Archive for the ‘Gene Therapy Research’ Category

Public release date: 6-Aug-2012 [ | E-mail | Share ]

Contact: Mike Sepanic msepanic@camden.rutgers.edu 856-225-6026 Rutgers University

CAMDEN A top national award for promising research scientists has been presented to Princeton resident Nir Yakoby, an assistant professor of biology at Rutgers UniversityCamden.

Yakoby has received a prestigious CAREER Award from the National Science Foundation. The five-year, $686,544 award, which is reviewed and renewed annually based on the scientific progress of the project, supports the RutgersCamden researcher's project "Dynamics and Diversity of Bone Morphogenetic Protein Signaling in Epithelial Cells."

The grant will allow Yakoby and his research lab team to study the processes that occur during the time that cells decide what to become. RutgersCamden student researchers will join Yakoby in using the fruit fly Drosophila as an experimental system to study how very similar layers of cells produce different numbers of tubes. Through this work, the RutgersCamden researcher will seek to understand how changes in the bone morphogenetic protein (BMP) signal create different morphologies.

In explaining his research, Yakoby posits the following questions: "Why do we have two arms and two legs and not three of each? Why do we have five fingers and not six?" The RutgersCamden researcher seeks to find those answers by examining the signals and processes that advise cells as they form organs.

"These questions are particularly intriguing since the cells in the human body all contain the same genetic information. However, the clear cells in the eyes' corneas are obviously very different from the cells that secrete insulin in the pancreas," notes Yakoby.

A major goal of the NSF CAREER Award is to integrate academic teaching with research in the lab. RutgersCamden students will participate in this research.

In the Yakoby Lab, RutgersCamden students use the fruit fly Drosophila as an experimental system to study how a layer of cells in the fly ovaries form an eggshell. The eggshell protects the developing embryo from the dry environment while allowing for respiration through tube-like snorkels called dorsal appendages (DAs). Just as animals have different numbers of fingers, the numbers of the eggshells' respiratory tubes differ among Drosophila species. Thus, the eggshell provides a unique opportunity to study how very similar layers of cells produce different numbers of tubes.

In humans, a signal named the bone morphogenetic protein (BMP) is necessary to define the development of fingers. The same signal controls the formation of the DAs on the Drosophila eggshell. Through his CAREER Award, Yakoby proposes to study how changes in the BMP signal allow for the formation of different numbers of DAs. Since the BMP signal is highly conserved between Drosophila and humans, understanding how changes in this signal create different morphologies will help to understand tissue pathologies and developmental defects which are associated with mal-regulation of the BMP signal.

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Rutgers-Camden genetics researcher receives NSF CAREER Award

LOS ANGELES, Aug. 7, 2012 /PRNewswire/ --Response Genetics, Inc. (RGDX), a company focused on the development and commercialization of molecular diagnostic tests for cancer, will announce its second quarter financial results and give an operational update in a press release to be issued before the market opens on Tuesday, August 14, 2012. The company will host a conference call that same day at 10:00 a.m. EDT to discuss its financial results.

Conference Call Details

To access the conference call by phone on August 14 at 10:00 a.m. EDT, dial (800) 537-0745 or (253) 237-1142 for international participants. A telephone replay will be available beginning approximately two hours after the call through August 21, 2012 and may be accessed by dialing (855) 859-2056 or (404) 537-3406. The conference passcode for both the live call and replay is 18367261.

To access the live and archived webcast of the conference call, go to the Investor Relations section of the company's Web site at http://investor.responsegenetics.com. It is advised that participants connect at least 15 minutes prior to the call to allow for any software downloads that might be necessary.

About Response Genetics, Inc.

Response Genetics Inc. (the "Company") is a CLIA-certified clinical laboratory focused on the development and sale of molecular diagnostic tests for cancer. The Company's principal customers include oncologists, pathologists and hospitals. In addition to diagnostic testing services, the Company generates revenue from the sale of its analytical testing services of clinical trial specimens to the pharmaceutical industry. The Company's headquarters is located in Los Angeles, California. For additional information, please visit http://www.responsegenetics.com.

Forward-Looking Statement Notice

Except for the historical information contained herein, this press release and the statements of representatives of the Company related thereto contain or may contain, among other things, certain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995.

Such forward-looking statements involve significant risks and uncertainties. Such statements may include, without limitation, statements with respect to the Company's plans, objectives, projections, expectations and intentions, such as the ability of the Company to continue to provide clinical testing services to the medical community, to continue to expand its sales force, to continue to build its digital pathology initiative, to attract and retain qualified management, to strengthen marketing capabilities, to expand the suite of ResponseDX products, to continue to provide clinical trial support to pharmaceutical clients, to enter into new collaborations with pharmaceutical clients, to enter into new areas such as companion diagnostics, to continue to execute on its business strategy and operations, to continue to analyze cancer samples, and the potential for using the results of this research to develop diagnostic tests for cancer, the usefulness of genetic information to tailor treatment to patients, and other statements identified by words such as "projects," "may," "could," "would," "should," "believes," "expects," "anticipates," "estimates," "intends," "plans" or similar expressions.

These statements are based upon the current beliefs and expectations of the Company's management and are subject to significant risks and uncertainties, including those detailed in the Company's filings with the Securities and Exchange Commission. Actual results, including, without limitation, actual sales results, if any, or the application of funds, may differ from those set forth in the forward-looking statements. These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company's control). The Company undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise, except as required by law.

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Response Genetics, Inc. to Release Second Quarter Financial Results and Host Conference Call on August 14, 2012

Sigma-Aldrich Corporation (SIAL) recently announced that Sigma Advanced Genetic Engineering (:SAGE) Labs, an initiative of Sigma Life Science, has extended its partnership with Autism Speaks to develop the first rat models with modified autism associated genes to enhance discovery and translational autism research. Autism Speaks is the biggest autism science and advocacy organization in the U.S.

Extension of the existing partnership between Sigma and Autism Speaks was on the heels of some behavioral studies, which revealed that the first two publicly available gene-knockout rats display unique characteristics of autism like social deficits and repetitive behaviors. Autism Spectrum Disorder can be experimented on animals to better study its cause and treat the individuals suffering from the disorder. SAGE labs and Autism Speaks are set to generate genetically modified rat models of key autism-associated genes, including CNTNAP2 and MET. CNTNAP2 and MET are knockout rat lines and are expected to be available in 2013. The expanded collaboration will ensure that new models are developed and are made available to speed up the translational research continuum.

