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2020 Vision

The Future of Pathology


Jared N. Schwartz, MD, PhD
President-Elect
College of American Pathologists

APC/PRODs
Colorado Springs, CO
July 2007

1
The struggle of today, is not altogether
for today—it is for a vast future also.
Abraham Lincoln, (1809-1865)

2
Technology is transforming the delivery
of patient care

; Proactive A fundamental and


a l ized e Health
son
Per Dise ion
ven
as
t
Management significant shift in
re
Evolution of Care

Chaotic
healthcare philosophy
on
iati n
ar
V w ee
bet tyles
Flux
Medicine
and medical research
S
is occurring affecting
ic Reactive
E
a
p
t
i sod of
nt
me ms
Care treatment and early
Tre Syste
detection of disease
Time

Clinical transformation is occurring


3 Drivers for Change
The role of Anatomic Pathology is
changing

• Minimally invasive/incision-less
surgery What happens when
• Tissue characterization and imaging there is no tissue to
(virtual histology; microendoscopy)
• Molecular medicine; Tumor-specific in look at?
vivo biomarkers
• Proteomics
• Virtual colonoscopy
• Integrated information systems
• HPV and other vaccines

4 Drivers for Change


Phenotypic-Clinical
Dimension of
Pathology
Prognosis and Treatment

Diagnosis of Diagnosis of Diagnosis of Diagnosis of Diagnosis of Diagnosis of


Cervical Cancer Colorectal Lympho- Hypercoaguable Breast Cancer Gastrointestinal
Cancer proliferative State Stromal Tumors
Disorders

The Value of traditional Pathology has not


diminished. It is simply no longer sufficient.

5
Adapted from Clinical Chemistry 53 No. 7: A Case for Integrated Morphomolecular Diagnostic Pathologists, Manuel Salto-Tellez
Phenotypic-Molecular
Clinical Dimension of
Pathology
Prognosis and Treatment

Loss of
Heterozygosity Specific
Translocations 20210 A ERPR Status
Analysis
Detection of HPV Microsatellite B & T cell Analysis of
Factor V-Leiden
Infection Instability rearrange- HER2-neu Stats c-kit Mutations
Analysis ments

Diagnosis of Diagnosis of Diagnosis of Diagnosis of Diagnosis of Diagnosis of


Cervical Cancer Colorectal Lympho- Hypercoaguable Breast Cancer Gastrointestinal
Cancer proliferative State Stromal Tumors
Disorders

Type Sources
• Standalone •Molecular identification - new information
• Aggregate Panels •IT/Data Mining - new and historical information
•New identification from non-molecular sources
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Adapted from Clinical Chemistry 53 No. 7: A Case for Integrated Morphomolecular Diagnostic Pathologists, Manuel Salto-Tellez
Phenotypic-Molecular
Clinical Dimension of
Pathology
Prognosis and Treatment
Pharmacogenomics

Gene Expression Profiles

Loss of Specific
Heterozygosity Translocations 20210 V ERPR Status
Analysis
Detection of HPV Analysis of
Infection Microsatellite B & T cell Factor V-Leiden HER2-neu Stats c-kit Mutations
Instability rearrange-
Analysis ments

Diagnosis of Diagnosis of Diagnosis of Diagnosis of Diagnosis of Diagnosis of


Cervical Cancer Colorectal Lympho- Hypercoaguable Breast Cancer Gastrointestinal
Cancer proliferative State Stromal Tumors
Disorders

7
Adapted from Clinical Chemistry 53 No. 7: A Case for Integrated Morphomolecular Diagnostic Pathologists, Manuel Salto-Tellez
This isn’t Star Wars
Table of Valid Genomic Biomarkers in the Context of Approved Drug Labels
Biomarker Primary Drug Biomarker Primary Drug

C-KIT expression Imatinib mesylate G6PD Deficiency Rasburicase

CYP2C19 Variants Voriconazole G6PD Deficiency with alternate Primaquine


Context
CYP2C9 Variants Celecoxib Her2/neu Over-expression Trastuzumab

CYP2D6 Variants Atomoxetine NAT Variants Rifampin, isoniazid,


and pyrazinamide
CYP2D6 with Fluoxetine HCL Philadelphia Chromosome Bulsulfan
alternate Context deficiency
DPD Deficiency Capecitabine PML/RAR alpha gene Tretinoin
expression (Retinoic acid receptor
responder and non-responders)

EGFR expression Erlotinib Protein C deficiencies Warfarin


(hereditary or acquired)
EGFR expression Cetuximab TPMT Variants Azathioprine
with alternate Context Head & Neck Cancer
EGFR expression Cetuximab UGT1A1 Irinotecan
with alternate Context Colorectal Cancer

8 Drivers for Change


Gene expression assays are a reality

9 Drivers for Change


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11
Even the autopsy is changing!
• CT used to enhance the autopsy; pathologist and
radiologist collaborate
• May create renewed interest
– Uniform documentation of findings;
digital whole body archives
– Increased understandability; useful
information to assess injuries that routine
autopsy alone cannot
– Non-infectious procedure that does not
interfere with typical funeral/post mortem
course
– More efficient, targeted minimally-
invasive autopsy
– Less intrusive for families with religious
concerns
12 Drivers for Change
Complementary technologies improve death
determination & increase knowledge for
better medical care
Subglottic Tracheal Fluid and
Sediment

Drowning or
drug overdose?

