Category Archives: Pharmacogenomics

NEW YORK, Feb. 16, 2012 /PRNewswire/ -- Reportlinker.com announces that a new market research report is available in its catalogue:

Future US Nucleic Acid Testing Market Outlook

http://www.reportlinker.com/p0773583/Future-US-Nucleic-Acid-Testing-Market-Outlook.html#utm_source=prnewswire&utm_medium=pr&utm_campaign=NoCategory

Highlights

Comprehensive 880-page market segmentation analysis of the US NAT market. Major issues pertaining to the US NAT laboratory practice, as well as key economic, regulatory, demographic, social and technological trends with significant market impact during the next ten years. An extensive review of DNA probe and biochip technologies, test formats, detection methodologies, trends in testing automation and amplification methods. Ten-year test volume and reagent sales forecasts for the following categories:

                 - Infectious Diseases

                 - Cancer

                 - Forensic Testing

                 - Genetic Diseases

                 - Paternity Testing/HLA Typing

Review of testing methodologies and instrumentation technologies. Feature comparison of automated and semiautomated analyzers. Sales and market shares of leading suppliers. Over 60 specific opportunities for NAT instruments, test systems, IT and auxiliary products. Profiles of major suppliers, and emerging market entrants, including their sales, product portfolios, marketing tactics, technological know-how, new products in R&D, collaborative arrangements and business strategies. Alternative market penetration strategies. Potential market entry barriers and risks. Business planning issues and concerns.

Contains 880 pages and 37 tables

Table of ContentsIntroduction

Worldwide Market And Technology Overview

A. DNA Sequencing

1. Introduction

2. Sequencing Methods

3. Autoradiography

4. The Human Genome Project

5. Sequencing Automation

6. Image Scanners

7. Fluorescent Detection

8. Gene Profiling

9. Gene Expression

10. Polymorphism Screening

11. Protein Interaction Networks

B. DNA And RNA Probe Technology

1. Basic Principles

2. Probe Preparation

3. The DNA Probe Test

a. Sample Preparation

b. Hybridization

c. Separation

d. Detection/Measurement

4. Test Formats

a. Filter Hybridization

b. Southern Blot

c. Northern Blot

d. In Situ Hybridization

e. Others

5. Labeling Techniques

6. Amplification Methods

O Polymerase Chain Reaction

- Temperature Cyclers

- PCR Variations* Immuno-PCR* QC-PCR* DAP-PCRO Strand Displacement ActivationO TMAO Ligase Chain ReactionO Branched DNA- Hybridization Protection AssayO Nucleic-Acid Sequence-Based AmplificationO Self-Sustained Sequence ReplicaseO Others- Ampliprobe- CAR- CAS- CPT- Dendritic Polymer Technology- ISO-CR- LAT- Probe Networks- RAMP- Repair Chain Reaction- Rolling Circles- Sequence Independent Gene Amplification- Sequence Initiation Reaction- SISPA- Solid Phase AmplificationC. Detection Technologies1. Radioactive Methodsa. Overviewb. Major IsotopesO P-32O S-35O H-3O I-1252. Non-Isotopic Methodsa. Enzymatic Labelsb. Chemical LabelingO Indirect Chemical LabelingO Direct Chemical Labeling