Sigma Life Science is the biological products and services arm of Sigma-Aldrich Corporation. Sigma-Aldrich, a life-science and specialty chemical company, released its second-quarter 2012 earnings last month.

The company posted adjusted earnings of 97 cents per share in the quarter, in line with the Zacks Consensus Estimate but ahead of the year-ago earnings of 93 cents per share. Profit, as reported, marginally increased to $115 million or 94 cents per share in the quarter from $113 million or 91 cents a year ago.

Revenues came in at $664 million in the quarter, up 4% year over year but below the Zacks Consensus Estimate of $673 million. Acquisitions contributed 6% to the growth while foreign exchange translation had an unfavorable impact of 5%. The company saw growth across its Research Chemicals and Fine Chemicals (SAFC) divisions.

Moving ahead, Sigma-Aldrich expects organic growth to be in low-to-mid single digits in 2012, down from the earlier expectation of mid single-digits. Macroeconomic uncertainties may hinder its Research Chemicals business whereas growth in Bioscience and Hitech is expected to drive SAFC sales for the remainder of the year. The acquisitions of BioReliance and Research Organics are expected to boost sales by 6%.

Sigma-Aldrich currently maintains a Zacks #4 Rank, which translates into a short-term (1 to 3 months) Sell rating. We have a long-term Neutral recommendation on the stock.

Zacks Investment Research

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Sigma Expands Autism Collaboration

Youre at the supermarket doing your grocery shopping. As you move up and down the aisles, you notice something different: new labels on several of your staple food items. Pasta, cereal, chips, sweet corn and yellow squash all now have a distinct marking that says either genetically engineered or partially produced with genetic engineering.

How might this change your food choices?

In November, voters will have a chance to decide whether such information must be labeled on food products under Proposition 37. If passed, it would be the first such law in the U.S.

We dont know how or if it will change consumers approach to eating, said Lori Sinsley, deputy director of the California Right to Know Campaign. They can use the labels to make more informed choices about what they eat, which is how a market is supposed to work.

Genetically modified organisms, or GMOs, are crops that have had their DNA artificially altered with genes from plants, animals, viruses or bacteria. This type of genetic modification occurs in a laboratory and cannot be found in nature, Sinsley said.

Many processed foods are made with genetically engineered ingredients whether shoppers know it or not. Processed items commonly contain genetically modified corn, sweet corn, soy and canola. Even common produce items such as yellow squash, zucchini and papaya are genetically modified, as well as other crops such as cotton.

It is our fundamental right to know what is in our food, said Zuri Allen, social media coordinator for both Right to Know and the Organic Consumers Association. Its as American as apple pie.

There are exemptions in the initiative food derived entirely from an animal that hasnt been genetically engineered itself, regardless of the animals possible consumption of genetically modified foods; alcoholic beverages; and food intended for immediate consumption (as in restaurants). Producers of foods that are fully or partially genetically engineered and are not exempt would not be able to advertise their products as natural or naturally made.

I have children and I know that I have a right to know what Im buying and feeding to my family, said Susan Lang, a volunteer for Right to Know and co-leader of the Sacramento County group Label GMOs. California voters really need to ask themselves why the opposition doesnt want them to know whats in their food.

While genetic engineering can sound scary, its important to know that these foods are not made in a lab, said Stop the Costly Food Labeling Proposition spokeswoman Kathy Fairbanks. The seeds are genetically altered to use water more efficiently and resist pests. Some foods, such as the papaya, are genetically engineered to survive devastating diseases.

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Difficult choices in the produce aisle

Newswise August 6, 2012 (Bronx, NY) A new genetic analysis focusing on Jews from North Africa has provided an overall genetic map of the Jewish Diasporas. The findings support the historical record of Middle Eastern Jews settling in North Africa during Classical Antiquity, proselytizing and marrying local populations, and, in the process, forming distinct populations that stayed largely intact for more than 2,000 years. The study, led by researchers at Albert Einstein College of Medicine of Yeshiva University, was published online today in the Proceedings of the National Academy of Sciences.

Our new findings define North African Jews, complete the overall population structure for the various groups of the Jewish Diaspora, and enhance the case for a biological basis for Jewishness, said study leader Harry Ostrer, M.D., professor of pathology, of genetics and of pediatrics at Einstein and director of genetic and genomic testing for the division of clinical pathology at Montefiore Medical Center. Dr. Ostrer noted that obtaining a comprehensive genetic fingerprint of various Jewish subpopulations can help reveal genetic links to heart disease, cancer, diabetes and other common diseases.

In a previous genetic analysis, the researchers showed that modern-day Sephardic (Greek and Turkish), Ashkenazi (Eastern European) and Mizrahi (Iranian, Iraqi and Syrian) Jews that originated in Europe and the Middle East are more related to each other than to their contemporary non-Jewish neighbors, with each group forming its own cluster within the larger Jewish population. Further, each group demonstrated Middle-Eastern ancestry and varying degrees of mixing with surrounding populations. Two of the major Jewish populationsMiddle Eastern and European Jewswere found to have diverged from each other approximately 2,500 years ago.

The current study extends that analysis to North African Jewsthe second largest Jewish Diaspora group. Their relatedness to each other, to other Jewish Diaspora groups, and to their non-Jewish North African neighbors had not been well defined. The study also included members of Jewish communities in Ethiopia, Yemen and Georgia. In all, the researchers analyzed the genetic make-up of 509 Jews from 15 populations along with genetic data on 114 individuals from seven North African non-Jewish populations.

North African Jews exhibited a high degree of endogamy, or marriage within their own religious and cultural group in accordance with custom. Two major subgroups within this overall population were identified: Moroccan/Algerian Jews and Djerban (Tunisian)/Libyan Jews. The two subgroups varied in their degree of European mixture, with Moroccan/Algerian Jews tending to be more related to Europeansmost likely stemming from the expulsion of Sephardic Jews from Spain during the Inquisition, starting in 1492. Ethiopian and Yemenite Jewish populations also formed distinctive genetically linked clusters, as did Georgian Jews .

