
Without clear and consistent guidelines to protect personal genetic information, the bioethics commission fears that people could suffer harm - in part by keeping secret information that could help their doctors provide better treatment.
It was only when Grove developed a bout of pneumonia that she knew could lead to permanent lung damage for people with the condition that she broke down, explaining in a tearful phone call to a clinic why she needed an urgent prescription for antibiotics.
"If it's too difficult for those companies to operate, we may have a bottleneck in providing access to the patient who needs that information," she says.
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Cheap genome sequences demand new rules on privacy
Citing privacy concerns, U.S. panel urges end to secret DNA testing
NEW YORK (Reuters) - They're called discreet DNA samples, and the Elk Grove, California, genetic-testing company easyDNA says it can handle many kinds, from toothpicks to tampons.
Blood stains from bandages and tampons? Ship them in a paper envelope for paternity, ancestry or health testing. EasyDNA also welcomes cigarette butts (two to four), dental floss ("do not touch the floss with your fingers"), razor clippings, gum, toothpicks, licked stamps and used tissues if the more standard cheek swab or tube of saliva isn't obtainable.
On Thursday it released a report on privacy concerns triggered by the advent of whole genome sequencing, determining someone's complete DNA make-up. Although sequencing "holds enormous promise for human health and medicine," commission chairwoman Amy Gutmann told reporters on Wednesday, there is a "potential for misuse of this very personal data."
"In many states someone can pick up your discarded coffee cup and send it for (DNA) testing," said Gutmann, who is the president of the University of Pennsylvania.
"It's not a fantasy to think about how, without baseline privacy protection, people could use this in a way that would be really detrimental," such as by denying someone with a gene that raises their risk of Alzheimer's disease long-term care insurance, or to jack up life insurance premiums for someone with an elevated genetic risk of a deadly cancer that strikes people in middle age.
"Those who are willing to share some of the most intimate information about themselves for the sake of medical progress should be assured appropriate confidentiality, for example, about any discovered genetic variations that link to increased likelihood of certain diseases, such as Alzheimer's, diabetes, heart disease and schizophrenia," Gutmann said.
The commission took on the issue because whole genome sequencing is poised to become part of mainstream medical care, especially by personalizing medical treatments based on a patient's DNA.
$1,000 GENOME
That has been driven in large part by dramatic cost reductions, from $2.5 billion per genome in the Human Genome Project of the 1990s and early 2000s to $1,000 soon. Several companies, including Illumina Inc. and Life Technology's Ion Torrent division, sell machines that can sequence a genome for a few hundred dollars, but that does not include the analysis to figure out what the string of 3 billion DNA "letters" means.
A three-year-old federal law prohibits discrimination in employment or health insurance based on someone's genetic information but does not address other potential misuses of the data. Without such privacy protection, said Gutmann, people may be reluctant to participate in genetic studies that do whole genome sequencing, for fear their genetic data will not be secure and could be used against them.
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Citing privacy concerns, U.S. panel urges end to secret DNA testing
Myriad's HRD Score Detects Loss of DNA Repair Function in Ovarian Cancer
SALT LAKE CITY, Oct. 10, 2012 (GLOBE NEWSWIRE) -- Myriad Genetics, Inc. (MYGN) announced today that a study published in the British Journal of Cancer demonstrated the ability of the Company's Homologous Recombination Deficiency (HRD) Assay to detect loss of DNA repair in ovarian tumors. The study, entitled, "Patterns of Genomic Loss of Heterozygosity Predict Homologous Recombination Repair Defects in Epithelial Ovarian Cancer," confirmed, with highly statistically significant results, the relationship between Myriad's HRD score and tumors deficient in DNA repair.
"By measuring the HRD score in tumor samples we expect to be able to predict patient response to therapeutic agents that exploit deficiencies in DNA repair," said Jerry Lanchbury Ph.D., Chief Scientific Officer of Myriad Genetics Inc. "Through this best-in-class test we intend to provide patients and their healthcare providers with critical information regarding response to platinum drugs or PARP inhibitors across multiple cancers including breast, ovarian and other cancers."
Researchers at M.D. Anderson Cancer Center, University of California, San Francisco, University of Pittsburgh, University of British Colombia, Royal College of Surgeons in Ireland, and Myriad Genetics generated HRD scores in 639 ovarian tumor samples as well as 57 breast and pancreatic cancer cell lines. The data demonstrated that a high HRD score is highly correlated (p = 1.0 x 10-48) with tumor deficiency in DNA repair.
Hereditary and somatic defects in genes that support homologous recombination have been implicated in predisposition to a variety of cancers. BRCA 1 or BRCA 2 mutations and other HR defects have potential therapeutic relevance when used to direct the use of therapeutics that introduce or exploit double-stranded DNA breaks. Myriad's HRD score could be utilized to identify patients with a variety of cancers who have a high likelihood of responding to DNA damaging agents such as the platinum drugs, as well as PARP inhibitors.
