This 860-page report provides a comprehensive analysis of the Japanese molecular diagnostics market, including major trends, technologies, applications, and key players. It forecasts test volumes and reagent sales for infectious diseases, genetic diseases, cancer, and other applications. The report profiles leading suppliers and identifies over 60 business opportunities in molecular diagnostic instruments, tests, software, and auxiliary products. It also examines market entry barriers, alternative strategies, and concerns for companies operating in this space.
Next Generation Companion Diagnostics; Adoption, Drivers, and Moderators of N...Andrew Aijian
Analysis and synthesis of a pulse survey conducted across >140 oncologists, pathologists, and lab directors regarding current adoption and trends associated with emerging oncology biomarkers and companion diagnostics (CDx), with an emphasis on next-generation sequencing (NGS)-based CDx.
Clinical Validation of Copy Number Variant Detection by Next-Generation Seque...Golden Helix
Despite the great advances achieved in clinical genetics thanks to the incorporation of NGS (Next Generation Sequencing), a significant percentage of patients with diseases of genetic origin still do not have a conclusive molecular diagnosis. The incorporation of state-of-the-art bioinformatic methods has allowed the implementation of CNVs (Copy Number Variants) detection in NGS analysis, improving its diagnostic efficiency. In this study, the clinical utility of the detection of CNVs by NGS has been proven.
During 2018, 275 patients were studied using the NGS technique without obtaining an accurate genetic diagnosis. Bioinformatic tools that compare the normalized sequencing depth between patients and controls were used to determine CNVs. The results obtained were compared with patients own laboratory database and controls to rule out polymorphisms and false positives. All causal CNVs were confirmed by MLPA.
Pathogenic CNVs causing the disease were detected in 11 of the 275 patients (4%). Specifically, CNVs were detected for pathologies with autosomal dominant inheritance patterns (TSC2, MSH2, and FBN1), as well as for genes with autosomal recessive inheritance patterns, including two homozygous deletions (KCNV2 and RDX) and one heterozygous deletion with an SNV (Single Nucleotide Variant) in the PKHD1 gene. One of the most notable cases corresponds to a patient suspected of hypomagnesemia in which two deletions were identified in compound heterozygous mutation in the TRPM6 gene.
This slides briefly introduced why car t cell validation assay is essential for car t therapy development and which assays should be done to validate the safety, identity, purity and potency of car t cell products.
This presentation (in English) made at ONCOTRANS in Besançon on Friday 3rd 2017 reviews the potential for TGF-beta inhibition in hepatocellular carcinoma based on preclinical and clinical data.
Integrating Disruptive Technologies Into Translational Research Hinxton Hal...Mike Romanos
Introduction to a session with the same title. Addresses the challenges in drug discovery and how disruptive technologies can help. Focusses on use of RNAi and stem cells in translational studies
“Regulatory experience with monoclonal antibody submissions in the EU”
Provides an overview of the current EU assessment of biotherapeutics, focusing specifically on monoclonal antibodies
The He Jiankui affair is a scientific and bioethical controversy concerning the use of genome editing following its first use in humans by Chinese scientist He Jiankui, involving the human germline editing. This presentation emphasizes on the ethical issues of the incident.
Welcome to watch Creative Biolabs’ slide about immune system and immune therapy. here we share some basic knowledge about T Cell Receptor Engineered T Cell Technology or TCR-T and its application on tumor therapy.
Clinical Validation of Copy Number Variants Using the AMP GuidelinesGolden Helix
The common approaches to detecting copy number variants (CNVs) are chromosomal microarray and MLPA. However, both options increase analysis time, per sample costs, and are limited to the size of CNV events that can be detected. VarSeq’s CNV caller, on the other hand, allows users to detect CNVs from the coverage profile stored in the BAM file, which allows you to utilize your existing NGS data and perform the analysis all in one suite. Coupled with this innovative feature is the ability to annotate CNV events against a variety of databases, and by incorporating our VSClinical AMP workflow, we can now assess CNVs as potential biomarkers. Most importantly, Golden Helix CancerKB is an AMP workflow feature that provides expert-curated biomarker interpretations, including those for common somatic CNVs, that will streamline the analysis time and report generation.
