Could POCT’s be a business opportunity?

Presented by Inma Uzkudun

Madrid, 30th of April 2010

0MONDRAGON Health

Point-of-Care Testing (POCT)

Market of POCT’s

What clinicians think of POCT’s?

Trends & Forecasts

Conclusions

INDEX

1MONDRAGON Health

MONDRAGON CORPORATION

New Business Development Centre

MONDRAGON Health

4

MONDRAGON Corporation

In millions of Euros (2008)

Finance Area (Caja Laboral

Customers Credits): 13,988

Industry Area: 6,511

Distribution Area: 9,073

Personnel (2008)

Total Employment: 92,773

Employment Abroad: 14,938

Alemania (3)

Rep. Checa (7)

Tailandia (1)

India

Marruecos(2)

Francia (5)

Brasil (6)

Brasil

Mexico (7)

Mexico

Polonia (7)

China

China (9)

U.S.A.

U.K.(3)

India(1)

Italia(4)

Rumania (2)

Rusia

Turquía(2)

Sudáfrica (1)

Eslovaquia (2)U.S.A.(1)Portugal(2)

FINANCEAREA

INDUSTRY AREA

Industrial Automation Division

Automotive Division

Bodywork and Supplies Division

Components Division

División Equipamiento

Household Division

Engineering & Services Division

MONDRAGON

Tooling & Systems Division

Vertical Transport Division

Machine Tools Division

Industrial Systems Division

Knowledge Area

Construction Division

New Business Development Centre

Manufacturing Subsidiaries (69)

Corporate Delegations (6)

5

MONDRAGON New Business Development Centre

Respond to the challenge of generating employment, preferably of a co-operative nature, in our community with the need seen to strengthen, amongst other things, our commitment to development which necessarily means Innovation and New Business Development.

NEW BUSINESS DEVELOPMENT CENTREInstrument

“Job creation, preferably of a cooperative nature and in line with the ongoing development of our community”

Corporate Challenge:

6

MONDRAGON New Business Development Centre

New Business Development

Centre

MondragonEnergy

Mondragon Health

Strategic Areas

7

MONDRAGON Health – Current Projects

MONDRAGON Health

Telemedicine

ICT

Profesional Health Training

Integral Solutions

Clinical DiagnosisDistribution

Automation / Robotics

Multimedia

Elderly Care Services

2Point-of-Care Testing (POCT)

Definition

Main goal

Advantages & Disadvantages

Types of POCT’s

Where can we find POCT’s?

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Point-of-care testing definition

The College of American Pathologists (CAP) defines point-of-care testing (POCT) as testing that does not require dedicated, permanent equipment space. That is, tests are performed with devices brought to the bedside or other patient locations such as the operating room (OR).

The Clinical Laboratory Improvement Amendment (CLIA) mirrors the CAP definition but further limits the tests and devices to those where the results are used for clinical decision-making.(Dondelinger, R. – 2009)

POCT is also defined as “any test taken by or on behalf of the treating doctor on-site at the time of consultation, which allows the test result to be used to make immediate decisions about patient treatment”(Laurence, C. et al. 2010)

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The goal of POCT’s and its main advantages and disadvantages

Point-of-care testing was developed to generate quicker results. The goal of POCT is to provide the clinician with rapid results, which can improve patient outcomes and quickly supply therapeutic interventions as compared to those results obtained from the core laboratory.(Sautter, R and Lipford, E. – 2007)

• Generates quicker results• There are easy to use devices• Enhance patient-convenience • Eliminates specimen transportation• Contributes to rapid diagnosis• Minimally invasive

ADVANTAGES

• Quality loss• Overpriced tests• Non-qualified staff reading the results• Multiplication of tests in order to avoid

possible errors• Not appropriate for all testing • Record of results

DISADVANTAGES

MA

IN

GO

AL

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Types of POCT’s

Biochemistry

• Glucose Testing• Blood Gas and

Electrolytes • Rapid Cardiac Markers• Drugs of Abuse• Urine Strips• Pregnancy Test• Fecal Occult Blood• Cholesterol• Infant Jaundice• Rupture of Fetal

Membranes (ROM)• Typhoid

MicrobiologyImmunology

•Infectious Disease•HIV•Anthrax•C.difficile•Dengue Fever•Malaria•Influenza•Streptococcus

•Food Pathogens

Haematology

• Rapid Coagulation Marker

• Haemoglobin Testing

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Where can we find POCT’s?

Home

Primary Care

Hospital

Disaster Areas

Pharmacies (Over the Counter)

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Home

Nowadays, the most commonly used are gloucometer and coagulometer

Significant growth is expected in the years coming

It is believe that other POCT devices such us those measuring cholesterol, creatinine, and urea could be used at home for self-monitoring in chronic patients

The trend at home would be to joint illness monitorization with analite test making

Attention process tend to simplification

It would be important to be able to send the information read at home to the electronic medical record of the patient

Chronic illness diagnosed Analite in POCTs

monitorization

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Primary Care

Resistance to POCT expansion in primary care due to a loss of control feeling in traditional disciplines

Nowadays, POCTs in primary care are not commonly used except for little use of coagulometers, glucometers and infectious diseases (streptococcus group A, influenza...)

The growth model would be general clinical analysis based on POCT devices that are able to perform, in a simple way, the most basic information for a presumption diagnostic

In Infectious Pathology specific kits would be developed for different etiologies such as CMV, mononucleosis, rotavirus...