About Myriad Genetics
Myriad Genetics is a leading molecular diagnostic company dedicated to making a difference in patients' lives through the discovery and commercialization of transformative tests to assess a person's risk of developing disease, guide treatment decisions and assess risk of disease progression and recurrence. Myriad's portfolio of molecular diagnostic tests are based on an understanding of the role genes play in human disease and were developed with a commitment to improving an individual's decision making process for monitoring and treating disease. Myriad is focused on strategic directives to introduce new products, including companion diagnostics, as well as expanding internationally. For more information on how Myriad is making a difference, please visit the Company's website: http://www.myriad.com
Myriad, the Myriad logo, BRACAnalysis, Colaris, Colaris AP, Melaris, TheraGuide, Prezeon, OnDose, Panexia and Prolaris are trademarks or registered trademarks of Myriad Genetics, Inc. in the United States and foreign countries. MYGN-G
Safe Harbor Statement
This press release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the Company's expectation to be able to predict patient response to therapeutic agents that exploit deficiencies in DNA repair by measuring the HRD score in tumor samples; the Company's intent to provide patients and their healthcare providers with critical information regarding response to platinum drugs or PARP inhibitors across multiple cancers including breast, ovarian and other cancers; the utility of the Company's HRD score to identify patients with a variety of cancers who have a high likelihood of responding to DNA damaging agents such as the platinum drugs, as well as PARP inhibitors; the potential therapeutic relevance of BRCA1 or BRCA2 and other HR defects to direct the use of therapeutics that introduce or exploit double-stranded DNA breaks; and and the Company's strategic directives under the caption "About Myriad Genetics". These "forward-looking statements" are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by forward-looking statements. These risks and uncertainties include, but are not limited to: the risk that sales and profit margins of our existing molecular diagnostic tests and companion diagnostic services may decline or will not continue to increase at historical rates; the risk that we may be unable to develop or achieve commercial success for additional molecular diagnostic tests and companion diagnostic services in a timely manner, or at all; the risk that we may not successfully develop new markets for our molecular diagnostic tests and companion diagnostic services, including our ability to successfully generate revenue outside the United States; the risk that licenses to the technology underlying our molecular diagnostic tests and companion diagnostic services and any future products are terminated or cannot be maintained on satisfactory terms; risks related to delays or other problems with manufacturing our products or operating our laboratory testing facilities; risks related to public concern over genetic testing in general or our tests in particular; risks related to regulatory requirements or enforcement in the United States and foreign countries and changes in the structure of healthcare payment systems; risks related to our ability to obtain new corporate collaborations or licenses and acquire new technologies or businesses on satisfactory terms, if at all; risks related to our ability to successfully integrate and derive benefits from any technologies or businesses that we license or acquire; the development of competing tests and services; the risk that we or our licensors may be unable to protect the proprietary technologies underlying our tests; the risk of patent-infringement and invalidity claims or challenges of our patents; risks of new, changing and competitive technologies and regulations in the United States and internationally; and other factors discussed under the heading "Risk Factors" contained in Item 1A in our most recent Annual Report on Form 10-K filed with the Securities and Exchange Commission, as well as any updates to those risk factors filed from time to time in our Quarterly Reports on Form 10-Q or Current Reports on Form 8-K. All information in this press release is as of the date of the release, and Myriad undertakes no duty to update this information unless required by law.
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Myriad's HRD Score Detects Loss of DNA Repair Function in Ovarian Cancer
Charter Medical Launches New EXP-Pak(TM) Cell Expansion Containers for Cellular Therapy Applications
MANCHESTER, Conn., Oct. 9, 2012 (GLOBE NEWSWIRE) -- Charter Medical, Ltd., a division of Lydall, Inc., (LDL) announced today that it has recently launched the new EXP-Pak(TM) cell expansion containers intended for the expansion and culture of non-adherent cells. The launch of this exciting new product family allows Charter Medical to provide enabling technology critical to the rapidly growing cellular therapy market. The family of closed-system cell expansion containers offers a broad size range from 500mL to 5L and end-user validated cell expansion rates and recovery.
Joe Petrosky, Vice President of Global Marketing and Sales for Charter Medical, stated, "We are excited with the launch of the EXP-Pak(TM) cell expansion product family. The EXP-Pak(TM) containers complement our closed-system solution approach and play a key role in supporting the development of new cellular therapies."
Dale Barnhart, President and CEO of Lydall, stated, "I am pleased with the launch of this product family for cellular therapy which represents a strategic growth opportunity. It further demonstrates our commitment to being the global supplier of choice as we grow our presence in this emerging segment."
About Lydall, Inc.
Lydall, Inc. is a New York Stock Exchange listed company, headquartered in Manchester, Connecticut. The Company, with operations in the U.S., France, and Germany and offices in Europe and Asia, focuses on specialty engineered products for the thermal/acoustical and filtration/separation markets. Charter Medical, Ltd., a Lydall subsidiary, is a vital fluids management company focused on providing products to separate, contain and transport vital fluids in the blood and cell therapy market and the biotech and pharmaceutical industries. Lydall(R) is a registered trademark of Lydall, Inc. in the U.S. and other countries. All product names are trademarks of Lydall, Inc. or Charter Medical, Ltd.