c. Fluorescence

d. Chemiluminescence

e. Electrical Conductivity

D. Instrumentation Review

1. Abbott LCx

2. Beckman Coulter/Biomek FK

3. Becton Dickinson SDA

4. Bio-Rad GeneScope

5. Gen-Probe Tigris

6. Roche Cobas Amplicor

7. Tecan LS Series

E. Biochips: Genosensors, Microarrays, and

Labs-on-the-Chip

- Liquid Transportation and Mixing

- Separation

- Reaction

- Detection

F. Pharmacogenomics

G. Major Applications

1. Microbiology/Infectious Diseases

a. Overview

b. Major Infectious Diseases

* AIDS

O Structure and Composition

O Classification

O AIDS Origins

O Animal Lentivirus Systems

O Virus Receptors

O HIV Infections in Humans

- Pathogenesis and Pathology

O CD4T Lymphocytes and Memory Cells

O Monocytes and Macrophages

O Lymphoid Organs

O Neural Cells

O Viral Coinfections

- Clinical Findings

O Plasma Viral Load

O Pediatric AIDS- Neurologic Disease- Opportunistic Infections- CancerO Immunity- Virus Isolation- Serology- Viral Nucleic Acid/Antigen DetectionO Epidemiology- Worldwide Spread of AIDS- United States- Routes of TransmissionO DNA Probes- Overview- Quantitative PCR- In Situ PCR- Needed ImprovementsO Viral Load/Drug Resistance TestingO Genotype and Phenotype TestingO Blood Banking Considerations* AdenovirusO BackgroundO Diagnostic TestsO Vaccines and DrugsO Adeno-Associated Viruses (AAV)* Anthrax/Bacillus AnthracisO BackgroundO Diagnostic TestsO Vaccines and Drugs* BabesiosisO Background* BEA and Other Bartonella DiseasesO BackgroundO Diagnostic TestsO Vaccines and Drugs* Chagas DiseaseO Background

* Campylobacter

O Background

O Diagnostic Tests

- Culture Identification

O Vaccines and Drugs

* Chlamydia

O Background

- Chlamydia psittaci

- Chlmaydia pneumoniae

- Chlamydia trachomatis

O Diagnostic Tests

O Vaccines and Drugs

* Creutzfeldt-Jakob's Disease

O Background

O Blood Transmission

O Diagnostic Tests

O Major Commercial and Academic Players

- Bayer

- Disease Sciences/Bio Tec Global

- Imperial College School of Medicine

- Ortho-Clinical Diagnostics

- Pall

- ProMetic Life Sciences

- Proteome Sciences/Idexx

- Q-One Biotech

- Serono

- U.S. Agricultural Research Service

O Drugs

O Vaccines

* Cytomegalovirus

O Background

- Chorioretinitis

- Gastrointestinal

- Central Nervous System Disease

O Diagnostic Tests

O Vaccines and Drugs

* Ebola Virus

O Background

- Epidemiology

- Clinical Syndromes

O Diagnostic TestsO Vaccines and Drugs* EchoVirusO Background- Acute Aseptic Meningitisis- Encephalitis- Exanthems- Respiratory Disease- Myopericarditis- Neonatal InfectionsO Diagnostic TestsO Vaccines and Drugs* EncephalitisO BackgroundO Diagnostic TestsO Vaccines and Drugs* EnterovirusesO BackgroundO Diagnostic Tests- Viral Isolation and Identification- Antibody TestsO Vaccines and Drugs* Epstein-Barr VirusO BackgroundO Diagnostic TestsO Vaccines and Drugs* GonorrheaO BackgroundO Diagnostic TestsO Vaccines and Drugs* HepatitisO Hepatitis AO Hepatitis B- Structure and Composition- ReplicationO Hepatitis CO Hepatitis D (Delta)O Hepatitis EO Hepatitis GO Hepatitis Infections PathologyO Clinical FindingsO Laboratory Tests

- Hepatitis A

- Hepatitis B

- Hepatitis C

- Hepatitis D

- Hepatitis E

O Virus-Host Immune Reactions

O Epidemiology

- Hepatitis A

- Hepatitis B

- Hepatitis C

- Hepatitis D (Delta)