In this demonstration we will cover:
Setting up the VS-CNV caller using BAM files from whole exome data
Filtering down to high quality, high confidence CNV events
Annotating CNVs using publicly curated catalogs and databases
Adding clinically relevant CNVs to the VSClinical AMP workflow
Utilizing Golden Helix CancerKB to obtain expert-curated interpretations
Showing updated features and polishes to the software
Together, VarSeq incorporates the ability to accurately call and annotate CNVs and evaluate germline and somatic mutations according to the ACMG and AMP guidelines, respectively. This webcast demonstration will provide insight into these best practice workflows and will hopefully show you how you can implement this top-quality software into your pipeline solution.
Next Generation Companion Diagnostics; Adoption, Drivers, and Moderators of N...Andrew Aijian
Analysis and synthesis of a pulse survey conducted across >140 oncologists, pathologists, and lab directors regarding current adoption and trends associated with emerging oncology biomarkers and companion diagnostics (CDx), with an emphasis on next-generation sequencing (NGS)-based CDx.
Clinical Validation of Copy Number Variant Detection by Next-Generation Seque...Golden Helix
Despite the great advances achieved in clinical genetics thanks to the incorporation of NGS (Next Generation Sequencing), a significant percentage of patients with diseases of genetic origin still do not have a conclusive molecular diagnosis. The incorporation of state-of-the-art bioinformatic methods has allowed the implementation of CNVs (Copy Number Variants) detection in NGS analysis, improving its diagnostic efficiency. In this study, the clinical utility of the detection of CNVs by NGS has been proven.
During 2018, 275 patients were studied using the NGS technique without obtaining an accurate genetic diagnosis. Bioinformatic tools that compare the normalized sequencing depth between patients and controls were used to determine CNVs. The results obtained were compared with patients own laboratory database and controls to rule out polymorphisms and false positives. All causal CNVs were confirmed by MLPA.
Pathogenic CNVs causing the disease were detected in 11 of the 275 patients (4%). Specifically, CNVs were detected for pathologies with autosomal dominant inheritance patterns (TSC2, MSH2, and FBN1), as well as for genes with autosomal recessive inheritance patterns, including two homozygous deletions (KCNV2 and RDX) and one heterozygous deletion with an SNV (Single Nucleotide Variant) in the PKHD1 gene. One of the most notable cases corresponds to a patient suspected of hypomagnesemia in which two deletions were identified in compound heterozygous mutation in the TRPM6 gene.
This slides briefly introduced why car t cell validation assay is essential for car t therapy development and which assays should be done to validate the safety, identity, purity and potency of car t cell products.
This presentation (in English) made at ONCOTRANS in Besançon on Friday 3rd 2017 reviews the potential for TGF-beta inhibition in hepatocellular carcinoma based on preclinical and clinical data.
Integrating Disruptive Technologies Into Translational Research Hinxton Hal...Mike Romanos
Introduction to a session with the same title. Addresses the challenges in drug discovery and how disruptive technologies can help. Focusses on use of RNAi and stem cells in translational studies
“Regulatory experience with monoclonal antibody submissions in the EU”
Provides an overview of the current EU assessment of biotherapeutics, focusing specifically on monoclonal antibodies
The He Jiankui affair is a scientific and bioethical controversy concerning the use of genome editing following its first use in humans by Chinese scientist He Jiankui, involving the human germline editing. This presentation emphasizes on the ethical issues of the incident.
Welcome to watch Creative Biolabs’ slide about immune system and immune therapy. here we share some basic knowledge about T Cell Receptor Engineered T Cell Technology or TCR-T and its application on tumor therapy.
Clinical Validation of Copy Number Variants Using the AMP GuidelinesGolden Helix
The common approaches to detecting copy number variants (CNVs) are chromosomal microarray and MLPA. However, both options increase analysis time, per sample costs, and are limited to the size of CNV events that can be detected. VarSeq’s CNV caller, on the other hand, allows users to detect CNVs from the coverage profile stored in the BAM file, which allows you to utilize your existing NGS data and perform the analysis all in one suite. Coupled with this innovative feature is the ability to annotate CNV events against a variety of databases, and by incorporating our VSClinical AMP workflow, we can now assess CNVs as potential biomarkers. Most importantly, Golden Helix CancerKB is an AMP workflow feature that provides expert-curated biomarker interpretations, including those for common somatic CNVs, that will streamline the analysis time and report generation.