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Charter Medical Launches New EXP-Pak(TM) Cell Expansion Containers for Cellular Therapy Applications
NeoStem Announces New Publication That Supports Positive Results of AMR-001 for Treatment of AMI
NEW YORK, Oct. 10, 2012 (GLOBE NEWSWIRE) -- NeoStem, Inc. (NBS), an emerging leader in the fast growing cell therapy market, announced today that a new article published by the International Scholarly Research Network provides further evidence that AMR-001, NeoStem's lead product candidate through its Amorcyte subsidiary, appears capable of preserving heart muscle function following a large myocardial infarction. Amorcyte demonstrated in its Phase 1 trial that AMR-001 preserved heart muscle function when a therapeutic dose of cells was administered. No patient experienced a deterioration in heart muscle function who received 10 million cells or more whereas 30 to 40 percent of patients not receiving a therapeutic dose did. The new study shows that cardiac muscle function sparing effects are evident even earlier after treatment than previously shown.
The article titled "Assessment of myocardial contractile function using global and segmental circumferential strain following intracoronary stem cell infusion after myocardial infarction: MRI Feature Tracking Feasibility Study" by Sabha Bhatti, MD, et al. appears in ISRN Radiology Volume 2013, Article ID 371028 and is published online at http://www.isrn.com/journals/radiology/2013/371028. The publication by Dr. Bhatti and colleagues, including Dr. Andrew Pecora, Chief Medical Officer of NeoStem, supports the finding that AMR-001 preserves heart function. Previously, Amorcyte, a NeoStem subsidiary, showed that six months after STEMI AMR-001 improved blood flow to the heart and preserved heart muscle. By using cardiac magnetic resonance imaging, specifically measuring circumferential strain of the left ventricle, the authors show that AMR-001's effects are evident by three months after STEMI.
AMR-001's angiogenic and anti-apoptotic mechanisms of action indicate that preservation of heart muscle function should start within weeks and be evident in fewer than 6 months. This publication, based on blinded analysis of Amorcyte's Phase 1 data, confirms the expected time course for AMR-001's mechanism of action. In the context of previously published results, these effects are durable.
Amorcyte is developing AMR-001, a cell therapy for the treatment of cardiovascular disease, and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving cardiac function and preventing adverse clinical events after a large myocardial infarction.
About NeoStem, Inc.
NeoStem, Inc. continues to develop and build on its core capabilities in cell therapy, capitalizing on the paradigm shift that we see occurring in medicine. In particular, we anticipate that cell therapy will have a significant role in the fight against chronic disease and in lessening the economic burden that these diseases pose to modern society. We are emerging as a technology and market leading company in this fast developing cell therapy market. Our multi-faceted business strategy combines a state-of-the-art contract development and manufacturing subsidiary, Progenitor Cell Therapy, LLC ("PCT"), with a medically important cell therapy product development program, enabling near and long-term revenue growth opportunities. We believe this expertise and existing research capabilities and collaborations will enable us to achieve our mission of becoming a premier cell therapy company.
Our contract development and manufacturing service business supports the development of proprietary cell therapy products. NeoStem's most clinically advanced therapeutic, AMR-001, as mentioned above, is being developed at Amorcyte, LLC ("Amorcyte"), which we acquired in October 2011. Amorcyte is developing a cell therapy for the treatment of cardiovascular disease and is enrolling patients in a Phase 2 trial to investigate AMR-001's efficacy in preserving heart function after a heart attack. Athelos Corporation ("Athelos"), which is approximately 80%-owned by our subsidiary, PCT, is collaborating with Becton-Dickinson in the early clinical exploration of a T-cell therapy for autoimmune conditions. In addition, pre-clinical assets include our VSELTM Technology platform as well as our mesenchymal stem cell product candidate for regenerative medicine. Our service business and pipeline of proprietary cell therapy products work in concert, giving us a competitive advantage that we believe is unique to the biotechnology and pharmaceutical industries. Supported by an experienced scientific and business management team and a substantial intellectual property estate, we believe we are well positioned to succeed.
Forward-Looking Statements for NeoStem, Inc.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management's current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company's business strategy, including with respect to the Company's or its partners' successful development of AMR-001 and other cell therapeutics, the size of the market for such products, its competitive position in such markets, the Company's ability to successfully penetrate such markets and the market for its CDMO business, and the efficacy of protection from its patent portfolio, as well as the future of the cell therapeutics industry in general, including the rate at which such industry may grow. Forward looking statements also include statements with respect to satisfying all conditions to closing the disposition of Erye, including receipt of all necessary regulatory approvals in the PRC. The Company's actual results could differ materially from those anticipated in these forward- looking statements as a result of various factors, including but not limited to (i) the Company's ability to manage its business despite operating losses and cash outflows, (ii) its ability to obtain sufficient capital or strategic business arrangement to fund its operations, including the clinical trials for AMR-001, (iii) successful results of the Company's clinical trials of AMR-001 and other cellular therapeutic products that may be pursued, (iv) demand for and market acceptance of AMR-001 or other cell therapies if clinical trials are successful and the Company is permitted to market such products, (v) establishment of a large global market for cellular-based products, (vi) the impact of competitive products and pricing, (vii) the impact of future scientific and medical developments, (viii) the Company's ability to obtain appropriate governmental licenses and approvals and, in general, future actions of regulatory bodies, including the FDA and foreign counterparts, (ix) reimbursement and rebate policies of government agencies and private payers, (x) the Company's ability to protect its intellectual property, (xi) the company's ability to successfully divest its interest in Erye, and (xii) matters described under the "Risk Factors" in the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 20, 2012 and in the Company's other periodic filings with the Securities and Exchange Commission, all of which are available on its website. The Company does not undertake to update its forward-looking statements. The Company's further development is highly dependent on future medical and research developments and market acceptance, which is outside its control.
