Cell Phone-Enabled Diagnostics: mHealth Applications in IVD

  • August 2012
  • -
  • Kalorama Information
  • -
  • 130 pages

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.

The goal is for cell phone-enabled test devices to provide primary care for underserved areas in developed countries and low income developing markets. 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

Table Of 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.

  • Universita Commerciale Luigi Bocconi

  • University of Arizona

  • University of Washington

  • X out TB


andnbsp;


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

    andnbsp;



  • Table 4-2: Selected Wireless Enabled Glucose Monitors, 2011

    andnbsp;



  • Table 4-3: Rapid Immunoassay Test Sales by Test Category 2011-2016, $ million

    andnbsp;



  • Table 4-4: Selected Cell phone-enabled Rapid Immunoassay Innovations

    andnbsp;



  • Table 4-5: Selected Molecular Tests And Platforms For Infectious Diseases

    andnbsp;



  • Table 4-6: Selected Cell Phone-Enabled Molecular Test Devices In Development


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