Future systems in medical management with an stronger weight in self-management would boost the development POCT devices

It would be advantageous to use POCTs to have immediate access to data through patient electronic medical records

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Hospital

CRITICAL CARE UNITSBiochemistry, Haematology and

Infectious DiseasesPatient monitoring

OPERATING ROOMSBiochemistry, Haematology and

Coagulation Monitoring during operation

HOSPITALIZATION/SURGERIESBiochemistry, Haematology and

Infectious DiseasesAnalysis usually sent to central

laboratories

EMERGENCY ROOMSBiochemistry, Haematology and

Infectious DiseasesDiagnostic acute illness

HOSPITAL’S CENTRAL LABSome POCTs would be used at central labs if there is an small

number of tests to be done and if they are in validation process

ICT Integration

ICT Integration

ICT

integration

ICT

integration

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Disaster areas

Use of POCT in disaster and emergency situations will efficiently facilitate rapid evidence-based diagnosis at the site of patient care

POCTs are very easy to use and don’t require a previous installation

They are very easy to maintain

Easy to use devices perfect to be used also by nurses

A variety of tests are currently available for POCT in hospitals, but the spectrum of POC tests for emergency and disaster care must be broadened

In disaster areas a diagnostic with a minimum of security requires a radiologic test as well as biochemical and hematologic. POCTs facilitate the last two.

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Pharmacies (Over the Counter)

It could be an extension of home usage but more occasional and subject to market demand It allows people to remain anonymous in comparison with other types of assistance

Pharmacies are open 24/7 and are easy to access

3Market of POCT’s

POCTs revenues and worldwide distribution

Largest Companies and Segments of POCT

How do we see the market?

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POCTs revenues and worldwide distribution

GLOBAL POCT REVENUES (2005-2012)

YEAR REVENUES ($ BILLIONS)

2005 4.96

2006 5.50

2007 6.20

2008 6.66

2009 7.15

2010 7.66

2011 8.23

2012 8.83

WORLDWIDE DISTRIBUTION OF POCT (2008)

SECTOR SALES($ MILLIONS) SHARE (%)

Europe 3.254 49

U.S.A. 2.363 36

Japan 475 7

China 194 3

India 139 2

ROW 234 3

TOTAL 6.659 100

Source: Biotechnology Associates

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Largest Companies and Segments of POCT

LARGEST POCT DIAGNOSTIC COMPANIES

WORLDWIDE (2007)

COMPANY MARKET SHARE(%)

Roche Diagnostics

15

Inverness 8

Siemens (Medical Solutions)

8

Abbott Diagnostics

6

Instrumentation Lab

5

Source: Biotechnology Associates

WORLDWIDE POCT DIAGNOSTIC & RAPID TEST MARKET SEGMENTS (2007)

SEGMENT SALES($ MILLIONS)

GROWTH RATE(%)

PERCENTAGE DE POCT (%)

Blood Glucose Monitoring 1.425 4 23

Critical Care 929 <5 15

Rapid Cardiac Markers 496 15 8

Infectious Disease 434 5-7 7

Fecal Occult Blood 372 <5 6

Cholesterol 310 >10 5

Coagulation 372 5-7 6

Urinalysis 248 <5 4

HIV 186 <5 3

Pregnancy Test 186 <5 3

HbA1c 186 >10 3

Haemoglobin 124 5-7 2

Rapid Drugs of Abuse 62 <5 1

Other Miscellaneous Tests 866 >10 14

TOTAL 6.196 7 100

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How do we see the market?

The market of POCT devices seems to be very promising

Culturally people pursuit the idea of quickness

Technologically fast-growing market

POCTs are specially relevant within the private sector

One interesting market is going to be developing countries such as China, India or Brasil.

4What clinicians think of POCT’s?

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Questionnaire outcomes I

1.) Do you use POCT devices at your hospital?- Quickness of results - Rapid diagnosis- Reliability of results- Easy to perform tests

YES

2.) Main reasons of usage- Generates quicker results- There are easy to use devices- Enhance patient-convenience - Eliminates specimen transportation- Contributes to rapid diagnosis

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Questionnaire outcomes II

3.) Where in your hospital do you use POCTs?- Central Lab- Operating Rooms- Emergency Rooms- Hospitalization - Other

4.) What would you like to measure with a POCT device?PCR, Procalcitonin, MRSA, Hemogram

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Questionnaire outcomes III

5.) Mark with and X the following POCT manufacturers that you know?- Roche Diagnostics- Inverness- Siemens (Medical Solutions)- Abbott Diagnostics- Bayer Healthcare- Other

6.) Do you think the use of POCTs would keep growing? If so, why?- Useful to take rapid decisions

- Easy to use- Cost-efficient devices- Better quality through time - Convenient

YES

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Questionnaire outcomes IV

7.) In your opinion the use of POCT devices clashes with the analysis done in central laboratories ?

- It complements central laboratories- The use of central labs is still needed - POCTs are for specific things - Central Labs perform tests in more depth

NO

5Trends & Forecasts

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POCT’s trends & forecasts

• Increase awareness of personal health could boost over the counter sales

• More tests would be available as portable devices, to facilitate home use

• Loss of market control by central laboratories, mainly due to cost cuts in public sector

• Technical improvements would allow POCT devices to broad menu and process a greater number of tests

• Greater relevance of nurses which could have an allied in POCT technology

It is believe that by 2012, nearly 50% of all clinical diagnostic testing will be done by point of care devices.

6Conclusions

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Conclusions

Optimistic forecast for POCT market

New technology developments

Value of immediate results and easy to use devices

According to professionals POCTs are useful and it would keep growing

Central Lab doesn’t clash with POCT technology

Use especially indicated for chronic patient monitoring

POCTs should be able to communicate with patient’s electronic health records

Clinicians should collaborate with POCT manufactures in order to request the required parameters for them

Thank you!