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NeoStem Announces New Publication That Supports Positive Results of AMR-001 for Treatment of AMI
RMND1 mutation: Scientists discover gene behind rare disorders
ScienceDaily (Oct. 9, 2012) Scientists at the Montreal Neurological Institute and Hospital -- The Neuro, McGill University working with a team at Oxford University have uncovered the genetic defect underlying a group of rare genetic disorders.
Using a new technique that has revolutionized genetic studies, the teams determined that mutations in the RMND1 gene were responsible for severe neurodegenerative disorders, in two infants, ultimately leading to their early death. Although the teams' investigations dealt with an infant, their discovery also has implications for understanding the causes of later-onset neurological diseases.
The RMND1 gene encodes a protein that is an important component of the machinery in mitochondria which generates the chemical energy that all cells need to function. Mutations in genes affecting mitochondrial function are common causes of neurological and neuromuscular disorders in adults and children. It is estimated that one newborn baby out of 5000 is at risk for developing one of these disorders. Mortality among such cases is very high.
"Mitochondria are becoming a focus of research because it's clear they're involved in neurodegenerative disorders in a fairly big way," says Dr. Eric Shoubridge, an internationally recognized specialist on mitochondrial diseases at The Neuro and lead author of the paper published in The American Journal of Human Genetics. "For instance, we're finding that dysfunctional mitochondria may be at the heart of adult-onset disorders like Parkinson's and Alzheimer's disease."
Discovery of the mutations in the RMND1 gene involved using whole-exome sequencing at the McGill University and Genome Qubec Innovation Centre. This technique allows all of the genes in the body that code for proteins to be sequenced and analyzed in a single experiment. At a cost of about $1000, whole-exome sequencing is much more economical than previous techniques in which lists of candidate genes had to be screened in the search for mutations. The technique is poised to change the face of genetic diagnosis, making testing more efficient and available.
"Parents who have had a child with a mitochondrial disorder and who are hesitating to have another child now have the possibility to know the cause of the disease. With genetic information, they have reproductive options like in vitro fertilization," says Dr. Shoubridge. The discovery of the RMND1 gene's role sheds light on disorders of mitochondrial energy metabolism, but therapies to alleviate or cure such disorders remain elusive. Dr. Shoubridge is hopeful that the discovery will encourage pharmaceutical interest. "Drug companies are starting to be interested in rare diseases and metabolic disorders like this. They're picking some genes as potential drug candidates."
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The above story is reprinted from materials provided by McGill University, via EurekAlert!, a service of AAAS.
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RMND1 mutation: Scientists discover gene behind rare disorders
'Barcode' blood test for aggressive prostate cancer developed
ScienceDaily (Oct. 9, 2012) Scientists have designed a blood test that reads genetic changes like a barcode -- and can pick out aggressive prostate cancers by their particular pattern of gene activity.
A team at The Institute of Cancer Research, London, and The Royal Marsden NHS Foundation Trust found reading the pattern of genes switched on and off in blood cells could accurately detect which advanced prostate cancers had the worst survival.
And the researchers believe the blood test could eventually be used alongside the existing PSA test at diagnosis to select patients who need immediate treatment.
The test, described in The Lancet Oncology today (Oct. 9), is unique because it assesses changes in the pattern of gene activity in blood cells triggered by a tumour elsewhere in the body.
Lead author Professor Johann de Bono, leader of the prostate cancer targeted therapy team at The Institute of Cancer Research (ICR), and honorary consultant at The Royal Marsden NHS Foundation Trust, said: "Prostate cancer is a very diverse disease -- some people live with it for years without symptoms but for others it can be aggressive and life-threatening -- so it's vital we develop reliable tests to tell the different types apart.
"We've shown it is possible to learn more about prostate cancers by the signs they leave in the blood, allowing us to develop a test that is potentially more accurate than those available now and easier for patients than taking a biopsy. Our test reads the pattern of genetic activity like a barcode, picking up signs that a patient is likely to have a more aggressive cancer. Doctors should then be able to adjust the treatment they give accordingly."
Researchers scanned all the genes present in blood samples from 100 patients with prostate cancer at the ICR's and The Royal Marsden's joint Drug Development Unit in London and The Beatson West of Scotland Cancer Centre in Glasgow. They included 69 patients with advanced cancer and 31 control patients thought to have low-risk, early-stage cancer, who were being managed by active surveillance.
Using statistical modelling, they divided the patients into four groups reflecting their pattern of gene activity -- the barcode. When they reviewed all the patients' progress after almost two-and-a-half years, they found patients in one group had survived for significantly less time than patients in the others. Further modelling identified nine key active genes that were shared by all patients in the group.
They confirmed the results in another 70 US patients with advanced cancer, showing that just these nine genes could be used to accurately identify those who ultimately survived for a shorter time -- 9.2 months compared with 21.6 months for patients without the gene pattern. The genes included a number involved in the immune system -- suggesting the immune system was suppressed in patients whose cancers were spreading around the body.
Professor Alan Ashworth, chief executive of The Institute of Cancer Research, said: "Whether particular genes are active or not is an important clue in identifying patients with a poor prognosis. This latest study shows that it is possible to read these patterns of gene activity like a barcode, allowing scientists to spot cancers that are likely to be more aggressive."
