Future of Pathology

Jared N. Schwartz, MD, PhD FCAP President, College of American Pathologists PATHOLOGY VISIONS Digital Pathology Solutions Conference October 2007 · San Diego, CA

The struggle of today, is not altogether for today —it is for a vast future also.

~ Abraham Lincoln

Technology is transforming the delivery of patient care

Reactiv e Care Chaotic Flux Medicine Proactive Health Management

Clinical transformation is occurring

Time

Why now?

Dramatic technology advancements provide new insight and the ability to answer the vital questions that drive diagnosis,

and

prognosis and therapy • What disease/condition do I have?

• Which drug should I use • How much drug do I need?

• Is the drug working?

• Is my disease gone?

And this transformation has implications for pathology

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

Digital imaging has already progressed on the technology adoption curve

High-Risk Investment

Beta and early production models available; not FDA approved

Safer Investment Market-Shaping Opportunity

Devices available & FDA approved; reimbursement not wide spread. Trials focused on patient mgmt Becoming standard of care; patient guidelines established and applied. Reimbursement established with major players

Accepted Standard

Technology Curve CAD for Pathology Genetic risk assessment Sample to answer PCR Waived CBC test HPV vaccine Gene expression Microwave tissue processors Continuous monitoring assays Screening virtual colonscopy Pharmacogenetic s for DMEs Lab automation Proteomics for cancer screening InVivo Histology Circulating tumor cell assay Intraoperative PCR Laser capture microdissection

characterization

testing

Robotic telepathology Digital imaging for path

Comparative genomic hybridization HR HPV PAP adjunct Companion Dx Color Key Positive Impact Magnitude of Impact- UNSURE Tech Curve Position- UNSURE Pyrosequencin g

0

Pre-Clinical

1

Innovators

2

Early Adopters

3

Consensus Adopters

4

Cautious Adopters

5

Late Adopters

Its impact on pathology will increase

Accelerators

• Decreased cost with ongoing product enhancement • Clinical demand for pathologist sub-specialization • Patient demand for reduced TAT for rapid, advanced diagnostics • Demand for complete EMR, including multimedia Dx data • Hospital demand for rapid TAT and value enhancement for differentiation

It is just a matter of time

Barriers

• High equipment costs and work flow change • Parallel technology developments • Automation • Image acquisition • Standards agreements • Data storage • Communication and clinical applications 40-sec 20x scan 20-sec 20x scan 20-second 40x multi-angle scan Multispectral imaging Rapid secondary consultations Computer-aided detection Subspecialist work flow triage Computer-aided diagnosis 100 Terabytes Petabytes 100 Petabytes Enterprise image management Pathology PACS

2007 2012 2017

* Source: Sg2 T3 Virtual Slide Imaging

Each pathologist and organization has a place on the Tech Curve

Consensus Adopters — Early Adopters —target Innovators —target Cautious Adopters —Target Where is the specialty of pathology?

Late Adopters —

“Never, ever, think outside the box.”

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

The Battle of the Barbers and Surgeons, 18th c. caricature 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

Reluctance to train in new technologies opens the door to others to seize the opportunity Main Topic at ACR’s 2007 Forum Leadership in Radiology

…Forum attendees worked to pinpoint ways in which the ACR and its partners can better identify, cultivate, and empower a new generation of radiology leaders in these increasingly turbulent times…

Could it happen?

ABR Board exams address pathology

Diagnostic radiology now encompasses a variety of diagnostic and image guided therapeutic techniques, including all aspects of radiological diagnosis, nuclear radiology, …molecular diagnostics and morphology… Integrating pathologic assessment into your radiology reports requires effective management of pathology technicians and adequate quality control. New Board exams address the technical and management skills needed.

Myths and rumors about the future may be inhibiting action

• Pathology is merging with radiology • There is too much to learn; I don’t have time • Emerging technologies won’t impact my practice • Besides nobody will pay for it • We are turning into dinosaurs • Etc., etc. etc…

Opportunity exists for pathologists that are ready “Opportunity paged me, beeped me, linked me, emailed me, faxed me, and spammed me. But I was expecting it to knock!”

Traditional Pathology Prognosis & Treatment Imaging Gene Expression Pharmacogenomics Biomarkers The value of traditional pathology has not diminished. It is simply no longer sufficient.

Predisposition, Signs, Symptoms

Pathologists can generate test results…

OR

provide answers that guide the treatment team with diagnosis and therapy

Pathologists are physicians

…

…take an active role in patient care, utilizing all available tools to integrate and interpret diagnostic information to provide an accurate diagnosis of disease. Pathologists work closely with other members of the medical team to assess the patient condition and prognosis in order to determine optimum therapy alternatives.

Pathologists are not defined by the tools they use, but the knowledge they share

…so, what can you do?

• Acknowledge market forces driving changes in practice of pathology • Re-assess your tool kit—all diagnostic tools are available to you • Engage the change— integrate new concepts and technologies • Be life long learners; don’t use the certification exam as the guidepost • Expand beyond the tissue on the slide “I’ll be happy to give you innovative thinking. What are the guidelines?”

So, what’s it going to take?

Get back to being a physician!

“It is not the strongest of the species that survives, nor the most intelligent, but the one most responsive to change.” ~ Charles Darwin