O Vaccines and Drugs

* Herpes Simplex Virus

O Background

O Diagnostic Tests

O Vaccines and Drugs

* Legionella

O Background

O Diagnostic Tests

O Vaccines and Drugs

* Lyme Disease

O Background

- Clinical Description

- Clinical Case Definition

- Laboratory Criteria for Diagnosis

- Case Classification

O Diagnostic Tests

O Vaccines and Drugs

* Malaria

* Mycoplasma

O Background

- Ureaplasma Urealyticum & Mycoplasma

Hominis

O Diagnostic Tests

O Vaccines and Drugs

* Papillomaviruses/HPV

O Background

- HPV in Cancer

- Cervical Neoplasm

O Diagnostic Tests

O Vaccines and Drugs

- Prevention* Parvovirus B19O Background- Microbiology- Epidemiology- Clinical Syndromes- Erythema Infectiosum (Slapped Cheek)- Adult Polyarthropathy- Transient Aplastic Crisis- Transient Pancytopenia- Red Cell Aplasia in Immunocompromised- Perinatal InfectionsO Diagnostic TestO Vaccines and Drugs* PneumoniaO BackgroundO Diagnostic TestsO Vaccines and Drugs* PolyomavirusesO BackgroundO Diagnostic TestsO Vaccines and Drugs* SalmonellosisO BackgroundO Diagnostic TestsO Vaccines and Drugs* ShigellosisO BackgroundO Diagnostic TestsO Vaccines and Drugs* StreptococciO BackgroundO Diagnostic TestsO Vaccines and Drugs- Group A Streptococci- Group B Streptococci* ToxoplasmosisO BackgroundO Diagnostic TestsO Vaccines and Drugs

* Tuberculosis

O Background

O Diagnostic Tests

- Microscopic Characteristics

- Cultural Characteristics

- Skin Tests

- MDRTB

O Vaccines and Drugs

* West Nile Virus

O Background

- Clinical Syndromes

O Diagnostic Tests

O Vaccines and Drugs

* Yersinia

O Background

O Diagnostic Tests

O Vaccines and Drugs

c. Antibiotic Susceptibility

2. Cancer Testing

a. Overview

b. Major Cancer Types

* Prostate

* Lung

* Colon and Rectum

* Breast

* Skin

* Uterine

* Leukemia

* Oral

c. Oncogenes

O Abl/abl-bcr

O AIB1

O BCL-2

O BRCA1

O CD44

O C-fos

O C-myb

O C-myc

O CYP17

O Erb-B

O HPC1

O N-mycO P40O P51O P53O PIK3CAO PTI-1O RasO RegO SisO Src3. Genetic Diseasesa. Overviewb. Nucleic Acid Amplificationc. Chromosome Imagingd. Genomics Technologiese. Proteomics Technologiesf. Current Pharmacogenomic Testsg. Future Pharmacogenomic Testingh. Major Diseases* Achondroplasia* Autosomal Dominant Polycystic KidneyDisease* Cancer* Cosmetogenomics* Cystic Fibrosis* Down's Syndrome* Duchenne and Becker Muscular Dystrophy* Factor V (Leiden)* Factor IX Deficiency* Fragile X Syndrome* Heart Disease* Hemochomatosis* Hemophilia* Huntington's Disease* Maternal-Fetal Incompatibility* Multiple Endocrine Neoplasia* Phenylketonuria (PKU)* Polycystic Kidney Disease (PKD)* Prenatal Screening* Retinitis Pigmentosa* Retinoblastoma* Sickle Cell Anemia

* Spinal Muscular Atrophy

* Vitamin B12 Metabolism

i. Social Issues and Concerns

4. Forensic Testing

a. Overview

b. Multilocus and Single Locus Probes

* Multilocus Probes

* Single Locus Probes

* PCR and RFLP

c. The FBI

d. DNA Profile Data Banks

* U.S.A.

* U.K.

e. Judicial Implementation

f. Major Crime Categories

g. Factors Contributing to the DNA Probe

Market Expansion

* Technology Availability

* Use of Hair as Evidence

h. Wildlife Forensics

5. Paternity Testing/HLA Typing

6. Other Applications

a. Disease Susceptibility Testing

b. Cardiovascular Diseases

c. Diabetes

d. Alzheimer's Disease

e. Periodontal Disease

f. Plasma Purification

g. Organ Transplantation

h. Water Contamination

i. Other

H. Competing/complementing Technologies

1. Monoclonal Antibodies/Immunoassays

2. RNA Probes

3. Two-Dimensional Electrophoresis

4. Flow Cytometry

I. Worldwide Market Overview

1. Business Environment

2. Market Structure

3. Market Size and Growth

USAA. Executive SummaryB. Business EnvironmentC. Market StructureD. Market Size, Growth And Major Suppliers'Sales And Market SharesMajor Product Development OpportunitiesA. InstrumentationB. Reagent Kits and Test Systems/panelsC. Computers, Software and AutomationD. Auxiliary ProductsDesign Criteria For Decentralized Testing ProductsAlternative Market Penetration StrategiesA. Internal DevelopmentB. Collaborative ArrangementsC. University ContractsD. Distribution Strategies For Decentralized TestingMarkets1. Marketing Approaches2. Product Complexity3. Customer Preference4. Established Suppliers5. Emerging Suppliers6. Major Types Of Distributors7. Market SegmentationPotential Market Entry Barriers And RisksA. Market MaturityB. Cost ContainmentC. CompetitionD. Technological Edge And LimitationsE. Patent ProtectionF. Regulatory ConstraintsG. Decentralized Testing Market Challenges