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'Barcode' blood test for aggressive prostate cancer developed
Thermo Fisher creates mobile app for gene researchers
Thermo Fisher Scientific has created a new mobile app for researchers.
Scientists and students alike can now search research and news articles relating to gene and protein research thanks to a new mobile app created and offered by Thermo Fisher Scientific Inc. (NYSE: TMO).
The Waltham scientific instruments and services provider developed the free Gene News mobile app for iPhone and Android devices to give researchers access to gene research so that they spend less time searching for articles and more time in the lab, Thermo Fisher said Tuesday.
Thermo Fisher Scientific has been very active across the business units with developing and launching mobile apps, according to Neal Kitchen, a product manager at Thermo Scientific Pierce Protein Research.
"Smartphones have become very important resource tools in the lab for researchers," Kitchen said. "So, we wanted to develop a science-focused app that helped researchers easily navigate and manage the constant stream of new information found daily in publications, patents, and the news."
"The Thermo Scientific Gene News App was designed for this purpose. As we were developing the app, it was such a useful and convenient tool for our own scientists that we knew it would be even more functional for the rest of the science community, he added.
The app allows students and researchers to:
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Thermo Fisher creates mobile app for gene researchers
Gene 'barcode' scans men for prostate cancer
Doctors may soon use a new genetic "barcode" blood test - besides normal screening - to determine how severe a man's prostate cancer is and how urgently it should be treated.
Researchers in Britain have discovered distinct genetic signatures for prostrate cancer and designed an experimental blood test that reads the genetic changes like a barcode.
The researchers say the blood test could be used alongside existing PSA (Prostate-Specific Antigen) screening to determine which men need more aggressive or immediate treatment.
Screening and biopsies
For most men, however, screening often leads to biopsies, which are currently the only way to predict the aggressiveness of prostrate cancer. But biopsies are invasive and carry potential complications, according to Johann de Bono, head of the prostate cancer research team at The Institute of Cancer Research (ICR) in London.
A blood test, he argues, would be much easier for patients and potentially more accurate, and would allow their cancer to be assessed throughout treatment.
"It can also give information that a biopsy can't, like how a patient's immune system can [influence] survival," de Bono says.
Prostate cancer is the second most common cancer in men after lung cancer.
De Bono refers to prostate cancer as a "very diverse disease."He says some people can live with it for years without any symptoms, while others find themselves confronted with an aggressive, life-threatening form.
Distinguishing different types
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Gene 'barcode' scans men for prostate cancer
Thermo Fisher Scientific Introduces Free Smartphone App For Gene Research
ROCKFORD, Ill.--(BUSINESS WIRE)--
Thermo Fisher Scientific Inc., the world leader in serving science, today introduced the free Thermo Scientific Gene News mobile App for iPhone and Android devices, giving researchers unmatched access to important gene research in the palms of their hands. Scientists can spend less time searching for relevant information and more time on productive research.
More than ever, students, scientists and researchers are turning to smartphones to search for the latest research data, said Jeff Lee, commercial director for immunoassay products, Thermo Fisher Scientific. The Thermo Scientific Gene News App makes it even easier and more convenient to access information that is relevant to their work. Researchers have the freedom to search an area of interest down to a specific gene or protein. The easy-to-use interface and the ability to share the content through email or social media ensure the app is a powerful tool in the laboratory.
The Thermo Scientific Gene News App allows researchers to monitor articles and news related to their specific areas of interest through their smartphones, and also gives them the ability to: Access up-to-date gene research in an easy-to-read format Customize and bookmark search inquiries Save articles to read at a later time Personalize user preferences such as sorting searches by publication date, journal title, author and/or publication impact Search by keyword and preferred journals Share articles with friends and colleagues via email or social media (Facebook, Twitter)
The Thermo Scientific Gene News App is compatible with iPhone and Android platforms and is available now. Download the Gene News App for iPhone or the Gene News App for Android.
About Thermo Fisher Scientific Thermo Fisher Scientific Inc. is the world leader in serving science. Our mission is to enable our customers to make the world healthier, cleaner and safer. With revenues of $12 billion, we have approximately 39,000 employees and serve customers within pharmaceutical and biotech companies, hospitals and clinical diagnostic labs, universities, research institutions and government agencies, as well as in environmental and process control industries. We create value for our key stakeholders through three premier brands, Thermo Scientific, Fisher Scientific and Unity Lab Services, which offer a unique combination of innovative technologies, convenient purchasing options and a single solution for laboratory operations management. Our products and services help our customers solve complex analytical challenges, improve patient diagnostics and increase laboratory productivity. Visit http://www.thermofisher.com.
Copyright 2012 Business Wire All Rights Reserved.
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Thermo Fisher Scientific Introduces Free Smartphone App For Gene Research
A Welcome Predictability
Berkeley Lab Researchers Develop New Tool for Making Genetic Engineering of Microbial Circuits Reliably Predictable
Synthetic biology is the latest and most advanced phase of genetic engineering, holding great promise for helping to solve some of the world's most intractable problems, including the sustainable production of energy fuels and critical medical drugs, and the safe removal of toxic and radioactive waste from the environment. However, for synthetic biology to reach its promise, the design and construction of biological systems must be as predictable as the assembly of computer hardware.
