1. New Developments in
Point-of-Care (POC)
Diagnostics
POC Biochips and device connectivity are among the new trends in point of care
Diagnostics covered in this white paper, based on information from Kalorama
Information’s latest report on the testing market, The World Market for Point of
Care Testing.
POC Biosensors
Molecular diagnostics and extremely sensitive next-generation immunoassays are
now available for POC testing and physician office laboratories through the
development of microfluidics and biosensors. Biosensor technology use substrates, nanomaterials and
advanced spectroscopic or electromagnetic wavelength analysis methods to perform extremely sensitive
testing on a small platform that signals results through an electronic digital system. Industry leveraging of
biosensor and microfluidics technologies has been diverse with manifold products available on the market
and in development.
These unique test formats are very applicable to POC testing as they eliminate the requirement for
multi-step assay preparation and extensive or complex reagent and or wet chemistry handling.
Microfluidics technology has made the transition from research into the commercialized IVD space
through the use of multichannel and multiplex cartridges, cassettes and
cards. These self-contained, largely disposable, assays can be run alone or in
conjunction with an analyzer that determines results through a luminescent,
fluorescent or chromatographic result that is digitized. A common feature of
such prototypes and products is the miniaturization of clinical lab
capabilities onto new assay forms.
Products enabled by biosensors or microfluidics are intended to produce
lab quality results outside of the laboratory and to be used by relatively
untrained operators. Competition between numerous molecular POC platform providers and developers
may factor significantly into future POC markets. Currently, molecular POC systems are targeted
primarily for hospital markets and POC markets in developing regions.
Based on Information from
Kalorama Information's
The World Market for
Point of Care Diagnostics
http://www.kaloramainform
ation.com/Point-Care-POC-
9030928/

2. Selected Biochip and Biosensor Players
Company/ Organization Location Target Details
Acrongenomics Inc. Switzerland creatinine BioLED Lab on a Chip; urine creatinine
Ativa Medical U.S. various Analyzer and microfluidics test card systems
Biocartis Switzerland various Molecular Diagnostics Platform and Multiplex
Detection Platforms (immunodiagnostic)
Biomagnetics Diagnostics U.S. / China inf dis Integrity Optical Biosensor (IOBS); infectious
diseases
Biosensia Ltd. Ireland various RapiPlex microfluidics immunoassay instrument
and test card system with multiplexing capability
Diagnostics for All U.S. inf dis Paper-based microfluidics card; infectious diseases
in developing world
EKF Diagnostics GmbH Germany glucose / lactate BIOSEN instrument chips for enzymatic detection
and quantification of glucose and lactate
Gentag Inc. U.S. various Printable biosensors on adhesive battery-less RFID
skin patch for glucose monitoring, other patient
monitoring parameters, pathogen and cancer
marker detection
Great Basin Corporation U.S. inf dis Company platform combines isothermal
amplification with chip-based detection
Hai Kang Life Corp. Hong Kong multiplex
molecular
EFADchip using electric field-assisted
hybridization
Innovative Biosensors U.S. inf dis Immunodiagnostic technologies and biosensor
components for infectious disease testing,
including HAIs
Micronics (Sony
Corporation)
U.S. blood type / inf
dis
Laminar flow diffusion cards for rapid blood
typing products and analyzer system for rapid
molecular detection of infectious pathogens
Philips Handheld
Immunoassays
Netherlands cardiac /
emergency
Magnotech technology uses magnetic fields to
wash away analyte-unbound magnetic
nanoparticles and quantify remaining analytes;
cardiac markers
Q-linea Sweden inf dis Amplified Single Molecule Detection (ASMD)
recognition and microfluidics analysis system for
targeting nucleic acids and proteins
QuantuMDx Group U.K. inf dis
cancer markers
Diagnostic and sequencing bio-chips; developing a
microfluidic solution for nucleic acid extraction,
nanowire-based biosensor, genomic sequencing
biosensor, and thermal reactor (amplification)
based on microfluidic channels; Q-POC cartridge-
based POC analyzer
Rhenoix U.S. inf dis
companion
POC molecular analyzer and self-contained,
microfluidics all-in-one molecular cartridges
Sentinel Bioactive
Paper Network
Canada inf dis Paper-based immunochromatographic sensors
Veredus Laboratories Singapore influenza VereID Biosystem, PCR lab-on-a-chip
VeriTeQ Corporation U.S. glucose Implantable RFID glucose monitoring biochip
acquired from PositiveID Corporation
Source: Kalorama Information