In this demonstration we will cover:
Setting up the VS-CNV caller using BAM files from whole exome data
Filtering down to high quality, high confidence CNV events
Annotating CNVs using publicly curated catalogs and databases
Adding clinically relevant CNVs to the VSClinical AMP workflow
Utilizing Golden Helix CancerKB to obtain expert-curated interpretations
Showing updated features and polishes to the software
Together, VarSeq incorporates the ability to accurately call and annotate CNVs and evaluate germline and somatic mutations according to the ACMG and AMP guidelines, respectively. This webcast demonstration will provide insight into these best practice workflows and will hopefully show you how you can implement this top-quality software into your pipeline solution.
This is a PowerPoint presentation shared recently by members of Roanoke's U.Lab Hub 2.0 at a lunch meeting with staff from Transitional Options for Women.
Avoid email meltdown through segementation (web edit)Purple Vision
At #CHASE15, Steve Thomas from Purple Vision spoke to the title Avoid Email Meltdown - how segmentation can improve response, retention and reputation.
The session covered the segmentation variables that charities and non profits can adopt with their email list to both grow their audience and communicate more meaningfully with their supporters, potential supporters and other stakeholders.
Italian Microbiology Testing Market: Innovative Technologies and Emerging Bus...
Japan Molecular Diagnostics Market: Innovative Technologies and Emerging Business Opportunities
1. Japan Molecular Diagnostics Market: Innovative Technologies
and Emerging Business Opportunities
Report Details:
Published:December 2012
No. of Pages: 860
Price: Single User License – US$7500
This report presents a comprehensive analysis of the Japanese molecular diagnostics
market, including:
•Major issues pertaining to the Japanese molecular diagnostics 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 - Genetic Diseases - Cancer - Paternity Testing/HLA TypingForensic
Testing
•Review of testing methodologies an instrumentation technologies.
•Feature comparison of automated and semiautomated analyzers.
•Sales and market shares of leading suppliers.
•Over 60 specific opportunities for molecular diagnostic 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.
Get your copy of this report @
http://www.reportsnreports.com/reports/211042-japan-molecular-diagnostics-market-innovative-technologies-and-
emerging-business-opportunities.html
Major points covered in Table of Contents of this report include
Table of Contents
Introduction
2. 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
Polymerase Chain Reaction
Temperature Cyclers
PCR Variations
Immun-PCR
QC-PCR
DAP-PCR
Strand Displacement Activation
TMA
Ligase Chain Reaction
Branched DNA
Hybridization Protection Assay
Nucleic-Acid Sequence-Based Amplification
Self-Sustained Sequence Replicase
3. Others
Ampliprobe
CAR
CAS
CPT
Dendritic Polymer Technology
IS-CR
LAT
Probe Networks
RAMP
Repair Chain Reaction
Rolling Circles
Sequence Independent Gene Amplification
Sequence Initiation Reaction
SISPA
Solid Phase Amplification
C. Detection Technologies
1. Radioactive Methods
a. Overview
b. Major Isotopes
P-32
S-35
H-3
I-125
2. Non-Isotopic Methods
a. Enzymatic Labels
b. Chemical Labeling
Indirect Chemical Labeling
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. Bi-Rad GeneScope
5. Gen-Probe Tigris
6. Roche Cobas Amplicor
7. Tecan LS Series
E. Biochips: Genosensors, Microarrays, and
Labs-on-the-Chip
4. Liquid Transportation and Mixing
Separation
Reaction
Detection
F. Pharmacogenomics
G. Major Applications
1. Microbiology/Infectious Diseases
a. Overview
b. Major Infectious Diseases
AIDS
Structure and Composition
Classification
AIDS Origins
Animal Lentivirus Systems
Virus Receptors
HIV Infections in Humans
Pathogenesis and Pathology
CD4T Lymphocytes and Memory Cells