Dr. Ostrers paper is titled, North African Jewish and non-Jewish populations form distinctive, orthogonal clusters. Additional Einstein contributors include: Christopher Campbell, Gil Atzmon, Ph.D., Carole Oddoux, Ph.D., Alexander Pearlman, Ph.D., and Edward R. Burns, M.D. Other contributors include: Pier Francesco Palamara and Itsik Pe'er, Ph.D. (Columbia University, New York, NY); Laura Rodrguez-Botigu and David Comas Martnez (Universitat Pompeu Fabra, Barcelona, Spain); Marc Fellous, M.D., Ph.D. (Cochin Institute, Inserm, Paris, France); Li Hao, Ph.D. (University of Medicine and Dentistry of New Jersey, Newark, NJ); Brenna Henn, Ph.D., and Carlos Bustamante (Stanford School of Medicine, Stanford, CA); Maya Dubrovsky and Eitan Friedman, M.D., Ph.D (Tel-Aviv University, Tel Aviv, Israel).

The research was supported by grants from the Lewis and Rachel Rudin Foundation; the Iranian-American Jewish Federation of New York; the U.S.-Israel Binational Science Foundation; National Cancer Institute (CA121852) of the National Institutes of Health; and Ruth and Sidney Lapidus.

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About Albert Einstein College of Medicine of Yeshiva University

Albert Einstein College of Medicine of Yeshiva University is one of the nations premier centers for research, medical education and clinical investigation. During the 2011-2012 academic year, Einstein is home to 724 M.D. students, 248 Ph.D. students, 117 students in the combined M.D./Ph.D. program, and 368 postdoctoral research fellows. The College of Medicine has 2,522 full time faculty members located on the main campus and at its clinical affiliates. In 2011, Einstein received nearly $170 million in awards from the NIH. This includes the funding of major research centers at Einstein in diabetes, cancer, liver disease, and AIDS. Other areas where the College of Medicine is concentrating its efforts include developmental brain research, neuroscience, cardiac disease, and initiatives to reduce and eliminate ethnic and racial health disparities. Its partnership with Montefiore Medical Center, the University Hospital and academic medical center for Einstein, advances clinical and translational research to accelerate the pace at which new discoveries become the treatments and therapies that benefit patients. Through its extensive affiliation network involving Montefiore, Jacobi Medical Center Einsteins founding hospital, and five other hospital systems in the Bronx, Manhattan, Long Island and Brooklyn, Einstein runs one of the largest post-graduate medical training programs in the United States, offering approximately 155 residency programs to more than 2,200 physicians in training. For more information, please visit http://www.einstein.yu.edu and follow us on Twitter @EinsteinMed.

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New Study Defines the Genetic Map of the Jewish Diasporas

North African Jews are more closely related to Jews from other parts of the world than they are to most of their non-Jewish neighbors in North Africa, a study has found.

Furthermore, their DNA carries a record of their migrations over the centuries: Some bits trace back to the Middle Eastern peoples thought to have migrated to North Africa more than 2,000 years ago, while other bits are linked to Spanish and Portuguese Jews who fled to North Africa after their expulsion from the Iberian Peninsula in the late 15th century, the study's authors said.

The discovery falls in line with other research showing that Jewish people from Europe and the Middle East share more DNA with one another than they do with outside groups, said Dr. Harry Ostrer, a medical geneticist at the Albert Einstein College of Medicine in New York and lead author of the report, published Monday in the Proceedings of the National Academy of Sciences.

"Jews tend to be more related to one another than they are to non-Jews, including non-Jews living nearby it's true in every region," he said.

Ostrer's earlier work had mainly focused on DNA samples collected from American Jews. Hoping to "catch up" and present a more complete picture of Jewish history and diversity, he and his colleagues analyzed DNA samples from 145 people of North African Jewish origin from Morocco, Algeria, Tunisia, Djerba (an island off the Tunisian coast) and Libya.

Comparing the collected DNA with genetic data from a variety of other Jewish and non-Jewish groups, they found that the North African populations clearly had genetic patterns more similar to European and Middle Eastern Jews than non-Jewish people currently living in the region. The data indicate that, once established in their communities, Jews in this region did not often intermarry with non-Jewish neighbors.

The scientists also saw that North African Jews formed two major subgroups: Moroccan and Algerian Jews shared more DNA with European Jews than was seen for Tunisian, Djerban and Libyan Jews.

This is probably because Jews living in Western Africa intermarried with Sephardic Jews who fled there after their expulsion from Spain and Portugal in the late 15th century, the researchers wrote.

Yeshiva University historian Lawrence Schiffman said the results lined up nicely with the historical record.

"It's exciting to see that what we know from the history books is turning out to be real in the genetics," he said.

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Genetics study of North African Jews tells migratory tale

A Waikato farmer is demanding compensation after a genetic mutation in a commercial breeding bull created unusually hairy calves that are getting into water troughs to cool off.

The organisation that provided the bull semen, Hamilton-based dairy genetics company Livestock Improvement (LIC), said it would not pay compensation as the genetic mutation is ''naturally occurring'', meaning it did not result from anything LIC did.

If it was liable and did pay compensation, LIC says it could be exposed for nearly $2 million.

South Waikato farmer Craig Littin is one of about 900 affected farmers nationwide, including about 400 farmers in the Waikato. About 1500 calves, all heifers, are understood to be affected, as carriers of the genetic mutation.

Littin said he had 10 defective calves bred from semen bought from LIC.

The defective semen is from a holstein-friesian bull called Matrix, by a holstein-friesian sire called Halcyon.

"The Matrix calves have come out really funny. They are extremely hairy and are doing really strange things, like sitting in water troughs to try and control their body temperature," Littin said.

The Lichfield dairy farmer, who runs a cross-bred herd, said LIC should pay him full compensation for the defective animals.

LIC confirmed there was a genetic mutation in Matrix, inherited from its sire, which has affected about half the female calves bred from the Matrix semen.

LIC also confirmed the traits from the mutation, which include excessive hairiness and a lack of heat tolerance. It has received about 40 complaints from farmers.

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Genetics company refuses to cover defective calves

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

Interleukin Genetics, Inc. (ILIU) announced today that it will host a conference call and Webcast on Tuesday, August 14, 2012 at 4:30 p.m. ET to discuss the Companys second quarter results.

To access the live call, dial 877-324-1976 (domestic) or 631-291-4550 (international). The live Webcast and replay access of the teleconference will be available on the Investors section of Interleukin Genetics, Inc.s Website at http://www.ilgenetics.com.