Competitive Profiles

- Abbott

- Affymetrix

- Agilent

- Applied Gene Technologies

- Arca

- Beckman Coulter/Danaher

- Becton Dickinson

- Biokit

- BioMerieux

- Bio-Rad

- Biotest

- Caliper

- Cepheid

- Decode

- Diadexus

- Eiken

- Enzo

- Exact Sciences

- Fujirebio

- Gen-Probe

- Hologic

- Illumina

- Innogenetics/Solvay

- Kreatech

- Li-Cor Biosciences

- Life Technologies

- Monogram Biosciences

- Myriad Genetics

- Nanogen/Elitech

- Novartis

- Orchid CellMark

- Ortho-Clinical Diagnostics

- Proteome Sciences

- Qiagen

- Roche

- Scienion

- Sequenom

- Shimadzu

- Siemens

- Sierra Molecular

- Takara Bio

- Tecan Group

AppendixesAppendix I: Major Universities and Research Centers

Developing NAT Technology

Appendix II: Glossary of Terms

Appendix III: Currency Exchange Rates

List of TablesMajor Companies Developing or Marketing AIDS NAT

And Other Direct Identification Tests

Major Companies Developing or Marketing Adenovirus

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Campylobacter

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Chlamydia

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing CMV Molecular

Diagnostic And Other Direct Identification Tests

Major Companies Developing or Marketing EBV Molecular

Diagnostic And Other Direct Identification Tests

Major Companies Developing or Marketing Gonorrhea

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Hepatitis

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Herpes

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing Legionella

NAT And Other Direct Identification Tests

Major Companies Developing or Marketing LymeDisease NAT And Other Direct Identification TestsMajor Companies Developing or Marketing MycoplasmaNAT And Other Direct Identification TestsMajor Companies Developing or Marketing PapillomaVirus NAT And Other Direct Identification TestsMajor Companies Developing or Marketing PneumoniaNAT And Other Direct Identification TestsMajor Companies Developing or Marketing SalmonellaNAT And Other Direct Identification TestsMajor Companies Developing or Marketing ShigellaNAT And Other Direct Identification TestsMajor Companies Developing or Marketing StreptococciNAT And Other Direct Identification TestsMajor Companies Developing or Marketing ToxoplasmosisNAT And Other Direct Identification TestsMajor Companies Developing or Marketing TuberculosisNAT And Other Direct Identification TestsOncogenes Potential Application in Cancer DiagnosisMajor Companies Developing or Marketing CancerNAT Tests

Major Companies Developing or Marketing NAT Assays

For Genetic Diseases

Summary Table U.S.A., NAT Test Volume

And Sales Forecast by Major Application

U.S.A., Laboratories Performing

DNA Sequencing by Market Segment

U.S.A., NAT Market, Potential

Laboratory Universe by Market Segment

U.S.A., NAT Test Volume Forecast By Major Application

U.S.A., Major Infectious Disease NAT Test Volume Forecast

U.S.A., Infectious Disease Screening

NAT Volume by Test Forecast

U.S.A., NAT Market Forecast By Major Application

U.S.A., Infectious Disease Screening Nat Reagent

Market Forecast by Test

U.S.A., NAT Market by Major Supplier

U.S.A., HIV/Hepatitis C NAT Market Reagent Sales

By Major Supplier

U.S.A., West Nile Virus NAT Market Reagent Sales

By Major Supplier

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Future US Nucleic Acid Testing Market Outlook

By Molika Ashford

Researchers at Toronto's Hospital for Sick Children are forging ahead with a project to identify genomic changes that separate children with medulloblastomas into distinct groups based on differing outcomes and treatment responses.

The venture has been funded with C$9.8 million by Genome British Columbia and other partners as part of Genome Canada's Large-Scale Applied Research Project Competition, which kicked off in 2010. The research group is studying the tumors of 1,000 children using RNA sequencing and whole-genome sequencing to identify markers that can segregate the disease into distinct subgroups for personalized treatment.