Monocytes and Macrophages
Lymphoid Organs
Neural Cells
Viral Coinfections
Clinical Findings
Plasma Viral Load
Pediatric AIDS
Neurologic Disease
Opportunistic Infections
Cancer
Immunity
Virus Isolation
Serology
Viral Nucleic Acid/Antigen Detection
Epidemiology
Worldwide Spread of AIDS
United States
Routes of Transmission
DNA Probes
Overview
Quantitative PCR
In Situ PCR
Needed Improvements
Viral Load/Drug Resistance Testing
5. Genotype and Phenotype Testing
Blood Banking Considerations
Adenovirus
Background
Diagnostic Tests
Vaccines and Drugs
Aden-Associated Viruses (AAV)
Anthrax/Bacillus Anthracis
Background
Diagnostic Tests
Vaccines and Drugs
Babesiosis
Background
BEA and Other Bartonella Diseases
Background
Diagnostic Tests
Vaccines and Drugs
Chagas Disease
Background
Campylobacter
Background
Diagnostic Tests
Culture Identification
Vaccines and Drugs
Chlamydia
Background
Chlamydia psittaci
Chlmaydia pneumoniae
Chlamydia trachomatis
Diagnostic Tests
Vaccines and Drugs
Creutzfeldt-Jakob’s Disease
Background
Blood Transmission
Diagnostic Tests
Major Commercial and Academic Players
Bayer
Disease Sciences/BiTec Global
Imperial College School of Medicine
Orth-Clinical Diagnostics
Pall
ProMetic Life Sciences
6. Proteome Sciences/Idexx
Q-One Biotech
SeronU.S. Agricultural Research Service
Drugs
Vaccines
Cytomegalovirus
Background
Chorioretinitis
Gastrointestinal
Central Nervous System Disease
Diagnostic Tests
Vaccines and Drugs
Ebola Virus
Background
Epidemiology
Clinical Syndromes
Diagnostic Tests
Vaccines and Drugs
EchoVirus
Background
Acute Aseptic Meningitisis
Encephalitis
Exanthems
Respiratory Disease
Myopericarditis
Neonatal Infections
Diagnostic Tests
Vaccines and Drugs
Encephalitis
Background
Diagnostic Tests
Vaccines and Drugs
Enteroviruses
Background
Diagnostic Tests
Viral Isolation and Identification
Antibody Tests
Vaccines and Drugs
Epstein-Barr Virus
Background
Diagnostic Tests
Vaccines and Drugs
7. Gonorrhea
Background
Diagnostic Tests
Vaccines and Drugs
Hepatitis
Hepatitis A
Hepatitis B
Structure and Composition
Replication
Hepatitis C
Hepatitis D (Delta)
Hepatitis E
Hepatitis G
Hepatitis Infections Pathology
Clinical Findings
Laboratory Tests
Hepatitis A
Hepatitis B
Hepatitis C
Hepatitis D
Hepatitis E
Virus-Host Immune Reactions
Epidemiology
Hepatitis A
Hepatitis B
Hepatitis C
Hepatitis D (Delta)
Vaccines and Drugs
Herpes Simplex Virus
Background
Diagnostic Tests
Vaccines and Drugs
Legionella
Background
Diagnostic Tests
Vaccines and Drugs
Lyme Disease
Background
Clinical Description
Clinical Case Definition
Laboratory Criteria for Diagnosis
Case Classification
8. Diagnostic Tests
Vaccines and Drugs
Malaria
Mycoplasma
Background
Ureaplasma Urealyticum & Mycoplasma
Hominis
Diagnostic Tests
Vaccines and Drugs
Papillomaviruses/HPV
Background
HPV in Cancer
Cervical Neoplasm
Diagnostic Tests
Vaccines and Drugs
Prevention
Parvovirus B19
Background
Microbiology
Epidemiology
Clinical Syndromes
Erythema Infectiosum (Slapped Cheek)
Adult Polyarthropathy
Transient Aplastic Crisis
Transient Pancytopenia
Red Cell Aplasia in Immunocompromised
Perinatal Infections
Diagnostic Test
Vaccines and Drugs
Pneumonia
Background
Diagnostic Tests
Vaccines and Drugs
Polyomaviruses
Background
Diagnostic Tests
Vaccines and Drugs
Salmonellosis
Background
Diagnostic Tests
Vaccines and Drugs
Shigellosis
9. Background
Diagnostic Tests
Vaccines and Drugs
Streptococci
Background
Diagnostic Tests
Vaccines and Drugs
Group A Streptococci
Group B Streptococci
Toxoplasmosis
Background
Diagnostic Tests
Vaccines and Drugs
Tuberculosis
Background
Diagnostic Tests
Microscopic Characteristics
Cultural Characteristics
Skin Tests
MDRTB
Vaccines and Drugs
West Nile Virus
Background
Clinical Syndromes
Diagnostic Tests
Vaccines and Drugs
Yersinia
Background
Diagnostic Tests
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
10. c. Oncogenes
Abl/abl-bcr
AIB1
BCL-2
BRCA1
CD44
C-fos
C-myb