An important step towards attaining a higher degree of predictability in synthetic biology has been taken by a group of researchers with the U.S. Department of Energy's Lawrence Berkeley National Laboratory (Berkeley Lab) under the leadership of computational biologist Adam Arkin. Arkin and his team have developed an "adaptor" that makes the genetic engineering of microbial components substantially easier and more predictable by converting regulators of translation into regulators of transcription in Escherichia coli. Transcription and translation make up the two-step process by which the coded instructions of genes are used to synthesize proteins.
"Application of our adaptor should produce large collections of transcriptional regulators whose inherent composability can facilitate the predictable engineering of complex biological circuits in microorganisms," Arkin says. "This in turn should allow for safer and more efficient constructions of increasingly complex functions in microorganisms."
Arkin is the director of Berkeley Lab's Physical Biosciences Division and the corresponding author of a paper describing this work in Nature Methods. The paper is titled "An adaptor from translational to transcriptional control enables predictable assembly of complex regulation. Co-authoring this paper were Chang Liu, Lei Qi, Julius Lucks, Thomas Segall-Shapiro, Denise Wang and Vivek Mutalik.
Synthetic biology combines modern principles of science and engineering to develop novel biological functions and systems that can tackle problems natural systems cannot. The focus is on bacteria and other microbes that can metabolize a wide variety of valuable chemicals and molecules, and play a critical role in the global cycles of carbon and other important elements. One of the keys to success in synthetic biology is the design and construction of customized genetic switches in microbes that can control the expression of both coding and non-coding RNA, act on operons (small groups of genes with related functions that are co-transcribed in a single strand of messenger RNA), and be tethered to higher-order regulatory functions (a property called composability).
"Much of the regulatory potential of a bacterium is contained in the five-prime untranslated regions (UTRs), which control the expression of physically adjacent downstream genes and have become attractive platforms for a parts-based approach to synthetic biology," Arkin says. "This approach, in which integrated engineered regulatory parts respond to custom inputs by changing the expression of desired genes, must satisfy two criteria if it is to have long-term success. First, the regulatory parts must be easily engineered in a way that yields large homogenous sets of variants that respond to different custom inputs, and second, the parts must be composable such that they can be easily and predictably assembled into useful higher-order functions."
In the five prime UTRs of bacteria, two primary types of regulators can serve as starting points for designing new parts - those that regulate transcriptional elongation, in which cellular inputs are linked to the process by which a sequence of DNA nucleotides is transcribed into a complementary sequence of RNA; and those that regulate translation, in which a ribosome translates the RNA message into a protein. Transcriptional elongation regulators meet the second criterion by featuring versatility and composability that makes them ideal for building custom regulatory functions. Translational regulators meet the first criterion by being easier to engineer and relatively common to all bacteria.
"Our solution for meeting both criteria was to develop an adaptor based on tryptophanase, the catabolic operon for tryptophan that converts regulators of translational initiation into regulators of transcriptional elongation," Arkin says. "Because our adaptor strategy bypasses the otherwise restrictive tradeoff between criterion one and criterion two, we believe it will have a crucial role in the long-term development of five prime UTRs as platforms for the design and integration of custom regulatory parts."
When an E.coli translational regulator was fused to the adaptor created by Arkin and his colleagues, it was also able to control transcriptional elongation. The team applied their adaptor to the construction of several transcriptional elongation regulators that respond to RNA and small-molecule inputs. Included were five mutually orthogonal RNA-triggered attenuators (meaning they can terminate transcription), which the team assembled into logic gates driven by two, three or four RNA inputs that linked to ribosome binding sites. Because their adaptor is so easily linked to ribosome binding sites, a common mechanism in bacteria, the team believes the adaptor will be widely applicable.
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A Welcome Predictability
Researchers develop new tool for making genetic engineering of microbial circuits reliably predictable
Fluorescence microscopy images of cells containing various plasmid pairs which were constructed with the help of a tna element adaptor and logic gates driven by two, three or four RNA inputs that linked to ribosome binding sites.
(Phys.org)Synthetic biology is the latest and most advanced phase of genetic engineering, holding great promise for helping to solve some of the world's most intractable problems, including the sustainable production of energy fuels and critical medical drugs, and the safe removal of toxic and radioactive waste from the environment. However, for synthetic biology to reach its promise, the design and construction of biological systems must be as predictable as the assembly of computer hardware.
An important step towards attaining a higher degree of predictability in synthetic biology has been taken by a group of researchers with the U.S. Department of Energy's Lawrence Berkeley National Laboratory (Berkeley Lab) under the leadership of computational biologist Adam Arkin. Arkin and his team have developed an "adaptor" that makes the genetic engineering of microbial components substantially easier and more predictable by converting regulators of translation into regulators of transcription in Escherichia coli. Transcription and translation make up the two-step process by which the coded instructions of genes are used to synthesize proteins.
"Application of our adaptor should produce large collections of transcriptional regulators whose inherent composability can facilitate the predictable engineering of complex biological circuits in microorganisms," Arkin says. "This in turn should allow for safer and more efficient constructions of increasingly complex functions in microorganisms."