The researchers hope that by identifying clear genomic subgroups in the disease and creating a test that can assess which children have these gene alterations, they will be able to treat those with the best chance of survival more conservatively — saving them painful and harmful side effects — and allow those with the worst prognosis to avoid standard regimens in favor of more experimental or less debilitating treatment.

Michael Taylor, a pediatric neurosurgeon at the hospital and one of the project's co-leaders, told PGx Reporter that medulloblastoma has a relatively high cure rate, but at severe costs to pediatric patients due to the effect that toxic and aggressive treatments have on the developing brain.

"The cure rate is between 60 and 70 percent probably, which isn't bad but really only tells half the story," he said. Standard treatment starts with aggressive brain surgery and irradiation of the entire brain and spinal cord, followed by high-dose chemotherapy, often supplemented by bone marrow transplant.

"Many kids that survive have a poor quality of life," with [lower intelligence], neurological deficits, and problems with their pituitary and thyroid. "They end up short, bald, and their bone marrow doesn't work well," Taylor said. "So even though more and more kids are being cured, the price they are paying is very large."

Taylor's group has been driving toward subgroup-based treatment of medulloblastoma through several years of microarray-based transcriptional profiling studies.

"What's become apparent over the last year or two is that this disease we used to call medulloblastoma is not really one disease but a collection of diseases that look similar under the microscope, but are epidemiologically, clinically, transcriptionally, and genetically distinct," he said.

Survival, he said, seems to differ greatly between groups, with some having really good outcomes, and others succumbing to the disease even after receiving the most aggressive treatment. With the new project, Taylor and his colleagues will deepen and expand their earlier work, using RNA sequencing and whole-genome sequencing to analyze 1,000 tumors over three years.

Taylor said the group has already begun sequencing tumors and analyzing initial sequence data. The researchers are studying tumors from the Hospital for Sick Children's own patients, as well as samples from partner institutions in the Medulloblastoma Advanced Genomics International Consortium.

He said the team hopes sequencing will allow them to discover more of the transcripts present in the disease and to identify those that may have been missed using microarrays.

"The brain has a large number of transcripts that are poorly annotated, in particular for the cerebellum, which is the part of the brain medulloblastoma grows on. So probably all kinds of genes are important for the pathogenesis of the disease and might serve as good markers for the different subgroups that we would only find by doing an unbiased approach like RNA-seq," he said.

The researchers hope to be able to select markers that can separate the groups distinctly and that they can then use to stratify patients to different treatment strategies in clinical research.

"The crux comes down to understanding the differences between groups and how many groups there are and then having biomarkers that will be reliable and will work in the setting of a clinical trial," Taylor said. "The idea being that with the [children] that have really good survival we could consider backing off on their therapy, hoping to maintain the cure rate, but decrease complications."

Meanwhile, children with a low chance of survival "should probably move sooner rather than later to more experimental therapy," he said. "There's no sense just throwing the book at them when we know it won't work."

According to Taylor, the group is also interested in gleaning information about the pathogenesis of medulloblastoma among different subgroups from mutations it discovers.

"Our early results are already starting to identify recurrent [mutation] events that are highly restricted to specific subgroups," some of which are associated with "drugs available for treatment of other neoplastic or non-neoplastic disorders," he said. "So we hope we might be able to transition those drugs rapidly to phase II for children with brain tumors."

Meanwhile, as they build a group of markers to distinguish subgroups, Taylor and his team hope within the span of the project to initiate trials of lighter treatment regimens for those groups who are either most likely to do really well without aggressive treatment, or most likely to gain little from standard treatment.

"The thing I feel really excites people about this," Taylor reflected, "is that to a certain extent for the children that have a really high survival rate, if indeed they can be cured with less therapy, we don't need to invent any new drugs. We just have to know we can identify them, and then arrange a clinical trial and just walk over to the machine and turn the dial down."

One part of the grant, he said, will go to studying whether parents will actually agree to enroll their children in such a trial or not, and whether they are willing to accept the risk of reduced treatment for potential gains in quality of life.