C-myc
CYP17
Erb-B
HPC1
N-myc
P40
P51
P53
PIK3CA
PTI-1
Ras
Reg
Sis
Src
3. Genetic Diseases
a. Overview
b. Nucleic Acid Amplification
c. Chromosome Imaging
d. Genomics Technologies
e. Proteomics Technologies
f. Current Pharmacogenomic Tests
g. Future Pharmacogenomic Testing
h. Major Diseases
Achondroplasia
Autosomal Dominant Polycystic Kidney
Disease
Cancer
Cosmetogenomics
Cystic Fibrosis
Down's Syndrome
Duchenne and Becker Muscular Dystrophy
Factor V (Leiden)
Factor IX Deficiency
Fragile X Syndrome
11. 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 tthe 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
12. i. Other
H. Competing/complementing Technologies
1. Monoclonal Antibodies/Immunoassays
2. RNA Probes
3. Tw-Dimensional Electrophoresis
4. Flow Cytometry
Japan
A. Executive Summary
B. Business Environment
C. Market Structure
D. Market Size, Growth And Major Suppliers’ Sales And Market Shares
Major Product Development Opportunities
A. Instrumentation
B. Reagent Kits and Test Systems/panels
C. Computers, Software and Automation
D. Auxiliary Products
Design Criteria For Decentralized Testing Products Alternative Market Penetration
Strategies
A. Internal Development
B. Collaborative Arrangements
C. University Contracts
D. Distribution Strategies For Decentralized Testing
Markets
1. Marketing Approaches
2. Product Complexity
3. Customer Preference
4. Established Suppliers
5. Emerging Suppliers
6. Major Types Of Distributors
7. Market Segmentation
Potential Market Entry Barriers And Risks
A. Market Maturity
B. Cost Containment
C. Competition
D. Technological Edge And Limitations
E. Patent Protection
F. Regulatory Constraints
G. Decentralized Testing Market Challenges
Competitive Profiles
Abbott
Affymetrix
Agilent
14. List of Tables
Major Companies Developing or Marketing AIDS Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Adenovirus Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Campylobacter Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Chlamydia Molecular Diagnostic 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 Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Hepatitis Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Herpes Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Legionella Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Lyme Disease Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Mycoplasma Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Papilloma Virus Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Pneumonia Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Salmonella Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Shigella Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Streptococci Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Toxoplasmosis Molecular Diagnostic And Other Direct
Identification Tests
Major Companies Developing or Marketing Tuberculosis Molecular Diagnostic And Other Direct
Identification Tests
Oncogenes Potential Application in Cancer Diagnosis
Major Companies Developing or Marketing Cancer Molecular Diagnostic Tests
Major Companies Developing or Marketing Molecular Diagnostic Test For Genetic Diseases
15. Summary Table Japan, Molecular Diagnostics Test Volume And Sales Forecast by Major
Application
Japan, Laboratories Performing DNA Sequencing by Market Segment
Japan, Molecular Diagnostics Market Potential Laboratory Universe by Market Segment
Japan, Molecular Diagnostics Test Volume Forecast By Major Application
Japan, Major Infectious Disease Molecular Diagnostics Test Volume Forecast
Japan, Infectious Disease Screening NAT Volume Forecast
Japan, Molecular Diagnostics Market Forecast By Major Application
Japan, Infectious Disease Screening Nat Reagent Market Forecast by Test
Japan, Molecular Diagnostics Market By Major Supplier
Japan, HIV/Hepatitis NAT Market Reagent Sales by Major Supplier
Contact: sales@reportsandreports.com for more information.