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EMERGING TRENDS IN

DIAGNOSTICS

(Hony) Brig. Dr. Arvind Lal

Padma Shri

Chairman & Managing Director

Hony. Physician to the President of India

1

Setting the Stage …….

Many trends relate to the technological advances & the

necessity to increase quality & efficiency

New factor for IVD industry, not previously seen, is the

influence of educated & informed healthcare consumers

Clinical lab testing is one of the greatest bargains in

healthcare but often draws the attention from cost-cutters

Lab professionals also will increasingly capitalize on these

emerging opportunities & options

3

Indian Healthcare Industry..

Healthcare industry - ~$300 billion by 2020

Growth Drivers Demographic shifts

Growing per capita incomes/ literacy

levels

Healthcare awareness – demand for

quality / reliable services

? Increase in Government Spending -

12th five year plan - 2.5% of GDP by

2017

Penetration of Life and Health

Insurance

Changing Lifestyles – incidence of

NCDs

Medical tourism

Tax benefits/Insurance Coverage

4

Diagnostics: Epicenter for innovation and disruptive

technologies

Laboratory represents

only a small fraction of

total hospital costs <5%

Laboratory results are responsible for

70% of all clinical decisions

5

Diagnostics – Growth Drivers

Changing nature of disease

Changing care delivery models

From treating sickness to

promoting wellness

Home monitoring

New medical technologies &

genomics

Personalized medicine by

Molecular diagnostics

Research and Development / clinical

trials

Healthcare awareness – demand for

quality / reliable services

6

WELLNESS HEALTH MODEL

Power of diagnostics to change the focus of

healthcare from treating sickness to promoting

wellness.

TREND # 1

7

ILLNESS TO WELLNESS The move to total population health management

Care Management is moving to the left

Well At Risk ILL Chronically

ILL

Acutely

ILL

20%

of population

80%

of population

150+ Million Covered Lives

Managing Costs Reversing the Trend

8

State of Wellness

(Absence of Diagnosable Disease)

Preventive

Medicine,

Predictive Medicine,

Genomic

Medicine/

Predisposition

to Disease

State of Diagnosable Acute Disease

(Short-Term, Self-Limiting)

State of Chronic Diagnosable Disease

(Long Duration and/or

Frequent Recurrence)

Diagnostics

pushing in

this direction

OV

ER

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ISE

AS

E D

OM

AIN

W

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LN

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AIN

EA

RL

Y H

EA

LT

H D

OM

AIN

9

RISE OF THE CORPORATION

Consolidation & Automation

TREND # 2

10

Industry recognizes the opportunity ………….

Are diagnostics the

new wonder drug

on Wall Street?

11

Diagnostic tests are the critical links to the

success of “Healthcare for all”

• Only 15-17% of pathology testing is done by Organized laboratories.

• Bringing quality testing into Tier III/1V towns will be key to delivery

of healthcare and prevention of non-communicable diseases

12

• Hub and spoke model – for delivery and

penetration into the rural areas

• Pre-analytical quality assurance for offsetting

70% of diagnostic errors is paramount for

quality diagnostics

Pathology Lab Network

-Sample Collection moving closer to patient

- Testing done at a central location

1980 - 2000

Lab

CC1

CC3

CC4

CC2

BIRTH OF HUB & SPOKE MODEL

LAB 1

cc1

cc3

cc4

cc2

LAB 2

cc1

cc3

cc4

cc2 LAB

3

cc1

cc3

cc4

cc2

CENTRAL

LAB Mumbai

Delhi

Kolkata Bangalore

Post 2000: National Pathology Grid

Delhi

Metro

Mini Metro

Other towns

Types of Units

-Reference Lab

-Metro Lab -Satellite

Lab -Collection Centers

Product Protfolio - 1850 Tests

- 500 Tests

- 300 Tests

- App. ALL

Activity - High End Testing - High End & Routine

Testing

- Routine Testing

- Sample Collection

Business Model

AGARTALA NEW DELHI

Location of Server

REMOTE LAB

Frankston

2800 km 2 X 128K

ISDN

REMOTE LAB

REMOTE LAB

REMOTE LAB

Hospital with Lab prop. interface

Hospital with HL7 Interface

REMOTE LAB

REMOTE LAB

REMOTE LAB

Dr Lal PathLabs ICT NATIONAL PATHOLOGY GRID

Remote Lab Hospital with Lab Collection Centre Dr.'s PC

Collection Center

Collection Center

Collection Center

Collection Center

Collection Center

Doctor’s PC

Doctor’s PC

INSAT-3C enabled

bi-directional interface

Role of PPP in Rural Healthcare

TREND # 3

18

Public Sector: • Infrastructure: Utilization Public Health Facilities

• Manpower: Use of healthcare workers from rural centres

• Patient Volume

Private Sector: • Private Investment

• Knowledge & Technological capabilities

• Systems & Processes

• Checks & Balances for accountability of service delivery to patients

•State governments are responsible for healthcare providing 80% of public

funding. The Central government contributes only15%, mostly through national

health programs

• Private sector account for 82% of India’s expenditure on healthcare. In

comparison to 27% for the G7 countries (Canada, France, Germany, Italy,

Japan, the United Kingdom, and the United States)

•Private firms are now thought to provide about 60% of all outpatient care in

India and as much as 40% of all in-patient care

•It is estimated that nearly 70% of all hospitals and 40% of hospital beds in the

country are in the private sector

Current healthcare spending in India….

