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University of Alberta, Third Wave Technologies, FDA, Motif, Imperial College London, Gene Express, Personalized Medicine Coalition, Abbott, Genentech, Roche, OSI Pharmaceuticals, National Institute of Mental Health

Univ. of Alberta Researchers Develop New ‘Lab-on-a-Chip’ Technology
A new, shoebox-sized unit for genetic testing has been developed by scientists at the University of Alberta in Edmonton, Canada, according to a report in the latest issue of Personalized Medicine.
The portable unit uses a reusable microchip-based system that costs approximately $1,000 to build. Researchers said the device has the same capability a fully equipped laboratory, can be used for point-of-care medical testing, and has the potential to lower the cost of genetic testing for consumers.
This lab-on-a-chip technology was developed by a team of researchers at the Department of Electrical and Computer Engineering at the University of Alberta lead by Christopher Backhouse. Researchers say that the system can yield results as fast as one hour.
Kaigala et al. have written a paper in The Analyst about the system in a paper titled “An inexpensive and portable microchip-based platform for integrated RT-PCR and capillary electrophoresis.” The authors propose many possible uses for such a portable genetic testing unit, including gauging populations that are likely to see adverse reactions to drugs, picking the right drug for the right patient, and for determining dosing schedules for therapies.
The researchers are applying their product broadly, from managing public health concerns to cancer treatment. They are working with Canadian industry partners DALSA, Micralyne, and iLOC.

Third Wave to Submit HPV Study Results to FDA in April; Shares Jump
Third Wave Technologies said this week that it will submit data from clinical trials on its human papillomavirus molecular diagnostic tests with the US Food and Drug Administration next month.
The Madison, Wis.-based firm said that its 14-type high-risk HPV test demonstrated a negative predictive value greater than 99 percent, which was the study’s goal. It said that it would provide further data from the study after its FDA submission.
The high-risk HPV test is intended to be used in combination with a Pap test to evaluate women aged 30 and over for the presence of high-risk HPV types and to guide treatment, said Third Wave.
Third Wave also intends to submit study data for its 16/18 HPV genotyping test, which it said achieved primary clinical endpoints, with the FDA next month. HPV types 16 and 18 have been implicated in 70 percent of cervical disease, according to Third Wave.
Third Wave said the global HPV testing market is projected to be $250 million in 2008. But the firm and Qiagen, which sells the only FDA-cleared molecular test for HPV, believe the market is highly under penetrated and could be valued at around $1 billion.

Motif Collaborating with Imperial College London on Diabetes, Obesity Genetics Research
The specialized genetics company Motif BioSciences is forming a new partnership with the Imperial College London aimed at deciphering the genetics of diabetes, obesity, and other related metabolic and cardiovascular disorders, the company announced this week.

Motif, which is an Amphion Innovations partner company, plans to team up with Imperial College’s head of genomic medicine Philippe Froguel, who has extensive experience studying metabolic diseases. Once they receive appropriate permission, Motif plans to access genetic samples and clinical data that Froguel and his collaborators have collected in Morocco.

Using their genomic analysis tools and high density microarray technology, Motif hopes to identify genomic variants that predispose some individuals to diabetes, obesity, and other diseases. This, in turn, may reveal new drug targets and molecular biomarkers, they said.

“This is Motif’s first major project in this field and we are excited to be working with such a highly respected, ground-breaking team,” Motif CEO Zaki Hosny said in a statement.


Gene Express Joins Personalized Medicine Coalition
Gene Express said this week that it has become a member of the Personalized Medicine Coalition, a group that aims to promote policies that will benefit medicine aimed at diagnosing and treating disease and illness based on an individual’s unique genetic requirements.
The non-profit group includes members from industry, academic medical centers, non-profit research entities, patient advocacy groups, and others.
David Lester, senior vice president of strategy and corporate development of Toledo, Ohio-based Gene Express, also was selected join the PMC’s public policy committee.

Abbott to Develop Molecular Test for Tarceva in Collaboration with Genentech, Roche, and OSI
Illinois-based diagnostics company Abbott has entered into an agreement with Genentech, Roche, and OSI Pharmaceuticals to create a genetic test for determining which lung cancer patients will benefit from erlotinib treatment, the company announced last week.
Erlotinib, which goes by the trade name Tarceva, is an oral tablet used to treat locally advanced or metastatic non-small cell lung cancer in patients who have tried chemotherapy unsuccessfully. It targets a cell-surface protein called the epidermal growth factor receptor that is often overexpressed in non-small cell lung cancer.
Abbott intends to apply its fluorescence in situ hybridization technology to develop a test for extra copies of the gene coding for EGFR. To date, the US Food and Drug Administration has not approved any nucleic acid based tests for predicting successful lung cancer treatment, said Abbott.
Financial terms of the agreement were not disclosed.

NIMH Offering $5M for Genomic Approaches to Bipolar Disorder, Schizophrenia
The National Institute of Mental Health will fund seven or eight grants with a total of around $5 million to use genomic approaches to study schizophrenia and bipolar disorder, the National Institutes of Health has announced.
The funding, which will go to both R01 and R01 collaborative awards, is aimed at expanding existing resources for schizophrenia and bipolar disorder research under the NIMH’s Human Genetics Initiative. Researchers will use the funds to apply genomic and related tools to advance the knowledge of the molecular origins of these diseases.
Areas of investigation under these grants may include, but are not limited to: combining data sets generated under this initiative with existing ones to replicate previous findings or detect additional genes underlying these disorders; combining samples from different studies using different methods and studying innovative and cost-sparing ways for phenotypic and genomic analyses; conducting studies that allow for rapid and cost-effective ascertainment, recruitment, and clinical assessment of study subjects for large-scale genetic studies of schizophrenia or bipolar disorder; analyzing genes known to be related to development of mental disorders; and conducting high-density, whole-genome association analyses using existing technology platforms for SNP typing.
There are no specific budget or project term limits for the research, aside from the standard five-year budget limit. Letters of intent are due April 7 and applications are due May 6.
“Applications submitted in response to this initiative should focus on the rapid collection of large cohorts of clinically well-characterized populations of schizophrenia or bipolar subjects and controls (if appropriate) on a topic related to the genomic or genetic analysis of these traits, employing innovative analytical study designs,” the NIH said in its announcement. “The ultimate goal of successful applications will be to identify specific genomic and functional variants that influence susceptibility to schizophrenia and bipolar disorder.”

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The Scan

Transcriptomic, Epigenetic Study Appears to Explain Anti-Viral Effects of TB Vaccine

Researchers report in Science Advances on an interferon signature and long-term shifts in monocyte cell DNA methylation in Bacille Calmette-Guérin-vaccinated infant samples.

DNA Storage Method Taps Into Gene Editing Technology

With a dual-plasmid system informed by gene editing, researchers re-wrote DNA sequences in E. coli to store Charles Dickens prose over hundreds of generations, as they recount in Science Advances.

Researchers Model Microbiome Dynamics in Effort to Understand Chronic Human Conditions

Investigators demonstrate in PLOS Computational Biology a computational method for following microbiome dynamics in the absence of longitudinally collected samples.

New Study Highlights Role of Genetics in ADHD

Researchers report in Nature Genetics on differences in genetic architecture between ADHD affecting children versus ADHD that persists into adulthood or is diagnosed in adults.