About Interleukin Genetics

Interleukin Genetics, Inc. (ILIU) develops and markets a line of genetic tests under the Inherent Health and PST brands.The products empower individuals to prevent certain chronic conditions and manage their existing health and wellness through genetic-based insights with actionable guidance. Interleukin Genetics leverages its research, intellectual property and genetic panel development expertise in metabolism and inflammation to facilitate the emerging personalized healthcare market. The Company markets its tests through partnerships with health and wellness companies, healthcare professionals and other distribution channels. Interleukin Genetics flagship products include its proprietary PST genetic risk panel for periodontal disease and tooth loss susceptibility sold through dentists, and the Inherent Health Weight Management Genetic Test that identifies the most effective diet and exercise program for an individual based on genetics. Interleukin Genetics is headquartered in Waltham, Mass. and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). For more information, please visit http://www.ilgenetics.com.

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Interleukin Genetics, Inc. Announces Conference Call to Discuss Second Quarter 2012 Results

In an effort to get FDA approval for a new cancer therapy, pharmaceutical giant Novartis is teaming with the University of Pennsylvania and investing at least $20 million in a new center to expand the university's work.

The collaboration between Novartis and Penn is expected to start in the fall with a new research and development facility, the Center for Advanced Cellular Therapies, to be established within the next year. The center's location has not yet been determined but will most likely be on Penn's campus, university officials said Sunday.

The partnership comes after a Penn team led by immunologist and gene-therapy pioneer Carl June published work last year in two major journals showing that it had genetically engineered patients' T cells - the big guns of the immune system - to recognize and attack the malignant cells of chronic lymphocytic leukemia, and then stand guard against the disease.

Although only three patients who had failed standard therapies were treated with the designer T cells, all three went into lengthy remission. Never before in published experiments had engineered T cells multiplied - and then persisted - enough to be so effective in patients.

David Strayer, a professor of pathology at Thomas Jefferson University who has long studied gene therapy, said the Penn and Novartis agreement comes "at a time when research funding is quite difficult to garner."

The partnership is an "encouraging sign" that large pharmaceutical companies are willing to team with medical schools.

"This could be the tip of the iceberg in pharmaceutical companies' having an interest in products being designed and developed by medical schools," Strayer said.

For all their sophistication, the designer T cells - with what scientists call chimeric antigen receptors (CAR) - remain experimental. The new T cells kill both healthy and cancerous B cells, so patients' supply can be permanently depleted.

B cells, which help fight viral and bacterial infections, are not indispensable to the body. But patients who lack B cells need regular intravenous doses of immunoglobulins to reduce their chances of infection.

In an editorial in the New England Journal of Medicine, two oncologists, who called the results of the new study impressive, also warned that toxic effects, known and unknown, "could pose substantial problems."

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Penn and Novartis will team on cancer research

Public release date: 6-Aug-2012 [ | E-mail | Share ]

Contact: Professor Hannes Lohi hannes.lohi@helsinki.fi 358-919-125-085 University of Helsinki

The genetics research group led by Professor Hannes Lohi, based at the University of Helsinki and the Folkhlsan Research Center, has, in collaboration with Adjunct Professor Kirsi Sainio's research group, discovered the cause of a life-threatening skeletal disorder affecting Brazilian Terriers. The disease is caused by a mutation in the GUSB gene. Malfunction of the GUSB gene has previously been linked to a severe skeletal disorder in humans, called type VII mucopolysaccharidosis (MPS VII).

The gene discovery is yet another example of a shared disease heritage between dogs and humans. Based on this study a gene test has been developed for the breed to eliminate the disease.

The study has been published in PLoS ONE journal on July 5, 2012.

Bone abnormalities are common in a group of lysosomal storage diseases, also known as mucopolysaccharidosis (MPS). Lysosomes are microscopic intracellular organelles that consist of more than 40 different degradative enzymes. They function as a cellular "cleaning system" and are responsible for example digesting foreign bacteria in the cells and destroying damaged cellular components. Functional defects in the lysosomal enzymes lead to the accumulation of a particular structural component, glycoaminoglycan, in the lysosomes, and this in turn leads to the development of skeletal disorders known as mucopolysaccharidoses.

Eleven different MPS diseases have already been found in humans. Typical features of the disease include dwarfism, skeletal abnormalities, coarse facial features, cloudy corneas and overgrowth of the internal organs.

Dogs are known for extreme structural variation, and some of these features have been intentionally bred. For example, the length of the limbs varies greatly between breeds. Besides breed-specific particularities, dogs also have serious inherited skeletal disorders, the genetic backgrounds of which are now being discovered.

The diagnosis of the skeletal disorder in Brazilian Terriers confirmed by gene discovery

A few years ago our research group was introduced to Brazilian Terrier puppies that had severe congenital skeletal abnormalities in the limbs, loose joints, facial deformities and dwarfism. The affected puppies could not move and had to be put down before the second month of life.

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The genetic cause of a severe skeletal disease in Brazilian Terrier puppies revealed

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

Interleukin Genetics, Inc. (ILIU) announced today that the Company has received top line results from the Periodontal Disease Prevention Study (PDPS) being conducted by the University of Michigan School of Dentistry. The preliminary results indicate that in Low Risk patients, there was no significant difference between two dental preventive visits per year and one preventive visit per year in reducing the percentage of patients who had tooth extractions over the 16 year monitoring period; 13.8% versus 16.4% (p=0.092 ns). In addition, results indicate that in High Risk patients, two preventive visits per year significantly reduced the percentage of patients who had extractions over a 16 year monitoring period compared to one preventive visit per year; 16.9% vs. 22.1% (p=0.002). There was also a positive relationship between number of risk factors and the percentage of patients with extractions (p<0.001). The Low Risk population (approximately 47% of the study) was defined as non-smokers, genetically negative per the Companys PST test and no history of diabetes. High Risk patients were defined as having one or more risk factors, i.e. PST positive, diabetes or smoking.

For more than 50 years, adult patients have been advised to visit the dentist every six months for an examination and cleaning. However, the data from this study appears to question the every six months, one-size-fits-all model for preventive dental visits for adults in a low risk population, said Lewis H. Bender, Chief Executive Officer of Interleukin Genetics. These results support movement towards more personalized preventive measures for the management of periodontal disease in low risk individuals, while encouraging more preventive care in high risk patients.

The PDPS was led by William Giannobile, D.D.S., D.Med.Sc., Director of the Michigan Center for Oral Health Research and Chair of the Department of Periodontics and Oral Medicine at the University of Michigan School of Dentistry, and enrolled approximately 5,400 consenting adults. Patients were identified through a large dental claims database with more than 16 consecutive years of documented oral health history.Participants provided a DNA sample and information on other risk factors to allow them to be classified as either Low Risk or High Risk for periodontitis development. The PST Genetic Test identifies individuals with increased risk for severe and progressive periodontal disease and significant tooth loss based on a proprietary panel of genetic variations that predispose an individual to over-express inflammation. Investigators intend to seek to publish the study results as soon as possible.