"It is contentious," he said. "Some people are very concerned about quality of life, some about survival rates."

"We're heading into this era of personalized medicine and I think this is a very good example of that. For families where quality is paramount, they may love this, and for those [for whom] quantity is paramount, they'll probably want to stick with standard treatment," he said.

Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at mashford [at] genomeweb [.] com.

See original here:
Genome BC Funds $9.8M Project to Identify Subgroups in Medulloblastoma for Personalized Treatment

By Turna Ray

Under a collaboration with personalized medicine-focused bioinformatics company MolecularHealth, the US Food and Drug Administration will evaluate software that will allow the agency to analyze and predict drug safety issues caused by a variety of factors, including pharmacogenomic interactions.

After evaluating the Molecular Analysis of Side Effects, or MASE, software the FDA will likely use a version of the system to gauge safety issues with marketed drugs. "The immediate plans are to use [MASE] in the post-market setting," an agency spokesperson told PGx Reporter.

MASE is a software-as-a-service offering that MolecularHealth is marketing to a variety of end users, including drug developers and payors. As reported by PGx Reporter sister publication BioInform, the company launched MASE last month (BI 1/20/2012).

MASE allows users to assess drug safety by analyzing data on therapeutic mechanisms of action, treatment-treatment interactions, as well as associations between molecular markers, diseases, and drugs in published literature. The software also includes visualization and analytical features that enable users to explore drug safety issues from a statistical or molecular perspective.

The capabilities of MASE are aligned with the FDA's expressed intent to detect and analyze drug safety issues at a mechanistic level. "The FDA Predictive Safety Team has been meeting with Molecular Health … for over a year," the agency spokesperson said, noting that the project builds on work FDA has been doing internally "for years" to mine its Adverse Event Reporting System — a computerized system to monitor drug-related adverse events — to understand mechanisms of drug toxicity.

Adverse reactions are often not detected for several years after a drug has been approved. In recent years, however, as genetic testing firms and bioinformatics companies have begun to amass large databases of molecular and phenotype data on individuals treated with a variety of drugs, the FDA has expressed a desire to use this information to detect treatment-related toxicities faster and with more precision.

The commercially available version of MASE combines patients' drug-related clinical and molecular data with information from a publicly available version of FDA's AERS. MolecularHealth has said that MASE users can use the system to analyze mechanism-based safety data for all drugs currently on the market, as well as identify potential adverse events for drugs under development.

According to the FDA spokesperson, MolecularHealth has created a new version of MASE that the company will present next month to multiple offices in the Center for Drug Evaluation and Research.

"Specific projects for collaboration will be discussed at next month's meeting," the agency spokesperson said. "The Predictive Safety Team has interest in hepatotoxicity and cardiotoxicity. Other areas of interest will likely include some focus areas related to the Sentinel Initiative."

In 2008, the FDA launched the Sentinel Initiative, under which the agency is implementing a proactive, electronic system for tracking adverse events associated with drugs, biologics, and medical devices that the agency has approved for marketing. Under this effort, the agency hopes that with a more refined mechanistic understanding of drug safety it can pick up on potential toxicity signals associated with investigational drugs and ink risk-mitigation strategies with sponsors to avoid adverse events when the drug goes on the market.

In 2010, the FDA's Advisory Committee for Pharmaceutical Science and Clinical Pharmacology held a meeting to discuss plans to build a predictive safety system that integrates pharmcogenomics, chemical structure data, and systems biology approaches to predict drug-induced adverse events before they happen (PGx Reporter 3/24/2010).

Then, last year the FDA held several drug safety workshops in which the agency discussed its intent to develop a mechanism-based drug safety assessment and prediction program. MolecularHealth's collaboration with the FDA around the MASE system evolved during that time.

MASE is exactly the type of technology that FDA has described, according to Jeffrey Marrazzo, MolecularHealth's chief business officer. "It supports not only the ability to look at adverse event information from a statistical basis, but it allows you to link understanding of how drugs work in the human system, thereby allowing you to identify, either proactively or even afterwards, safety signals with a drug," Marrazzo told PGx Reporter.

In its meeting with the FDA, MolecularHealth discussed how it could launch MASE commercially but also garner input from the agency. Marrazzo said the FDA will likely tweak the system for its own purposes.

