感染疾病分子診斷的技術創新

感染疾病分子診斷的技術創新 是由出版商Business Insights在2011年11月所出版的。 這份英文市場調查報告書包含Pages: 168 價格從美金3835起跳。

簡介

進入發展期的最新的分子診斷技術，由少量的試料中存在的幾個病原體以及可以檢測的變異體的多重檢驗所構成。低以及中密度的磁珠珠微陣列技術也正在開發，兩者皆對多重病原體檢測和遺傳基因型判斷發揮重要作用。

本報告提供新生·變異病原體及新分子檢驗技術的醫療相關感染(人類乳突病毒感染，血源性的病毒感染，呼吸系統的病毒感染等)領域的優秀的的診斷產品方法的出現，分子診斷技術開發商的機會分析·驗證的調查資訊彙整，為您概述為以下內容。

摘要整理

• 分子診斷技術
• 醫療相關感染
• 性病
• HIV及肝炎病毒
• 病毒性呼吸疾病
• 市場展望及預測

關於作者

• 免責聲明

分子診斷技術

• 摘要
• 感染疾病的分子診斷所扮演的角色
• 核酸檢驗(NAT)
• 核酸擴增的技術創新
• 自動化NAT平台
• 微流體工程
• 數位PCR
• 核酸微陣列的技術創新
• 新一代測序的技術創新
• 質量分析法的技術創新
• 蛋白質排列的技術創新

醫療相關感染

• 摘要
• 藥物抗性病原體的問題
• Clostridium difficile（困難腸梭菌）
• 萬古霉素抗藥性腸球菌(VRE)
• 血液中的病原體

性病

• 摘要
• 人類乳突病毒(HPV)感染疾病
• 人類乳突病毒(HPV)基因
• 子宮頸癌篩檢
• 人類乳突病毒(HPV)檢驗的「分析」V.S.「治療」的敏感性
• 臨床材料中的遺傳基因型判斷人類乳突病毒(HPV)
• 疫苗接種與檢查的影響
• 市售及開發中的產品
• 標的擴增技術
• 信號擴增技術
• 人類乳突病毒(HPV) mRNA的檢測

HIV及肝炎病毒

• 摘要
• 簡介
• HIV感染
• HIV病毒數量檢驗
• 藥物抗性檢驗
• B型肝炎病毒(HBV)感染
• C型肝炎病毒(HCV)感染
• 美國食品醫藥品局(FDA)核准血液篩檢檢驗
• 潛在HBV·HCV感染

病毒性呼吸疾病

• 摘要
• 簡介
• 重要呼吸系統病毒
• 多重呼吸系統病檢體組
• 流感病毒檢體組
• 呼吸系統病檢體組

市場展望及預測

• 摘要
• 簡介
• 多重MDx技術趨勢

目錄

Description

INTRODUCTION

This report examines the opportunities presented to the developers of molecular diagnostics by the emergence of novel/variant pathogens and ways in which new molecular testing technologies are being translated into superior diagnostic products in areas such as healthcare-associated infections; HPV infections, blood-borne viral infections and respiratory viral infections.

FEATURES AND BENEFITS

• Understand the nature and limitations of traditional molecular diagnostics and the improved features of molecular testing technologies in development.
• Evaluate the competitive landscape in infectious disease molecular diagnostics and identify potential licensing/collaborative partners.
• Analyze the factors stimulating increased demand for molecular testing in specific infectious disease areas to inform investment decisions.
• Gain an insight into new and untapped opportunities revealed by recent research findings in the more mature sectors of the MDx market.
• Identify key trends in the MDx market and plan future developments with the aid of market forecasts for the individual segments of the market.

HIGHLIGHTS

The latest molecular diagnostics to enter development are multiplex tests which can identify several pathogens or variants of these pathogens present in small-volume samples. Low- and medium-density bead-based microarrays are being developed and are expected to play an increasingly important role in multiplex pathogen detection and genotyping.

It is likely that future diagnostic tests will target many more pathogens than is currently the case. Promising approaches include miniaturized microfluidic systems, in particular continuous-flow droplet-based PCR systems, and mass spectrometry-based detection methods which use direct specimen testing and virtually no reagents.

Growth forecasts are derived for key MDx market segments for the period 2010-2015: the HPV testing market is forecast to grow with a 5-year CAGR of 20%, the hospital-associated infection (HAI) testing market is forecast to grow with a 5-year CAGR of 19%. and the virology (HIV/HCV/HBV) testing market is forecast to grow with a 5-year CAGR of 8%.