Approximately 8 to 15 percent of adult Americans have moderate to severe periodontitis, which, if not diagnosed early and treated properly, can lead to tooth loss, and major changes in appearance. In addition, clinical studies have associated severe periodontal disease with increased risk for heart attacks, strokes and other systemic diseases. Multiple studies have shown that a small number of risk factors, including smoking, diabetes and genetics, are responsible for much of the differences among patients in the severity and progression of periodontal disease. This study was funded by Renaissance Health Service Corporation, a nonprofit organization focused on the advancement of oral health.

About Periodontal Disease and Oral Health Care

According to the American Academy of Periodontology, periodontitis (gum disease) is a chronic inflammatory disease initiated by bacterial accumulations on the teeth. If untreated, or inadequately treated, periodontitis destroys the bone and soft tissues that support the teeth and ultimately leads to tooth loss. Although bacteria are essential for initiating periodontitis, the severity of disease and response to treatment is the result of disease modifying factors including smoking, diabetes, and genetics. Multiple studies have shown that genetic factors are responsible for more than 50 percent of the differences among patients in the severity of periodontal disease.Recent studies link periodontitis with diabetes, heart disease, stroke, premature births, and low-weight births. According to information from the Center for Disease Control and Prevention, one-fourth of U.S. adults aged 60 and older have lost all of their teeth.In 2009, an estimated $102 billion was spent on dental services in the United States, and each year Americans make about 500 million visits to dentists. More information is available through the American Academy of Periodontology at http://www.perio.org.

About Interleukin Genetics, Inc.

Interleukin Genetics, Inc. (ILIU) develops and markets a line of genetic tests under the Inherent Health and PST brands.The products empower individuals to prevent certain chronic conditions and manage their existing health and wellness through genetic-based insights with actionable guidance. Interleukin Genetics leverages its research, intellectual property and genetic panel development expertise in metabolism and inflammation to facilitate the emerging personalized healthcare market. The Company markets its tests through partnerships with health and wellness companies, healthcare professionals and other distribution channels. Interleukin Genetics flagship products include its proprietary PST genetic risk panel for periodontal disease and tooth loss susceptibility sold through dentists and the Inherent Health Weight Management Genetic Test that identifies the most effective diet and exercise program for an individual based on genetics. Interleukin Genetics is headquartered in Waltham, Mass. and operates an on-site, state-of-the-art DNA testing laboratory certified under the Clinical Laboratory Improvement Amendments (CLIA). For more information, please visit http://www.ilgenetics.com.

Certain statements contained herein are forward-looking statements, including statements that the clinical studies have the potential to expand the use of the PSTGenetic Test.Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those risks and uncertainties described in the Interleukin Genetics annual report on Form 10-K for the year ended December 31, 2011 and other filings with the Securities and Exchange Commission. Interleukin Genetics disclaims any obligation or intention to update these forward-looking statements.

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University of Michigan Informs Interleukin Genetics of Study Results Using the PST Genetic Test in Determining the ...

Public release date: 6-Aug-2012 [ | E-mail | Share ]

Contact: David Sampson jmdmedia@elsevier.com 215-239-3171 Elsevier Health Sciences

Philadelphia, PA, August 6, 2012 Individuals with mutations in BRCA1 and BRCA2 genes have a significantly higher risk of developing breast and ovarian cancers. Families at risk have been seeking genetic testing and counseling based on their mutation carrier status, but the standard method of direct sequencing is labor-intensive, costly, and it only targets a part of the BRCA1 and BRCA2 genes. A group of Canadian scientists has developed a new sequencing approach to provide a more effective method of BRCA1/2 mutational analysis. Their work is published in the September issue of The Journal of Molecular Diagnostics.

"A comprehensive understanding of BRCA1/2 genotypes and the associated tumor phenotypes is needed to establish targeted therapies," notes lead investigator Hilmi Ozcelik, PhD, of the Fred A. Litwin Centre for Cancer Genetics, Samuel Lunenfeld Research Institute, Mount Sinai Hospital, Toronto, Ontario, Canada. "Recent studies have suggested that certain chemical inhibitors are effective for the treatment of breast cancer in patients with BRCA1/2 mutations. Therefore, availability of new, affordable, and comprehensive technologies to screen for these mutations will be critical to identify patient-candidates for targeted therapies."

The investigators used a technique called long range PCR to generate amplified BRCA1/2 fragments, known as amplicons, from the DNA of 12 familial breast cancer patients. The amplicons were screened using deep sequencing, also known as Next Generation Sequencing (NGS), which allows for the simultaneous screening of millions of DNA molecules, thereby dramatically increasing speed and throughput. While conventional screening methods target only the exons of BRCA1/2, deep sequencing can screen the entire genomic region, including introns and untranslated regions. The specimens had been previously analyzed using conventional methods, allowing for a comparison of results.

In addition to identifying one genetic variant that was missed due to human error, the new method successfully identified all of the expected BRCA1/2 variants. They identified both exonic and exon/intron boundary variants. The test was done at a very low cost, and with a turnaround time of 12 days. "One of the key advantages of workflow of long-range PCR is the ability to visually detect large genomic duplications, deletions, and insertions," notes Dr. Ozcelik. "When combined with next generation sequencing, long range PCR can be a powerful tool in the detection of BRCA variants in the clinical setting. Our method confirmed the presence of variants with very high accuracy, and without false-positive results."

Long-range PCR and next generation sequencing identified a wide range of intronic BRCA1/2 variants, both commonly occurring and rare, that individually or in combination may impact BRCA1/2 function. Dr. Ozcelik notes that despite a small sample size, the data shows great variability in the number, type, and frequency of variants that can be identified from familial breast cancer patients.

"Our challenge now is to establish analytical methods that systematically investigate this more comprehensive data in order to provide better risk information for clinical management of the disease," says Dr. Ozcelik. "Given the extensive level of genetic information acquired from each patient, profiles can be constructed in breast cancer patients compared to population controls to produce a more effective means of generating BRCA1/2-associated risk to the individuals and their families.

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New method provides fast, accurate, low cost analysis of BRCA gene mutations in breast cancer

Brazil is using genetic engineering to help fight dengue fever, creating mosquitoes whose offspring die before they mature. Tests in two towns have been successful - but are there ecological implications?