"MASE will continue to use only the publically available AERS data at this time," the FDA spokesperson explained. "Internally, we may perform our own data-mining analyses using the in-house AERS data as a quality-control assessment."

According to the agency, its collaboration with MolecularHealth is one of several public-private partnerships focused on improving its adverse event predictive capabilities through better understanding of mechanistic-based drug safety issues. "The goal of the Predictive Safety Team is to bring together expertise from within the FDA, academia, and pharmaceutical sponsors," the agency spokesperson said. "The FDA has other Research Collaboration Agreements in place and is looking to create new RCAs."

According to the spokesperson, the agency is interested in inking additional drug safety collaborations around ontologies, cheminformatics, bioinformatics, and systems biology.

Have topics you'd like to see covered in Pharmacogenomics Reporter? Contact the editor at tray [at] genomeweb [.] com.

Read more from the original source:
FDA Evaluating MolecularHealth's MASE for Analyzing Post-Market Drug Safety

The Sree Buddha College of Engineering at Pattoor near Pandlam will be organizing a two-day international conference on Molecular Medicine on February 23 and 24.

In a statement issued here on Wednesday, Prof K. Sasikumar, Sree Buddha Education Society chairman and Dr Seema Nair.P, convener, said the conference would provide opportunity to the academic as well as student community to understand the current approaches in Molecular Medicine and discuss how these development help the future pharmaceutical innovations.

Prof V. N. Rajasekharan Pillai, Executive Vice President and Principal Secretary, Science and Technology Department, Kerala State Council for Science Technology and Environment, will inaugurate the meet on February 23 forenoon. Prof Sasikumar will preside the function.

Dr C. Adithan, Professor and Head, ICMR Centre for Advanced Research in Pharmacogenomics, Department of Pharmacology, JIPMER, Pondicherry, willdeliver the keynote address on Pharmacogenomics at 10.45 am on February 23.

Dr Min-Tze Liong attached to Bioprocess Technology Division of School of Industrial Technology, Universiti Sains Malaysia in Penang, will deliver the plenary lecture on Probiotics Cholesterol and Blood, later.

Dr D. Karunagaran of Department of Biotechnology at Indian Institute of Technology in Chennai will talk on Role of micro RNAs in cancer in the afternoon.

Dr Annie John from TEM Laboratory, BMT WING, SCTIMST in Thiruvananthapuram will deliver a lecture on Regenerative Medicine, later at 2.15 pm.

Invited Lectures on Molecular Medicine for Disease Diagnosis and Biomaterials for Regenerative Engineering will be held on February 24 forenoon.

Dr K. Sudesh Kumar, School of Biological Sciences, Universiti Sains Malaysia in Penang will talk on ‘Fabrication of electrospun Polyhydroxyalkanoate and its application in Medicine and Environmental conservation’, later, in the afternoon. Further details regarding the conference are available at 04792375440, 41, Dr Seema said.

Continue reading here:
SBCE to organise international meet on Molecular Medicine

Protein-folding might not sound like an especially exhilarating way to spend a weekend, but puzzle mavens and scientific researchers alike rallied behind the game’s innovative take on crowd-sourcing public ingenuity to tackle scientific conundrums. The effort has long since paid off, but this year the game adds another feather to its cap: taking top honors at the ninth annual International Science and Engineering Visualization Challenge, with a first place win in the Interactive Games category.

The Challenge’s goal is a novel one. The journal Science and the National Science Foundation have teamed up to reward and promote especially novel ways of sharing data and scientific knowledge with the general public. This was the first year that included a specific Interactive Games category; other categories offer accolades for noteworthy photography, videos, and informational posters and graphics. The winners were chosen by an outside panel of experts, but there was also public voting on the National Science Foundation’s website for the People’s Choice award. All of the games have large educational components, and many were designed for students or use in classrooms.

In Foldit, players earn points by arranging protein structures into feasible, realistic shapes. The shapes players design help researchers understand how proteins fold, which is critical to identifying proteins in cells. Although most of protein folding research is computer automated, machines aren’t as efficient as humans when it comes to pattern recognition and puzzle-solving. The developers take advantage of this fact; players are both solving structures and helping to teach computers to be better folders.

