Cell Phone-Enabled Diagnostics: mHealth Applications in IVD

August 2012 | 130 pages | ID: C66AD54DF10EN
Kalorama Information

Abstracts

Mobile health has reached in vitro diagnostics and as this Kalorama report details, may change the industry forever. Over the years, the introduction of transportable, portable, and handheld instruments has resulted in the migration of clinical lab testing from the central lab to a range of environments including self-testing, community clinics, the workplace, home, disaster care and most recently, retail convenience clinics. In spite of promotional materials that emphasize ease of use, the majority of currently available POC tests require a fair amount of medical lab know-how, especially in the interpretation of the test result.

Especially since new technologies are allowing POC devices to produce quantitative lab-quality test results that can be transferred automatically to an information system, to a remote caregiver service for consultation or to an electronic medical record.

This report, Cell Phone-Enabled Diagnostics: mHealth Applications in IVD tracks cell phone-enabled products on the market and how they will affect the existing diagnostic industry. As part of this report's coverage, the following is included:

• Representative Cell Phone-Enabled Products in Diabetes, Immunoassays, Hematology, Histology and Molecular IVD.
• Market Outlook for mHealth In IVD and The Best Areas For Commercial Success
• Description of the Market Leaders, Organizations and Companies In This Market.
• Government and Payer Support for mHealth
• The Role of New technologies in the Evolution of POCT
• Consumer, Physician and Payor Willingness
• How Upstarts are Faring Vs. Established Products
• Analyst Conclusions

Kalorama lead diagnostic analyst Shara Rosen, R.T., MBA presents the new developments in the convergence of IVD and mobile technologies in this unique overview of the mHealth IVD market. The company profile chapter provides a selection of companies and organizations that are pioneering the use of specially designed digital and or wireless and cell phone-enabled test devices for clinical diagnostic applications. The most advanced applications are available for glucose self-testing and the transmission of stained slide images in histology, microbiology and hematology for remote consultation with and analysis by an expert. The following companies are profiled.

• Accuster Technologies Pvt. Ltd.
• AgaMatrix, Inc.
• Alere
• ARKRAY
• ARUP Laboratories
• Axxin
• BBInternational
• BIO-key International, Inc.
• BodyTel Europe GmbH
• California Institute of Technology (Caltech)
• CellScope
• CellScope Inc.
• Clearbridge BioLoc Pte Ltd
• Columbia University
• DNAFORM
• eSTI – (Electronic self-testing instruments)
• Entra Health Systems
• Freescale Semiconductor
• Bill and Melinda Gates Foundation
• Gene-Z
• Genomic Health, Inc.
• GenPrime, Inc.
• Gentag Inc.
• GlySens Incorporated
• Harvard University Medical School
• Heidelberger-Medical-Marketing GmbH (HMM GmbH)
• HolGenTech Inc.
• Holomic LLC (formerly Microskia)
• Infopia Co Ltd
• Intelligent Optical Systems, Inc.
• Korea Advanced Institute of Science of Technology (KAIST)
• Labonfoil Consortium
• Leica Microsystems
• Lifescan Inc.
• Massachusetts General Hospital
• MAVAND Solutions GmbH
• MEDIWISS Analytic GmbH
• Medtronic Inc.
• MycroLab Pty Ltd.
• NextLab
• Oasis Diagnostics
• Oasis Scientific, Inc.
• QIAGEN N.V.
• QuantuMDx Group Limited
• Sano Intelligence
• Skannex
• TelCare Inc.
• Università Commerciale Luigi Bocconi
• University of Arizona
• University of Washington
• X out TB

Contents

CHAPTER ONE: EXECUTIVE SUMMARY

Introduction
Scope and Methodology
  Market Trends

CHAPTER TWO: INTRODUCTION

Background
The Case For Cell phone-Enabled Devices
Consulting From Far and Wide
Point of View

CHAPTER THREE: ENABLING TECHNOLOGIES AND COMMERCIALIZATION ARRANGEMENTS

Overview
  Definition of Cell Phone-Enabled Diagnostics
Advances in Microfluidics and Biosensors
The Interface and Communication Technologies
  UC Davis Interface
  Frontline SMS Medic
  iPhones, Blackberrys and PDAs
Are Consumers Ready for mHealth?
  Physician and Payor Opinion

CHAPTER FOUR: MARKET ANALYSIS - CELL PHONE-ENABLED DEVICES

Overview
Cell phone-Enabled Diagnostics For Diabetes
  Scourge of Diabetes
  Market Status of New Cell phone Glucose Monitors
  Regulation
  Diagnostics in Cars?
Cell phone-Enabled Rapid Immunoassays
  Decentralized Trend
  Lateral Flow Tests
  Focus on Infectious Diseases
Cell-Phone Enabled Microscopy
  Histology
  Microbiology
  Hematology
Cell Phone-Enabled Molecular Tests
  Amplification
  Nucleic Acid Lateral Flow
  Microfluidic Cartridge-Based Approaches
The Commercial Outlook for Cell phone-enabled Diagnostic Devices

CHAPTER FIVE: CONCLUSION

CHAPTER SIX: COMPANIES AND OFFERINGS

Accuster Technologies Pvt. Ltd.
AgaMatrix, Inc.
Alere
ARKRAY
ARUP Laboratories
Axxin
BBInternational
BIO-key International, Inc.
BodyTel Europe GmbH
California Institute of Technology (Caltech)
CellScope
CellScope Inc.
Clearbridge BioLoc Pte Ltd
Columbia University
DNAFORM
eSTI – (Electronic self-testing instruments)
Entra Health Systems
Freescale Semiconductor
Bill and Melinda Gates Foundation
Gene-Z
Genomic Health, Inc.
GenPrime, Inc.
Gentag Inc.
GlySens Incorporated
Harvard University Medical School
Heidelberger-Medical-Marketing GmbH (HMM GmbH)
HolGenTech Inc.
Holomic LLC (formerly Microskia)
Infopia Co Ltd
Intelligent Optical Systems, Inc.
Korea Advanced Institute of Science of Technology (KAIST)
Labonfoil Consortium
Leica Microsystems
Lifescan Inc.
Massachusetts General Hospital
MAVAND Solutions GmbH
MEDIWISS Analytic GmbH
Medtronic Inc.
MycroLab Pty Ltd.
NextLab
Oasis Diagnostics
Oasis Scientific, Inc.
QIAGEN N.V.
QuantuMDx Group Limited
Sano Intelligence
Skannex
TelCare Inc.
Università Commerciale Luigi Bocconi
University of Arizona
University of Washington
X out TB

List Of Exhibits

LIST OF EXHIBITS

CHAPTER THREE: ENABLING TECHNOLOGIES AND COMMERCIALIZATION ARRANGEMENTS
Table 3-1: Selected Cell phone Enabled Test Devices
CHAPTER FOUR: MARKET ANALYSIS - CELL PHONE-ENABLED DEVICES
Table 4-1: Selected Cell phone-based Glucose Meters
Table 4-2: Selected Wireless Enabled Glucose Monitors, 2011
Table 4-3: Rapid Immunoassay Test Sales by Test Category 2011-2016, $ million
Table 4-4: Selected Cell phone-enabled Rapid Immunoassay Innovations
Table 4-5: Selected Molecular Tests And Platforms For Infectious Diseases
Table 4-6: Selected Cell Phone-Enabled Molecular Test Devices In Development