Dengue is a tropical fever with similar symptoms to the flu: feverand shivering, headache and joint pain, and a rash. Most infections are comparatively mild and last no longerthan a week.

But every year there are around half a millionserious cases,some of which prove fatal.The disease hasspread considerably in recent years. Even Europe is no longer safe. In 2010, more than 600 travellers returning to Europe from abroadwere diagnosed with dengue fever. "The number of unreported cases is estimated to be farhigher," says Jonas Schmidt-Chanasit from the Bernhard Nocht Institute for Tropical Medicine in Hamburg."We believe it could be ten times as many."2010 alsosaw the very first cases of infection in France and Croatia.

The root of the problem

Aedes aegypti, the mosquito's scientific name,has a black and white patternand is actually quite pretty, as insects go. Butit can carry andtransmit several viruses. It's one of the maincarriers of yellow fever, and for humans it can be disastrous. In the Spanish-American War of 1898, the number of US soldiers who diedof this kind of infectious diseaseis believed to have beenhigher than the number killed in battle. There is nowa vaccine against yellow fever, but none has yet been foundto preventdengue fever.

Fertile breeding ground for mosquitoes: a teaspoonful of standing water is enough

All attempts to fight the mosquitoes with the help of insecticide have failed. In Brazil, awareness campaigns warn peoplenot leavecar tires lying around where rain can collect inside them, and toflush toiletsregularly, even if they're not beingused.Thedangerous larvae generally breed in standing water,which people are advised to avoid - but the mosquitoes can also breed ina puddle, a hollow in a rock, or eventheheart ofa flower.A teaspoon of water isallthey needin order to deposittheir eggs.

Assistance fromgenetic engineering

British scientistswith the company Oxitec have now developed a genetically-modified male mosquito whose offspringare unable to survive into adulthood. The idea is that the genetically-modifiedmalesarereleased intoa natural environmentandallowed tomate with female mosquitoes. The fertilized eggs developinto larvae or pupae, andthen die.

Oxitec hasconducted successfulfield trials on the Cayman Islands and in Malaysia. In 2011, the biotech company Moscamed in the Brazilian city of Juazeiro joined the project. Here, in the hinterland of Brazil's Bahia state, dengue is more common than almost anywhere else in the world.

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Genetically modified mosquitoes combat disease

AP

Raiders linebacker Aaron Curry isnt sure when hell be able to get back on the field, but hes pretty sure that stem cell therapy will be the thing that winds up getting him back there.

Paul Gutierrez of CSNBayArea.com reports that Curry has received the therapy on both of his knees. Bone marrow from his hips was used in the treatment and Curry told Gutierrez that it is the only thing hes tried that has helped him feel better. Curry is still working out on the side during Raiders practices and said hell only return to practice when hes fully able to help the Raiders.

My goal is to get healthy and just go out there and be violent, be fast, be a pain in the offenses butt and whatever I have to do on the defense, do it, Curry said. And do it full speed. I cant do that until my body says its ready.

The treatment has been popular with Oakland athletes. Linebacker Rolando McClain said that the treatment helped his legs feel better earlier this offseason and As pitcher Bartolo Colon has credited stem cell treatment on his shoulder with saving his baseball career.

With McClain facing a possible suspension under the Personal Conduct Policy and Oakland short on linebacking depth, the Raiders need Curry to be healthy for the start of the season.

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Aaron Curry using stem cell therapy to help knees

Hamish McMillan bee gene's tests won him the best of fair award at the Otago Science and Technology Fair. Photo by Craig Baxter.

It was his father David's work in honey production that prompted the study looking at the complementary sex determiner, or CSD, in bees.

Hamish (17), a year 13 pupil at John McGlashan College, said as varroa was moving throughout New Zealand, including Otago, he wondered what would be lost if the feral or wild populations of bees were wiped out.

Testing both feral and managed populations, he found the majority of genes to be individual to each type of bee.

"As varroa moves through, it will kill off the feral hives and we'll lose that diversity."

The effect would be lower hive population numbers as hives became more vulnerable to disease and varroa.

"It will weaken the hives and lower the honey production."

He was looking at medical research as a career and planned to attend the University of Otago next year.

A total of 285 exhibits from 25 schools in Dunedin and Otago were submitted to the fair.

-rebecca.fox@odt.co.nz

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Bee gene study top project

Aug. 5, 2012, 3 a.m.

A GROWING number of overseas clinics touting stem cell therapy for conditions ranging from sexual disorders to HIV are targeting Australia, where such treatments are restricted.

Australian scientists have raised concerns about so-called ''stem cell tourism'', saying many of the treatments offered are unproven, untested and potentially deadly.

The Swiss firm Fetal Cell Technologies International has been advertising in Australia since last year and Emcell, based in Ukraine, started promoting its services last month.

It is estimated as many as 200 Australians have travelled overseas for the therapy. The secretary for science policy at the Australian Academy of Science, Bob Williamson, said he empathised with the desperation of seriously ill people but warned against the unproven therapies, which can cost up to $60,000.

''The therapies are almost all untested and unproven and sometimes they have killed people,'' Professor Williamson said. The Sun-Herald's calls to Emcell's Melbourne office were not returned.

Stem Cells Australia's Megan Munsie, who is conducting a study into stem cell tourism with Monash University, said many people she interviewed were unaware of the risks of therapy overseas.

''We're not talking about rubbing something into your skin or taking a capsule, we are talking about often a very invasive procedure,'' she said.

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Fears over 'stem cell tourism' Save

A GROWING number of overseas clinics touting stem cell therapy for conditions ranging from sexual disorders to HIV are targeting Australia, where such treatments are restricted.

Australian scientists have raised concerns about so-called ''stem cell tourism'', saying many of the treatments offered are unproven, untested and potentially deadly.

The Swiss firm Fetal Cell Technologies International has been advertising in Australia since last year and Emcell, based in Ukraine, started promoting its services last month.

It is estimated as many as 200 Australians have travelled overseas for the therapy. The secretary for science policy at the Australian Academy of Science, Bob Williamson, said he empathised with the desperation of seriously ill people but warned against the unproven therapies, which can cost up to $60,000.

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''The therapies are almost all untested and unproven and sometimes they have killed people,'' Professor Williamson said. The Sun-Herald's calls to Emcell's Melbourne office were not returned.

Stem Cells Australia's Megan Munsie, who is conducting a study into stem cell tourism with Monash University, said many people she interviewed were unaware of the risks of therapy overseas.

''We're not talking about rubbing something into your skin or taking a capsule, we are talking about often a very invasive procedure,'' she said.