There were plenty of other games in the running. The People’s Choice award went to a quirky little title called Velu the Welder. It’s designed to be played with a Nintendo Wii controller, using motion controls to teach basic welding lessons. As they improve, players can move to arc welding or some basic building. It was developed by Tata Consultancy Services in India, to provide training and help school dropouts develop marketable skills.

Another noteworthy entry was Meta!Blast 3D. It’s an action game, a bit reminiscent of The Magic School Bus, without Ms. Frizzle. A lab’s personnel have become trapped inside of a photosynthetic cell, and it’s up to you to rescue them. That involves navigating through the cell, learning about its different features, and surviving attacks from nefarious proteins like ubiquitin (the “kiss of death” protein). This has yet to occur in any of the labs I’ve worked in, but I find it nice to be prepared.

You can find the full list of games in this month’s issue of Science, or at their website. And be sure to check out the rest of the entries; there’s some cool stuff in there.

Julia Seaman is a graduate student, working on a Ph.D in Pharmacogenomics. When she isn’t futzing with the mass spectrometer or harvesting cells, you can find her cruising the space lanes in The Old Republic.

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Gaming Wins Big at National Science Foundation's Visualization Challenge

NEW YORK, NY--(Marketwire -02/02/12)- TriMarkPublications.com cites in its newly published "Companion Diagnostics in Personalized Medicine and Cancer" report that the companion diagnostics market will explode as the personalized medicine market catapults to $42 billion by 2015. For more information, visit: http://www.trimarkpublications.com/products/Companion-Diagnostics-in-Personalized-Medicine-and-Cancer-Therapy.html.

Companion diagnostics is the use of genetic variation (e.g., SNPs, gene expression variability and other molecular signatures) to detect different patient responses to particular drugs or biologic agents in order to understand and correlate their individual differential responses to pharmaceutical agents. Companion diagnostics can be deployed clinically to stratify patients based on their response to certain therapeutic agents, known as personalized medicine, and companion diagnostics will also play an increasingly important role in cancer treatments over the forecast period.

The "Companion Diagnostics in Personalized Medicine and Cancer" report covers:

Epidermal Growth Factor Receptor Assay, Individualized Warfarin Therapy and other uses of companion diagnostics in clinical situations IVDMIA, Irinotecan and UGT1A1, Tyrosine Kinase and other cancer biomarker tests MGMT Methylation Assay and other pharmacogenomics tests Recurrence prediction tests Blood-based technologies Proteomics Personalized Medicine Coalition (PMC) Health Insurance Portability and Accountability Act (HIPPA) Clinical Laboratory Improvement Amendments (CLIA)

The "Companion Diagnostics in Personalized Medicine and Cancer" report examines companies manufacturing companion diagnostics equipment and supplies in the world. Companies covered include: 20/20 GeneSystems, Abbott, Affymetrix, Agendia, Agilent, Almac, AMDL, Applied, Asuragen, Aureon, BD, Beckman Coulter, BioCurex, Biomarker, Biomedical, Biomerica, bioMérieux, Biomira, BioModa, Clarient, Claros, Correlogic, CytoCore, Cytogen, Dako, DiaDexus, DiagnoCure, DRG, EDP, Eisai, EXACT, Exagen, Gene Logic, Genesis, Genomic, Health Ikonisys, Illumina, Incyte, InterGenetics, Ipsogen, Johnson & Johnson, LabCorp, Life, Matritech, Miraculins, Monogram, Myriad, NimbleGen, Northwest, Nycomed, Oncotech, Oncothyreon, Orion, Oxford, Polymedco, Power3, Prometheus, Proteome, Qiagen, Roche, SensiGen, Siemens, SuperArray, Tosoh, TrimGen, Upstream, Veridex, Vermillion and Vertex.

Detailed charts with sales forecasts and marketshare data are included. For more information, visit: http://www.trimarkpublications.com/products/Companion-Diagnostics-in-Personalized-Medicine-and-Cancer-Therapy.html.

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Important Notice

The statements contained in this news release that are forward-looking are based on current expectations that are subject to a number of uncertainties and risks, and actual results may differ materially.

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Companion Diagnostics Market to Explode as Personalized Medicine Market Catapults to $42 Billion by 2015