PPP - Hub & Spoke Model

CENTRAL

LABORATORY

DH

CHC

CHC

PHC

DH PHC

CHC

PHC DH DH

CHC

PHC

Sample Transportation Box

Assuring quality of samples

SterileTube

Exact amount of

anticoagulant

Vacuum controlled

draw

Color code Security valve

Laser needle

sharp

Holder

Closed system

Vacutainer: vacuum phlebotomy system

Need for Accreditation

Quality of samples and testing

TREND # 4

25

Laboratory Accreditation …. WHY?

•Recognition Increases the confidence in testing Laboratories

•Facilitates the acceptance of tests results

26

Current Indian Scenario?

27

Diagnostic Industry

Organizedsector

Unorganizedsector

< 1% Labs are accredited

29

Laboratory errors cost in….

time

personnel

effort

30

• Detects errors timely and thus ensure speedy

management and treatment of the patient

• Only 800 labs are currently accredited by NABL!

Quality Management in Laboratories

CONSUMER CENTRIC HEALTHCARE

Handheld devices

and

POC (Point of Care) testing

TREND # 5

33

POC Can Now Be Anywhere…

POC is defined as - Care at the bedside & anywhere else the patient might be; or where decisions are made by a caregiver, wherever they may be

POC with Wireless networks and mobile hardware shall provide clinicians with real time patient data

Instead of clinicians going where data is, data is now going where the clinician is…

34

POCT is Not Just for Glucose!

Glucose

Coagulation

Blood Gas

Chemistry

Hematology

Urinalysis

Cardiac Source: Enterprise Analysis Corp.

Stamford, CT

1999 (510 Hospitals)

2001 (584 Hospitals)

% of Hospitals with POC Devices by Discipline

51%

62%

34%

50%

14%

36%

18%

28%

5%

15%

1%

3%

98%

99%

35

What’s Driving POC testing?

Greatest need in emergencies- Fastest test results for critically ill patients

Home monitoring- diabetes, pregnancy etc

More tests are being added, ultimately

reducing overall healthcare costs – yet

to impact India

36

GROWING DIGITIZATION

AND

Mobile Phone Apps

TREND # 6

38

39

COMPANION DIAGNOSTICS

The era of ‘Personalized Medicine’

TREND # 7

43

How diagnostics can change the future of healthcare?

Ongoing monitoring of genome that will

ultimately lead to personalised medicine, early

diagnosis of genetic diseases and genetic

engineering

Even cancers have got a novel genetic signature by

altering the normal genome through mutation

Emerging treatment options based on new

medical discoveries & new drugs coming to the

market

44

One size fits all ?…… Approach to therapy Pharmacogenetic (PGx) diagnostics

are gene-based diagnostic tests used

to determine individual benefits or

harms of taking certain medications

One such use of PGx links individual

genetic variation to information on

drug metabolism (drug breakdown

and processing in the body)

Shift within the medical community

from a “one size fits all” drug

treatment approach to that of “right

amount of the right drug for the right

patient”

45

Personalized Medicine Test Categories … some

examples Disease Condition Drug Selection Lab Test

Breast Cancer Herceptin® HER2

Drug Dosage

Colorectal Cancer Erbitux KRAS

Drug Efficacy

Chronic Myelogenous Leukemia Gleevec® Quant BCR-ABL

Disease Status

Chronic Lymphocytic Leukemia Campath® Minimal Residual Disease

Recurrence Risk

Breast Cancer Oncotype DX® BRACA 1 & 2

Predisposition

Breast Cancer BRACAnalysis® Gene sequencing, risk

analysis

46

Kras gene positivity eliminates the need for Chemotherapy

in Colon Cancer

When kras test is used to decide whether to treat with

Erbitux in colon cancer patients …. Thus…

• 40% of patients spared side effects from ineffective

treatment

• 60% reduction in cost per success

Langreth, R. (2008), ‘Imclone’s Gene Test Battle’, Forbes.com, 16May

47

Hospitals - TODAY

LEUKEMIA

COLON

CANCER

PANCREATIC

CANCER

BREAST

CANCER

48

Hospitals - TOMORROW

p 53

kras

C- kit

JAK2

49

arvind.lal@lalpathlabs.com

Thank You

50