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Fears over 'stem cell tourism'

03-08-2012 07:00 CLICK HERE TO WATCH THE LATEST UPDATED VIDEO THAT CAME OUT TODAY Subscribe To Get Notified Of The Latest Releases As They Come Out Date: 08-02-12 Host: George Noory Guests: Elaine Fox, Sam Kean In the first half, experimental psychologist and neuroscientist, Elaine Fox, spoke about her work finding the roots of optimism and pessimism, and how we can retrain our brains to be more optimistic. In spite of the economic downturn, she reported that internationally, the vast majority of people are optimistic about the future, and tend to underestimate the chances of bad things happening to them. She characterized optimism in broader terms than just positive thinking, and suggested it has several components including taking positive actions, persistence, and having a sense of control. Surrounding yourself with negative or positive influences or people can make your brain pathways become more entrenched in those outlooks, she noted. Studies involving the so-called "optimism gene" found that those with this genetic marker were less inclined to fall into a depression when a number of negative events befell them, as compared to those without the genetic variant, who had an equal number of bad events occur. Though ultimately we need a balance of what she calls the "rainy" and "sunny" brain, to become more optimistic, she suggested challenging one's irrational negative beliefs, and practicing mindfulness-based meditation. She also pointed out that those ...

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Coast To Coast AM - Personality

As a medical student at Johns Hopkins University, Jimmy Lin worked on a case involving a 5-year-old whose development was suddenly stunted and who experienced unexplained and uncontrollable bouts of pain. His parents brought him to the best doctors at Harvard University, the Mayo Clinic and other top medical centers.

"It broke my heart seeing the parents' faces drop when we told them it was most likely a rare genetic condition," Lin said, sitting in a St. Louis coffee shop near the Washington University School of Medicine, where he now works as a genomics researcher. "I remember them walking down the hallway and wondering where they would go next."

Mainstream medicine hasn't focused its resources on the 7,000 rare diseases that have baffled doctors for decades and afflict a combined 350 million people worldwide.

"There are millions of kids wandering from place to place that no one is really helping," said Lin.

He believes answers may lie in their genes. To find out, he and more than a dozen other young scientists and researchers created the Rare Genomics Institute, a nonprofit that leverages falling DNA sequencing costs and rising online giving to support medical research. On the institute's website, children with mysterious illnesses can solicit the $7,500 needed to sequence their genes and their parents' in search of new therapies.

In mid-July, the institute announced that it had completed its first crowdfunded gene sequencing and discovered what it believes is the root cause afflicting 4-year-old Bronx resident Maya Nieder. The girl can't speak, and doctors are unsure whether she can hear. They had likewise failed to determine why she has missed so many developmental milestones.

Lin's team posted Nieder's story online, and within hours donors had given the $3,500 needed to sequence key slices of the Nieder family's DNA. (Yale University covered the rest of the costs.) The results, institute officials said, point to a flaw in a gene crucial to fetal development.

The institute carefully chooses the patients it spotlights online. Twenty of the roughly 100 applicants from the past year have been accepted. To appear on the Rare Genomics Institute's website, they must prove they have endured a battery of traditional tests and consulted with a range of doctors to no avail.

Joaking, the young son of a Chilean miner, is among those currently up on the site. His ability to move rapidly deteriorated in the past year.

"Joaking was a normal child until age 3, playing, jumping, climbing ladders, running," his father's testimonial recounts. "At age 4 my son cannot even scratch my face anymore." Family-organized bingo contests raised more than $2,000 to help fund Joaking's tests.

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Crowdfunding pays for genetic research

A GENE that can beat prostate cancer has been found by British scientists.

The gene, called Decorin, is carried by all men from birth and guards against tumours in the prostate gland.

But when it is faulty, carriers are in greater danger of developing the disease.

The discovery could help the development of drugs to stave off the disease or stop it spreading.

It could also lead to more accurate tests for the illness.

Dr Axel Thomson of the Medical Research Council, which carried out the research with Prostate Cancer UK, said: Decorins normal role may be to slow cancer growth, which is a really exciting possibility.

This could mean that, in the future, measurement of Decorin levels could become a reliable diagnostic test for prostate cancer and also help determine how aggressive the disease is.

Prostate is Britains most common form of cancer, but there is no definitive test for it. There are 250,000 men living with the disease, which kills 10,000 each year.

Dr Kate Holmes, of Prostate Cancer UK, added: This type of early stage research is vital to help us improve our understanding of prostate cancer development and move towards finding better ways to diagnose and treat the disease.

e.little@the-sun.co.uk

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Gene kills cancer of prostate

Scientists have identified a gene which could be instrumental in the growth of prostate tumours.

The discovery could lead to improved cancer diagnosis and treatment, according to researchers from the University of Edinburgh.

They looked at genes which control how the prostate gland is formed and found that one gene, called decorin, may have a key role in tumour growth.

Lead researcher Dr Axel Thomson, from the university's Medical Research Centre for Reproductive Health, said: "We pinpointed which genes were active in embryonic prostate development and compared their behaviour in the development of prostate cancer."

He continued: "Through this process we were excited to discover that the presence of one gene, decorin, was reduced in tumours compared to normal prostate cells.

"This observation suggests that decorin's normal role may be to slow cancer growth, which is a really exciting possibility.

"If our suspicions are verified then this could mean that, in the future, measurement of decorin levels could become a reliable diagnostic test for prostate cancer and also help determine how aggressive the disease is."

Dr Kate Holmes, head of research at charity Prostate Cancer UK which helped fund the research, said: "This type of early-stage research is vital to help us improve our understanding of prostate cancer development and move towards finding better ways to diagnose and treat the disease.

"Every year 10,000 men lose their lives to the disease, yet we still have very little knowledge of how prostate tumours develop and grow. It is vital that more research of this nature is undertaken and supported so that more clues, such as these, can be discovered."

The research is published in scientific journal Plos One.

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UK & World News: Gene 'could slow cancer growth'

Scientists have identified a gene that could be instrumental in the growth of prostate tumours.

The discovery could lead to improved cancer diagnosis and treatment, according to researchers from the University of Edinburgh.

They looked at genes which control how the prostate gland is formed and found that one gene, called decorin, may have a key role in tumour growth.

Lead researcher Dr Axel Thomson, from the university's Medical Research Centre for Reproductive Health, said: "We pinpointed which genes were active in embryonic prostate development and compared their behaviour in the development of prostate cancer.