3. Microfluidics technology has been widely implemented in molecular multiplex assays and in many
nascent alternative format immunoassays. Biosensors generally have failed to live up to previous
expectations of a +$1 billion clinical and applied diagnostics market (with the exception of the common
glucose meter), but continue to draw interest in the form of academic research and start-ups.
Commercialized and cleared biosensors would find ready application in the POC setting due to small
system footprint, the elimination of user interpretation (biosensor design implies a digitized result), and
flexible throughput (disposable assay through small benchtop systems).
Beyond molecular POC systems (primarily for infectious diseases), biosensor- and microfluidics-
enabled systems and assays will represent nascent or niche markets for POC testing.
POC Connectivity
Connectivity in POC testing has transcended the interface between device and user or computer to
support the integration of POC and POL testing results in greater laboratory information and health
information systems (LIS/HIS). Healthcare consolidation has intensified demand for data and results
availability from POC testing on organization systems that can be shared among clinics, hospitals, and
affiliated laboratories. Suppliers of POC testing products and third-party vendors have appropriately
standardized POC instrument-desktop/laptop computer connectivity, complete with data management
software or features, and have developed solutions for data conversion and availability on same-party and
third-party information systems. Continued consolidation in healthcare systems and mounting pressure to
coordinate care and eliminate unnecessary repeat services will encourage greater penetration of
connectivity solutions among POC instruments and devices.
Device connectivity with office, practice or clinic computers is easily accomplished with device
manufacturer data management software. Device data and test results can be downloaded or uploaded to a
POC device through wireless connection, USB port, docking station, or ancillary device. Data
compatibility and standards are more easily achieved in device-computer interfaces and closed systems,
allowing a specialty clinic or practice to streamline test volumes from one
device – whether hematology analyzer, coagulation analyzer, or
immunoanalyzer.
The true challenge and increasingly evident imperative for POC
suppliers is the interconnection of POC test devices through an interface
with laboratory information systems (LIS). Largely absent standards for
POC test data run afoul of quality assurance (QA)/quality control (QC)
requirements and efficient user or operator data management. In a study by
Kalorama Information, only 4 out of 17 major LIS vendors offered systems with POC interface
capabilities. The POC-LIS interface will be the chief focus of development as POC test data integration
with organization LISs will in turn ensure the inclusion of POC test results in patient electronic records on
Based on Information from
Kalorama Information's
The World Market for
Point of Care Diagnostics
http://www.kaloramainform
ation.com/Point-Care-POC-
9030928/

4. HISs and electronic medical records (EMRs). While physician offices and practices have not seen EMR
penetration on the scale of hospitals and inpatient care facilities, the associated market is expected to see
the highest growth in the short term as EMR vendors seek out growth by downscaling products or remote
hosting systems to make investment more amenable to smaller clients. With the penetration of EMR into
the physician office market, POC tests will also require POC test device interfaces – whether direct or
indirect – with electronic patient records.
Middleware has also emerged as a solution to the development of POCT-LIS/EMR interfaces.
Middleware vendor TELCOR’s QML system architecture uses its population of device-specific drivers to
reformat data for upload and download between POC test devices and health systems. TELCOR
middleware for POC connectivity is available for the following POC devices:
• Abaxis Piccolo Xpress
• Abbott Diagnostics CELL-DYN Emerald and 1800; Abbott Point of Care i-STAT; Abbott
Diabetes Care glucose meters
• Accriva Diagnostics VerifyNow, Hemocron Signature, and Hemocron Response
• Alere Afinion and Triage
• Beckman Coulter Ac·T
• Bio-Rad Laboratories in2it (II)
• Helena Laboratories Cascade POC and ICHOR II
• HemoCue (Radiometer) 201DM, B-Hg, and Glucose
• Horiba ABX Micros 60 and Pentra 60C+
• Instrumentation Laboratory GEM PCL Plus
• Quidel Sofia
• Roche Diagnostics CoaguChek XS Plus, CoaguChek XS Pro, and Urisys 1100
• Sysmex pocH-100i
Additional connectivity solutions are available through manufacturers such as Abbott (i-STAT
instrument dock for download and POC data manager software; integration possible through Abbott,
Alere, RALS and TELCOR architectures), Alere (Afinion optional data connectivity converter
component; Triage Census ATM system for upload/download capability); Roche Diagnostics
(CoaguChek ancillary device for wireless transmission of device data and upload onto connected
computer); and Abaxis (data manager software able to connect to up to 8 Piccolo Xpress instruments).
Many benchtop analyzers feature connectivity features as product extensions of core lab instruments.
Additionally, a subset of lab instruments and analyzers are able to connect HL7 data transfer directly
to an EMR system, eliminating the requirement for interfaces or additional systems.