Arkin is the director of Berkeley Lab's Physical Biosciences Division and the corresponding author of a paper describing this work in Nature Methods. The paper is titled "An adaptor from translational to transcriptional control enables predictable assembly of complex regulation. Co-authoring this paper were Chang Liu, Lei Qi, Julius Lucks, Thomas Segall-Shapiro, Denise Wang and Vivek Mutalik.
Enlarge
When a bacterial translational regulator is fused to a tna element adaptor, it is able to also regulate transcriptional elongation.
"Much of the regulatory potential of a bacterium is contained in the five-prime untranslated regions (UTRs), which control the expression of physically adjacent downstream genes and have become attractive platforms for a parts-based approach to synthetic biology," Arkin says. "This approach, in which integrated engineered regulatory parts respond to custom inputs by changing the expression of desired genes, must satisfy two criteria if it is to have long-term success. First, the regulatory parts must be easily engineered in a way that yields large homogenous sets of variants that respond to different custom inputs, and second, the parts must be composable such that they can be easily and predictably assembled into useful higher-order functions."
In the five prime UTRs of bacteria, two primary types of regulators can serve as starting points for designing new parts those that regulate transcriptional elongation, in which cellular inputs are linked to the process by which a sequence of DNA nucleotides is transcribed into a complementary sequence of RNA; and those that regulate translation, in which a ribosome translates the RNA message into a protein. Transcriptional elongation regulators meet the second criterion by featuring versatility and composability that makes them ideal for building custom regulatory functions. Translational regulators meet the first criterion by being easier to engineer and relatively common to all bacteria.
"Our solution for meeting both criteria was to develop an adaptor based on tryptophanase, the catabolic operon for tryptophan that converts regulators of translational initiation into regulators of transcriptional elongation," Arkin says. "Because our adaptor strategy bypasses the otherwise restrictive tradeoff between criterion one and criterion two, we believe it will have a crucial role in the long-term development of five prime UTRs as platforms for the design and integration of custom regulatory parts."
Excerpt from:
Researchers develop new tool for making genetic engineering of microbial circuits reliably predictable
New tool for making genetic engineering of microbial circuits reliably predictable
ScienceDaily (Oct. 8, 2012) Synthetic biology is the latest and most advanced phase of genetic engineering, holding great promise for helping to solve some of the world's most intractable problems, including the sustainable production of energy fuels and critical medical drugs, and the safe removal of toxic and radioactive waste from the environment. However, for synthetic biology to reach its promise, the design and construction of biological systems must be as predictable as the assembly of computer hardware.
An important step towards attaining a higher degree of predictability in synthetic biology has been taken by a group of researchers with the U.S. Department of Energy's Lawrence Berkeley National Laboratory (Berkeley Lab) under the leadership of computational biologist Adam Arkin. Arkin and his team have developed an "adaptor" that makes the genetic engineering of microbial components substantially easier and more predictable by converting regulators of translation into regulators of transcription in Escherichia coli. Transcription and translation make up the two-step process by which the coded instructions of genes are used to synthesize proteins.
"Application of our adaptor should produce large collections of transcriptional regulators whose inherent composability can facilitate the predictable engineering of complex biological circuits in microorganisms," Arkin says. "This in turn should allow for safer and more efficient constructions of increasingly complex functions in microorganisms."
Arkin is the director of Berkeley Lab's Physical Biosciences Division and the corresponding author of a paper describing this work in Nature Methods. The paper is titled "An adaptor from translational to transcriptional control enables predictable assembly of complex regulation. Co-authoring this paper were Chang Liu, Lei Qi, Julius Lucks, Thomas Segall-Shapiro, Denise Wang and Vivek Mutalik.
Synthetic biology combines modern principles of science and engineering to develop novel biological functions and systems that can tackle problems natural systems cannot. The focus is on bacteria and other microbes that can metabolize a wide variety of valuable chemicals and molecules, and play a critical role in the global cycles of carbon and other important elements. One of the keys to success in synthetic biology is the design and construction of customized genetic switches in microbes that can control the expression of both coding and non-coding RNA, act on operons (small groups of genes with related functions that are co-transcribed in a single strand of messenger RNA), and be tethered to higher-order regulatory functions (a property called composability).
"Much of the regulatory potential of a bacterium is contained in the five-prime untranslated regions (UTRs), which control the expression of physically adjacent downstream genes and have become attractive platforms for a parts-based approach to synthetic biology," Arkin says. "This approach, in which integrated engineered regulatory parts respond to custom inputs by changing the expression of desired genes, must satisfy two criteria if it is to have long-term success. First, the regulatory parts must be easily engineered in a way that yields large homogenous sets of variants that respond to different custom inputs, and second, the parts must be composable such that they can be easily and predictably assembled into useful higher-order functions."
In the five prime UTRs of bacteria, two primary types of regulators can serve as starting points for designing new parts -- those that regulate transcriptional elongation, in which cellular inputs are linked to the process by which a sequence of DNA nucleotides is transcribed into a complementary sequence of RNA; and those that regulate translation, in which a ribosome translates the RNA message into a protein. Transcriptional elongation regulators meet the second criterion by featuring versatility and composability that makes them ideal for building custom regulatory functions. Translational regulators meet the first criterion by being easier to engineer and relatively common to all bacteria.
