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Innovations in Molecular Diagnostics for Infectious Diseases
Published on November 2011

                                                                                                              Report Summary

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



Innovations in Molecular Diagnostics for Infectious Diseases (From Slideshare)                                                    Page 1/6
Find Industry reports, Company profiles
ReportLinker                                                                            and Market Statistics
                                               >> Get this Report Now by email!

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 Content

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



Innovations in Molecular Diagnostics for Infectious Diseases (From Slideshare)                                             Page 2/6
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ReportLinker                                                                            and Market Statistics
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  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



Innovations in Molecular Diagnostics for Infectious Diseases (From Slideshare)                                     Page 3/6
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  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




Innovations in Molecular Diagnostics for Infectious Diseases (From Slideshare)                                     Page 4/6
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Innovations in Molecular Diagnostics for Infectious Diseases

  • 1. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! Innovations in Molecular Diagnostics for Infectious Diseases Published on November 2011 Report Summary 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 Innovations in Molecular Diagnostics for Infectious Diseases (From Slideshare) Page 1/6
  • 2. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! 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 Content 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 Innovations in Molecular Diagnostics for Infectious Diseases (From Slideshare) Page 2/6
  • 3. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! 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 Innovations in Molecular Diagnostics for Infectious Diseases (From Slideshare) Page 3/6
  • 4. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! 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 Innovations in Molecular Diagnostics for Infectious Diseases (From Slideshare) Page 4/6
  • 5. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! Fax Order Form To place an order via fax simply print this form, fill in the information below and fax the completed form to: Europe, Middle East and Africa : + 33 4 37 37 15 56 Asia, Oceania and America : + 1 (805) 617 17 93 If you have any questions please visit http://www.reportlinker.com/notify/contact Order Information Please verify that the product information is correct and select the format(s) you require. Innovations in Molecular Diagnostics for Infectious Diseases Product Formats Please select the product formats and the quantity you require. 1 User License--USD 3 835.00 Quantity: _____ Corporate License--USD 14 381.25 Quantity: _____ Contact Information Please enter all the information below in BLOCK CAPITALS Title: Mr Mrs Dr Miss Ms Prof First Name: _____________________________ Last Name: __________________________________ Email Address: __________________________________________________________________________ Job Title: __________________________________________________________________________ Organization: __________________________________________________________________________ Address: __________________________________________________________________________ City: __________________________________________________________________________ Postal / Zip Code: __________________________________________________________________________ Country: __________________________________________________________________________ Phone Number: __________________________________________________________________________ Fax Number: __________________________________________________________________________ Innovations in Molecular Diagnostics for Infectious Diseases (From Slideshare) Page 5/6
  • 6. Find Industry reports, Company profiles ReportLinker and Market Statistics >> Get this Report Now by email! Payment Information Please indicate the payment method, you would like to use by selecting the appropriate box. Payment by credit card Card Number: ______________________________________________ Expiry Date __________ / _________ CVV Number _____________________ Card Type (ex: Visa, Amex…) _________________________________ Payment by wire transfer Crédit Mutuel RIB : 10278 07314 00020257701 89 BIC : CMCIFR2A IBAN : FR76 1027 8073 1400 0202 5770 189 Payment by check UBIQUICK SAS 16 rue Grenette – 69002 LYON, FRANCE Customer signature:   Please note that by ordering from Reportlinker you are agreeing to our Terms and Conditions at http://www.reportlinker.com/index/terms Please fax this form to: Europe, Middle East and Africa : + 33 4 37 37 15 56 Asia, Oceania and America : + 1 (805) 617 17 93 Innovations in Molecular Diagnostics for Infectious Diseases (From Slideshare) Page 6/6