YOUR KEY QUESTIONS ANSWERED

• Which are the areas of unmet need in infectious disease testing and potential new areas of opportunity for MDx in infectious disease?
• What forces are shaping molecular diagnostic testing trends and what drivers and restraints operate in the infectious disease testing market?
• Who is developing new innovative products for the infectious disease MDx market and what paths to commercialization are they following?
• How are the different sectors of the infectious disease MDx market forecast to develop and what are the prospects for new market entrants?
• What are the estimated current market sizes and 5-year growth forecasts for the expanding sectors of the infectious disease MDx market?

Table of Contents

Executive Summary

• Molecular diagnostic technologies
• Healthcare-associated infections
• Sexually transmitted HPVs
• HIV and hepatitis viruses
• Viral respiratory pathogens
• Market outlook and forecasts

About the author

• Disclaimer

Molecular diagnostic technologies

• Summary
• Role of molecular diagnostics in infectious diseases
• Overview of nucleic acid testing (NAT)
• Sample processing
• Probe-based testing
• Innovations in nucleic acid amplification technologies
• PCR-based amplification technologies
• Alternative amplification technologies
• Automated platforms for NAT
• Point-of-care real-time PCR testing systems
• Microfluidics
• Digital PCR
• Innovations in nucleic acid microarrays
• Development of microarray formats
• Suspension bead and other 3D arrays
• Innovations in next-generation sequencing
• Innovations in mass spectrometry methods
• Innovations in protein arrays

Healthcare-associated infections

• Summary
• The challenge of drug-resistant pathogens

MRSA

• Culture vs. nucleic acid tests
• FDA-approved nucleic acid tests
• Examples of technologies and products in development
• Clostridium difficile
• Traditional tests
• FDA approved nucleic acid tests
• Vancomycin-resistant enterococci (VRE)
• Culture and nucleic acid tests
• Bloodstream pathogens
• Blood culture
• Microorganisms found in blood cultures
• FDA-approved nucleic acid tests
• Amplification-based products in development
• Mass spectrometry-based products in development

Sexually transmitted HPVs

• Summary
• HPV infections
• The HPV genome
• Screening for cervical cancer
• Analytical versus clinical sensitivity of HPV tests
• Genotyping HPV in clinical specimens
• Vaccination and implications for testing
• Products on the market and in development
• Target amplification techniques
• Reverse line blot and linear array tests
• Amplicor
• PapilloCheck
• Bead-based assays
• Assays using real-time PCR amplification
• Signal amplification techniques
• Hybrid Capture 2 assay (FDA-approved)
• Cervista (FDA-approved)
• Detection of HPV mRNA
• Nuclisens
• Aptima HPV (FDA-approved)

HIV and hepatitis viruses

• Summary
• Introduction
• HIV infections
• Characteristics of HIV
• HIV testing strategies
• HIV load testing
• FDA-approved assays
• Tests in development
• Digital PCR approach
• Drug resistance testing
• HBV infections
• Characteristics of HBV
• HBV load testing
• Drug resistance testing
• Detection of co-infecting HDV
• HCV infections
• Characteristics of HCV
• HCV load testing
• Drug resistance and drug efficacy testing
• FDA-approved blood screening tests
• Occult HBV and HCV infections
• HCV-RNA assays
• HBV-DNA assays

Viral respiratory pathogens

• Summary
• Introduction
• Important respiratory viruses
• Influenza A/B viruses
• Respiratory syncytial virus
• Human parainfluenza virus
• Adenovirus 1
• Rhinovirus
• Emerging respiratory viruses
• Avian influenza and influenza A swine flu
• SARS-covirus and other human coronaviruses
• Human metapneumovirus
• Human bocavirus
• Multiplex respiratory virus panels
• Influenza virus panels
• Respiratory virus panels
• Luminex's xTAG RVP
• Qiagen's RespPlex II
• EraGen Biosciences' MultiCode-PLx RVP
• Comparison of xTAG, ResPlex II, and MultiCode-Plx
• AutoGenomics' Infiniti System
• Seegene's Seeplex RP Assay
• Idaho's real-time PCR FilmArray
• BD's real-time PCR Jaguar System
• PrimeraDx's quantitative PCR STAR technology
• Abbott's PLEX-ID for pathogen discovery

Market outlook and forecasts

• Summary
• Introduction
• MDx opportunities in viral hemorrhagic fevers
• MDx opportunities in other emerging pathogens
• Multiplexed MDx technology trends
• Microarrays and microfluidic devices
• Mass spectrometry

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