"Our solution for meeting both criteria was to develop an adaptor based on tryptophanase, the catabolic operon for tryptophan that converts regulators of translational initiation into regulators of transcriptional elongation," Arkin says. "Because our adaptor strategy bypasses the otherwise restrictive tradeoff between criterion one and criterion two, we believe it will have a crucial role in the long-term development of five prime UTRs as platforms for the design and integration of custom regulatory parts."
When an E.coli translational regulator was fused to the adaptor created by Arkin and his colleagues, it was also able to control transcriptional elongation. The team applied their adaptor to the construction of several transcriptional elongation regulators that respond to RNA and small-molecule inputs. Included were five mutually orthogonal RNA-triggered attenuators (meaning they can terminate transcription), which the team assembled into logic gates driven by two, three or four RNA inputs that linked to ribosome binding sites. Because their adaptor is so easily linked to ribosome binding sites, a common mechanism in bacteria, the team believes the adaptor will be widely applicable.
"Continued application of our adaptor should produce large collections of transcriptional regulators whose inherent composability can facilitate the predictable engineering of complex synthetic circuits," Arkin says.
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New tool for making genetic engineering of microbial circuits reliably predictable
‘Barcode’ Blood Test Reads Genetic Results, Helps Detect Aggressive Prostate Cancer
Lawrence LeBlond for redOrbit.com Your Universe Online
A blood test that can read genetic results much like a barcode has been developed by scientists at the Institute of Cancer Research (ICR) and the Royal Marsden NHS Foundation. This genetic blood test can also detect the most aggressive prostate cancers by reading particular patterns of gene activity.
Research staff believe the test could eventually be used to select patients who are most in need of immediate treatment. Prostate cancer is a very diverse disease. Some people live with it for years without any symptoms, but in others, the disease can be very aggressive and life-threatening, said lead author of the study, Professor Johann de Bono, of ICR, and an honorary consultant at Royal Marsden.
Current cancer screening tests include a biopsy, where doctors take a small sample of a tumor and examine it under a microscope to find out how dangerous it may be. Experts hope that the new barcode test will ultimately lead to more accurate estimations without invasive biopsy screenings. The researchers also believe the barcode test could be used in conjunction with current PSA screenings to select patients who are in dire need of treatment.
Described in The Lancet Oncology medical journal, the test is unique because it can assess changes in the pattern of gene activity in blood cells triggered by a tumor found elsewhere in the body.
Weve shown it is possible to learn more about prostate cancers by the signs they leave in the blood, allowing us to develop a test that is potentially more accurate than those available now and easier for patients than taking a biopsy. Our test reads the pattern of genetic activity like a barcode, picking up signs that a patient is likely to have a more aggressive cancer. Doctors should then be able to adjust the treatment they give accordingly, said de Bono.
In the trial, de Bono and colleagues scanned all the genes present in blood samples of 100 patients with prostate cancer at the Drug Development Unit in London and The Beatson West of Scotland Cancer Centre in Glasgow. The trial included 69 patients with advanced prostate cancer and 31 control patients with low-risk, early-stage cancer.
The team divided the patients into four groups reflecting their pattern of gene activitythe barcode. After reviewing all the patients progress over nearly 30 months, the researchers found patients in one group had survived for significantly less time than patients in others. Further modeling identified nine key active genes shared by all patients in the group.
The researchers then compared the results with another group of 70 US patients with advanced cancer. What they found is that these nine genes could be used to accurately identify those who survived for a shorter period9.2 months compared with 21.6 months for patients without the gene pattern. The findings suggest a number of the genes actually suppressed the immune system in patients whose cancers were spreading.
Whether particular genes are active or not is an important clue in identifying patients with a poor prognosis. This latest study shows that it is possible to read these patterns of gene activity like a barcode, allowing scientists to spot cancers that are likely to be more aggressive, said Professor Alan Ashworth, chief executive of The Institute of Cancer Research.
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‘Barcode’ Blood Test Reads Genetic Results, Helps Detect Aggressive Prostate Cancer
Prostate Cancer Severity Predicted With Two Genetic Signatures
Editor's Choice Academic Journal Main Category: Prostate / Prostate Cancer Also Included In: Genetics Article Date: 09 Oct 2012 - 0:00 PDT
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The authors explain that unique RNA patterns seem to be able to predict the course of prostate cancer, pointing either towards an aggressive disease or a milder form. RNA (ribonucleic acid) is the genetic material that helps convert DNA into proteins.
Prostate cancer affects patients in many different ways. Some develop the disease and do not know because they have no symptoms, some may respond extremely well to treatment, while others have types that resist all treatment and progress regardless.
Castration-resistant prostate cancer does not respond to standard androgen deprivation therapy. Survival times with this type of cancer vary considerably from patient-to-patient. Nobody really knows why.
Current diagnostic tests can tell, to a certain extent, whether or not a prostate cancer is likely to be an aggressive one. However, their accuracy can only be described as "moderate".
A distinctive nine-gene pattern which was linked to castration-resistant prostate cancer patients was accurately detected - those patients survived for an average of 9.2 months after referral for treatment, compared to those without the genetic pattern who survived for 21.6 months.
They identified a set of six genes linked to an aggressive form of prostate cancer in 62 patients at the Dana-Farber Cancer Institute, Boston, USA.
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Prostate Cancer Severity Predicted With Two Genetic Signatures