5. The World Market for Point of
Care (POC) Diagnostics
The World Market for Point of Care (POC) Diagnostics presents
the most current and authoritative analysis of the POC diagnostics
industry and the role it plays in medical practice. This report takes
an in-depth look at the POC diagnostic testing market, both
professional and self-testing. The report provides exclusive market
sizing and growth projections for the following POC market
segments:
• Blood Glucose Tests
• Blood and Electrolytes Testing Market
• Rapid Coagulation
• Rapid Cardiac Markers
• Substance Abuse Testing
• Pregnancy and Fertility Testing
• Colon Cancer Screening/Fecal Occult Blood Testing
• Infectious Disease Testing
• Cholesterol Testing
• Cancer Testing
• Urine Strip Testing
• Miscellaneous POC Testing
Who are the top companies in the market? What types of point of care testing is selling fastest? What
disease areas will drive near-patient forward? Is POC earning its place in clinical practice? How is home
testing progressing? These questions and more are addressed in Kalorama
Information’s report. Past editions of the report have long been used by top
point of care test makers to conduct business planning.
The report’s geographic scope is worldwide with information for specific
geographical regions, world demographics, and other general issues
affecting the market. All market data pertain to the world market at the
manufacturers’ level. The market includes manufacturer tests excluding
services. The base year for data is 2014.
Historical data is provided for the years 2012 and 2014, with forecast data
provided for 2014 through 2019. Compound annual growth rates (CAGRs)
are provided for 2014-2019 periods for each segment covered. Competitive
analysis is provided for the year 2014.

6. Market analysis of the global POC testing market includes:
• Market Overview
• Market Analysis by Product Categories
• Market Analysis by Subcategory: POC Professional Testing, POC Self-Testing
• Market Analysis by Country: United States, Germany, France, UK, Switzerland, Japan,
China, India
• Market Conclusions
• Competitive Analysis
• Trend-Reimbursement Challenges
• Trend-Competition
• Trend-POC and Biosensors
• Trend-POC Connectivity
• Trend-The Emergence of Non-invasive Technologies
Among the top and/or innovative competitors discussed within the report's
Corporate Profiles:
• Abaxis
• Abbott Labs
• Accriva
• ACON
• Alere
• Arkray
• Beckman Coulter
• bioMerieux
• Church & Dwight
• Eiken Chemical
• EKF Diagnostics
• Enterix
• Helena Labs
• Insight Pharmaceutical
• Instrumentation Laboratories
• LifeScan
• Macherey-Nagel
• Meridian BioScience
• Nova Biomedical
• OPKO Health
• OraSure
• Ortho Clinical Diagnostics
• Polymed Therapeutics
• Polymer Technologies
• Quidel
• Radiometer Medical
• Response Biomedical
• Roche Diagnostics
• Siemens Healthcare
• Sysmex
• Trinity Biotech
FOR MORE INFORMATION OR TO ORDER
http://www.kaloramainformation.com/Point-Care-POC-9030928/