Kenneth J. Bloom, MD, FCAP Chief Medical Officer, Clarient, Inc. Clinical Professor of Pathology, USC Establishing a Real-Time Consultative Network: The CLARiENT Experience

My Experience with Telepathology/Virtual Pathology  Performing virtual pathology since 1985  Commercialized first virtual pathology system in a reference laboratory setting  Currently supporting over 700 pathology practices using utilizing various aspects of virtual services.  I review approximately 90% of my cases virtually  I have a consultative network of virtual pathologists to help me in my practice.  I have implemented about 40 virtual microscopy systems

The Evolution of Virtual Pathology in a Reference Setting - Basic Business Strategy Strategies based on disruptive innovations have the highest chance of creating growth. Introduce benefits such as Simplicity Convenience Ease of use Lower price Clayton M. Christensen, The Innovator’s Dilemma

The Disruptive Playbook Scratch an unscratched itch Make it easier to get an important job done Make an ugly business attractive Find a way to prosper at the low end of established markets by providing a good enough solution at low prices Democratize a limited market Expand the market by removing barriers such as lack of skills or access

Implementing a playbook Make it easier to get an important job done Quantitative assessment Find rare events Obtain measurements easily Simplify and improve access to second opinions Make an ugly business attractive Reduce Fed’Ex costs Democratize a limited market Allow access to complex/difficult immunostains Eliminate the need for clients to obtain space, people and equipment

Manpower/Resource implications Shortage of qualified histotechnologists Shortage of subspecialty Expertise Need for high priced equipment without adequate volume Lack of space Competing resources More residents being trained in advanced technology but those technologies not available to them in the job market

What problem am I trying to solve?  Reduce logistical costs  Improve turn-around time  Reduce workforce requirements  Allow clients 24/7 operations  Empower local pathologists  Access to expertise  Access to new technologies  Access to more complete menu  Access to Information Technology

IHC Biomarker Ordered Block Pulled & Slides Sectioned IHC Stain Performed Slides Collated & Delivered To Pathologist Pathologist Review & Interpretation Take pictures Sign Out Report Traditional Clinical IHC Workflow

Virtual Microscopy Workflow Virtual Microscopy Pathologist Review & Interpretation Off-Site Review Consultation ReviewTumor Board & PresentationsQA/QC ReviewEducational/Research Image Analysis Incorporate Images Into Reports

Virtual Microscopy Image acquisition Image storage Image retrieval Real-time browsing Real-time consultation Image analysis Imaging of entire slide Each image ~ 0.4 Gb

Virtual Microscopy Image Acquisition Too expensive $0.91 per slide Throughput of imager Not sufficiently fast 6-7 minutes on average at 20X Image quality Not good enough for diagnosis Excellent at 20X; Diagnostically equivalent in most cases Image storage Too expensive $1.00 per slide - kept 30 days Reviewing images Too slow Real-time virtual microscopy

ACIS

Zeiss/Trestle with Slide Loader

Selecting the Hardware  Hardware is a commodity.  It will be out of date as soon as you purchase it.  It was out of date as soon as the vendor starting building it.  Hardware will always become better, faster and cheaper.  Will the vendor be in business in 5 years  Is the vendor solving my problem or a different problem  What is the total cost of ownership  Cost, training, maintenance, repeats No different than buying IHC, Flow, FISH, Molecular Equipment

Problem being solved Pathologist needs access to tests and/or expertise that is not available locally –Traditionally, the pathologist is at the mercy of the reference lab or university pathologist Ability to seek another opinion instantly Achieve near real-time results (order stain, results back at the speed of instruments and scanners NOT fed-ex overnight) We want the local pathologist to retain as much control as possible. –Access to test result and/or slides as soon as they are ready –Ability to review slides with experts –Ability to provide up to date results at tumor board even if case is not yet completed

Clarient Consultat ive Network Local Pathologist reviews complex tumor. Needs to order special studies Monday Morning Monday Evening Tuesday Morning Tuesday Evening Sent to Clarient via local courier + airlines Stains performed and scanned Local Pathologist reviews case on PathSite. Orders consultation Expert University Expert University Report returned Stains performed and scanned Local Pathologist releases results to clinician

The Consultative Team Hector Battifora Larry Weiss Shriram Jakate Neal Goldstein Keith Kaplan Ossama Tawfik Scott Binder Noel Weidner Jeff Myers

The Consultative Team City of Hope University of California, Los Angeles University of California, San Diego Rush University University of Michigan University of Kansas Mayo Clinic Yale University Beth Israel, Boston

The Process Call, , page consultant or daily login Go to Clarient Home Page Login Worklist loads automatically Click on case Review Slides - Take images Order tests if necessary Prepare report Call submitting pathologist

Clarient Home Page

Login to System

Review Worklist - Select Case

Review Slides

Virtual Slide

Order Additional Tests

Review Images

Prepare Report

Virtual Multi-headed Scope Conference with Experts

Change is inevitable, except from vending machines Woody Allen

Thank you!

Production genius or marketing genius  Henry Ford  Did he conceive the concept of an assembly line after discovering that could not sell cars for more than $500 or did he invent the assembly line because he had already determined that he could not be successful selling cars for more that $500. Harvard Business Review, October 2006