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| Ex Vivo Metrics™: How Drug Studies in Reanimated Human Organs Could Revitalize the Drug Development Process
An editorial by Gerald Curtis, PhD
Fallout from the catastrophic phase I clinical trial of TeGenero’s monoclonal antibody TGN1412 in March 2006,1 in which 6 volunteers suffered life-threatening “cytokine storms,” includes newly tightened regulations in the United Kingdom and renewed concern worldwide about first-in-human trials, particularly for compounds with novel targets or mechanisms of action.
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Editorials
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| DNA
Genotyping from human FFPE Samples |
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In this feasibility study, Applied Biosystems demonstrates how the combined
use Recover All Total Nucleic |

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Acid Isolation Kit and TaqMan SNP Genotyping
Assay can result in high quality, reproducible, and reliable genotyping
data.. Read
more |
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Millipore has
launched the CellCiphr Cytotoxicity Profiling Assay Kit
using human HepG2 cells. This assay panel detects
drug-induced hepatotoxicity and is expected to be used
early in the drug discovery process. read
more
Cartesian Gridspeed, Ltd. announced the
opening of its new sales, marketing and technical support
subsidiary, SLIM Search, Inc. in Mission Viejo,
California. SLIM
Search, Inc. is marketing
its SLIM Search genomic search tool to universities,
government research, and research and development
departments of biotechnology corporations and individual
contributors. read
more
The new Variant Reporter Software from Applied
Biosystems automates detection of variants and
streamlines data analysis process. The software uses
proprietary algorithms to identify genetic variations
based on standardized or user-defined parameters. Results
are presented for validation in a visual format that
allows researchers to simultaneously compare multiple
quality control metrics. More information and a free trial
version are available at:
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Products
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| We invite your comments and feedback for this edition of Biomarker Breakthroughs. Email us at
maloryea@gmail.com |
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Lund University Scientists Pioneer microRNA Profiling in Immune Disease
By Malorye Allison
MicroRNAs (miRNAs) have already begun to revolutionize our understanding of oncology. Now these tiny single strands of mRNA are being studied in immune disease as well. “So far, we have identified only few genes clearly associated to polygenic immune disorders, such as asthma or diabetes,” explains Corrado Cilio, an associate professor at Lund University in Malmoe, Sweden. “It is therefore conceivable that miRNAs are involved in the fine tuning of genes controlling the molecular pathways leading to these diseases.”
A handful of provocative studies have piqued interest in this area. “Some data from mouse work suggest that miRNA might be important in regulating the immune system,” Cilio says. For example, knockout mice whose T cell lineage cannot produce the Dicer enzyme, which is required for maturation of miRNA, also have clear defects in immune regulation. (See
Cobb et
al.)
Very little research has been done on miRNA in immune diseases in humans, however. Partly, that’s because studying microRNAs can be tedious work. “That’s why I jumped on this assay,” says Cilio, speaking of Luminex’s FlexmiR Human Panel. The FlexmiR products use Exiqon A/S’s Locked Nucleic Acids (LNA) probe technology and Luminex xMAP microspheres to measure miRNA directly from patient samples in microtiter plates. The miRNA expression level is read using a Luminex analyzer.
Using the assay, Cilio says his lab gets results “fast.” In addition, “With this assay [FlexmiR] we did not have to amplify the miRNA, so you measure exactly what you have,” he says. The assay is also convenient. “We already use the Luminex analyzer for other things already, such as measuring cytokines in samples from mice and human serum,” Cilio explains.
The main drawback to the FlexmiR assay now is cost, according to Cilio. “As a small academic lab, we can’t afford to do a lot of samples using this system,” he says. So, just as researchers originally used gene chips to do screening studies of gene expression levels, they are using the FlexmiR Human panel to do their “fishing” and first examine a few samples for many miRNAs. Once they’ve identified some good targets, they’ll use real-time PCR in the large-scale studies. Over time, Cilio says, “The price of these kinds of assay will probably drop, just like it did with the gene chips.”
Cilio is hopeful that just as miRNAs have opened up a whole new view of cancer, studies like his will finally illuminate the challenging and complex world of immunology.
Additional Reference:
Cuellar, TL, and McManus, MT, “MicroRNAs and Endocrine
Biology,” Journal of Endocrinology (2005) 187, 327-332.
4-04- 07 - Biomarker Breakthroughs
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