Pulmonary ground glass opacity


13 Drivers for Change
Threat or Opportunity?

All depends on your


perspective and what
you do about it!

14 Drivers for Change


Over time, pathologists have migrated away from
the fundamental definition of the specialty
Pathology
• the scientific study of the nature of disease and its causes,
processes, development, and consequences
Pathologist
• a physician who interprets and diagnoses the changes caused by
disease in tissues and body fluids
• a doctor who specializes in medical diagnosis [syn: diagnostician]
• a specialist in pathology who practices chiefly in the laboratory as a
consultant to clinical colleagues
• a clinician who is involved in the treatment and observation of living
patients, as distinguished from one engaged in research, utilizing the
knowledge of disease as the primary tool
Source: American Heritage Dictionary; Merriam-Webster’s Medical Dictionary;
WordNet; AH Stedman’s Medical
15 Current Pathology Landscape
“Never, ever, think outside the box.”

16 Current Pathology Landscape


If pathologists don’t step up, others will
battle over the turf

Clinical care has a history of


conflict

A reluctance to train in new


technologies opens the door to
others to seize the opportunity.

Pathology is no exception
The Battle of the Barbers and Surgeons, 18th c. caricature

17 Current Pathology Landscape


Pathologists can assume the central role
in the treatment team
• What disease or irregularities
Pathologists can generate exist?
test results…or they can • Which drug should "I" (primary
provide the answers to the care provider) prescribe?
critical questions that will help • How much of the drug should I
guide the primary care prescribe?
provider with diagnosis and • Is the drug working for the
patient?
determine therapy
• Is the patient disease free? (did
it work?)

The treatment team does not know how to interpret the volume of
diagnostic data produced—pathologists are the best qualified to
bridge this gap and infuse the health care system with real value
18 2020 Vision
Pathologist Monitoring & Direction
Portion of patient

Prognosis
AP • • • CP RadRx Rx RadRx
Molecular PGx+Rx

Predisposition/
Signs/Symptoms
Diagnosis Prognosis Resolution
Entire Patient

CT/MRI/PET Physical Rx PGx+Rx Physical


• • • Molecular Intervention Intervention
Imaging

• Technology
• Data
• Organization
• Processes

19 Drivers for Change


Pathologists are physicians…
Hot Topic: The Questionable Future of the Microscope / Page 7

Modern Healthcare A Crain Communication Publication


…who take an active role in patient
THE ONLY HEALTHCARE BUSINESS NEWS WEEKLY JANUARY 6, 2020 care by utilizing available tools,
integrating and interpreting diagnostic
information to provide an accurate
diagnosis of disease, and working
Pathologists together with other members of the
take center medical team to assess prognoses
stage in patient and determine optimum therapy
alternatives.
care
CAP leads caucus on standards
development worldwide / Page 23
Disease diagnosis and treatment
determination using molecular genetics
from your local pathologist / Page 45

20 2020 Vision
Pathologists will expand their sphere of
influence using all tools and knowledge
available
• Keep current with literature/research
– Be passionate about life long learning
– Investigate emerging technologies that may improve and/or disrupt
practice
• No longer define practice as either AP or CP; expand beyond the
tissue on the slide—integrate the knowledge available
• No longer be satisfied with providing just the diagnose; expand the
value provided by influencing prognosis and treatment
• Collaborate with others providing diagnostic data and take central
role in directing the treatment team
– Integrate information into an easily understood, comprehensive patient
report; become the chief medical knowledge officer
– Seek expertise when necessary; utilize a central repository for
necessary criteria for Dx, Px and Rx guidance
21 2020 Vision
“It is not the strongest of the
species that survives, nor the
most intelligent, but the one
most responsive to change.”
Charles Darwin
English Biologist (1809-1882)

22 2020 Vision
…so, what can you do?
• Acknowledge the market forces
that are driving changes in the
practice of pathology
• Understand the implications and
embrace opportunities these
changes offer
– Engage the change by integrating
new concepts and technologies
into your programs
– Expose your residents to both the
organizational and technology
skills needed
– Don’t use the ABP certification
exam as the only guidepost—
prepare your residents for the new “I’ll be happy to give you innovative
landscape thinking. What are the guidelines?”

23 2020 Vision
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