"Through this process we were excited to discover that the presence of one gene, decorin, was reduced in tumours compared to normal prostate cells.

"This observation suggests that decorin's normal role may be to slow cancer growth, which is a really exciting possibility.

"If our suspicions are verified then this could mean that, in the future, measurement of decorin levels could become a reliable diagnostic test for prostate cancer and also help determine how aggressive the disease is."

Dr Kate Holmes, head of research at charity Prostate Cancer UK which helped fund the research, said: "This type of early-stage research is vital to help us improve our understanding of prostate cancer development and move towards finding better ways to diagnose and treat the disease.

"Every year 10,000 men lose their lives to the disease, yet we still have very little knowledge of how prostate tumours develop and grow. It is vital that more research of this nature is undertaken and supported so that more clues, such as these, can be discovered."

The research is published in the scientific journal, PLoS ONE.

Here is the original post:
Gene 'may slow cancer growth'

3 August 2012 Last updated at 20:13 ET

Scientists from Edinburgh University have pinpointed a gene they say could lead to improvements in the diagnosis and treatment of prostate cancer.

The team studied genes that control the formation of the prostate gland and identified one known as Decorin.

The presence of this gene was reduced in tumours compared to normal prostate cells.

The researchers now hope measurement of Decorin levels could become a reliable diagnostic test for prostate cancer.

The study by scientists from the Centre for Reproductive Health was funded by Prostate Cancer UK and the Medical Research Council (MRC).

They believe the gene, Decorin, may play an important role in tumour growth.

Lead researcher, Dr Axel Thomson, said: "We pinpointed which genes were active in embryonic prostate development and compared their behaviour in the development of prostate cancer.

"Through this process we were excited to discover that the presence of one gene - Decorin - was reduced in tumours compared to normal prostate cells.

"This observation suggests that Decorin's normal role may be to slow cancer growth, which is a really exciting possibility.

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Prostate 'growth' gene identified

August 3, 2012

April Flowers for redOrbit.com Your Universe Online

For about a dozen years, synthetic biologists have been working on designing genetic circuits to perform novel functions such as manufacturing new drugs, producing fuel or even programming the suicide of cancer cells.

Many factors have to be controlled for this dream to become a reality. Scientists have to gain control over complex genetic and cellular components, including genes and the regulatory proteins, called transcription factors, that turn them on and off.

So far, most researchers use bacterium transcription factors to design their synthetic circuits. These dont always translate well to nonbacterial cells and can be a challenge to scale. This makes it harder to create complex circuits.

Timothy Lu, assistant professor of Electrical Engineering and Computer Science at MIT, and a group of colleagues from Boston University and Massachusetts General Hospital have come up with a new method to design transcription factors for nonbacterial cells (in this case, yeast cells). To overcome the current bottleneck that has limited synthetic biology so far, they have designed an initial library of 19 new transcription factors.

Published in the August 2 issue of the journal Cell, the project is touted as being part of a larger, ongoing effort to create genetic parts that can then be assembled into circuits to achieve specific functions.

If you look at a parts registry, a lot of these parts come from a hodgepodge of different organisms. You put them together into your organism of choice and hope that it works, says Lu.

The team got a much-needed boost to build this new library of parts from recent advances in designer proteins that bind DNA.

Transcription factors have a section that latches onto specific DNA sequences, called a promoter. The protein then uses an enzyme called RNA polymerase to start copying the gene into messenger RNA, the molecule that carries genetic instructions to the rest of the cell.

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Library Of Genetic Circuits Developed For Scientific Functions

The FDA is unlikely to rule out personal genetics tests, but it may require that physicians get more involved.

Self awareness: 23andMe ships "spit kits" directly to consumers who want to explore their genetic makeup. flickr creative commons | Pelle Sten

Personal genetics company 23andMe announced it has applied for U.S. Food and Drug Administration approval for seven of its genetic tests. The company hopes that FDA approval will increase consumer confidence and interest in its tests, and ultimately feed into its goal of crowdsourcing human genetic information for medical research.

But it could be a risky moveif regulatory approval includes a requirement for a medical provider's involvement, that could interfere with the company's direct-to-consumer model, at least for some of its tests.

"That's the part where we are going to have to see how it plays out," says Linda Avey, a cofounder of 23andMe who has since left the company. The direct-to-consumer model was a founding principle of 23andMe, which emphasizes individual participation in health and medicine, says Avey.

23andMe, in which Google has invested $6.5 million, offers a genome analysis test directly to consumers, who can use the product to explore their genetic risk for everything from curly hair to Alzheimer's disease. Although the company isn't disclosing which particular tests it is seeking regulatory approval for, Ashley Gould, vice president for corporate development and chief legal officer, says the tests are medically relevant and examine genetic variants with disease connections that are well supported by scientific research. The company is already working on a second submission, and plans to eventually seek approval for some 100 of its 240 tests.

The company has made two other significant moves within the medical arena in recent months. In May, the company patented a genetic variant for Parkinson's disease risk. Last month, 23andMe acquired a patient networking site called Cure Together, an online forum where users share stories of their personal experiences with disease and treatment (see "23andMe Expands Its Data-Mining Operations").

For $299, you can order a genetic test for every genetic trait the Silicon Valley-based company examines. Consumers receive a kit in the mail and return a saliva sample that is then analyzed for around a million variants in the genome. Some of the variants connect to harmless traits like eye color. Others have serious medical implications, such as risk for Parkinson's disease and how an individual's body will respond to certain drugs.

This isn't the first time 23andMe has dealt with the FDA. In 2010, the FDA sent letters of warning to 23andMe and four other direct-to-consumer genetics companies, warning them that their genetic testing service is a medical device and thus needs regulatory approval. The FDA says it oversees direct-to-consumer genetic tests to ensure that such products are safe and effective, and to make sure that manufacturers deliver on their medical claims. "The goal is to ensure that consumers have access to accurate and reliable information that consumers can use to help better understand their own health needs and how to go about seeking additional information," said an agency spokesperson by e-mail.

23andMe's move to seek regulatory approval is a first for the direct-to-consumer genetics market, and is widely viewed as a necessary step forward. "I think it's a positive move in general for the industry and the field," says Cinnamon Bloss, a clinical psychologist at the Scripps Translational Science Institute who studies how people respond to the kind of genomic information supplied by 23andMe and others. "A central issue is going to be how [the FDA] responds to the notion of offering these tests directly to the consumer," she says.

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Personal Genetics Company Seeks Regulatory Approval