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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
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
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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
T D
ISE
AS
E D
OM
AIN
W
EL
LN
ES
S D
OM
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
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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
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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
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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
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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…
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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
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GROWING DIGITIZATION
AND
Mobile Phone Apps
TREND # 6
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COMPANION DIAGNOSTICS
The era of ‘Personalized Medicine’
TREND # 7
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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
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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”
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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
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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
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Hospitals - TODAY
LEUKEMIA
COLON
CANCER
PANCREATIC
CANCER
BREAST
CANCER
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Hospitals - TOMORROW
p 53
kras
C- kit
JAK2
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