Automation in Toxicologic Pathology Dr' Gary L' Knutsen, President

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Automation in Toxicologic Pathology Dr.
Gary L. Knutsen, President Managing
MemberSystems Pathology Company, LLC
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Why SPC is Developing CAPS
Pathology Resources
Productivity Objectivity

• HistoQC Slide Screening

• Look Here Feature

• IND Studies 85-90 Normal Tissues

• Blind Shuffle Efficiency w/ Group Comparisons

• Normal vs. Non-normal Tissues Screening

• Enhanced Peer Review PWG Processes

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SPC is a pathology-based software company
developing the next generation of image analysis
products to augment traditional toxicologic
pathology practices.
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Company Background Development History
Initial Development Partners
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The Pieces Existed but were not Aligned
Hardware Software
CAPS doesnt require a consortium to succeed but
cooperative collaboration within the Industry is
a must!
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The Future with CAPSFully Integrated Workflow
More Accurate Predictive Toxicology
Improved Translational Medicine
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The SPC CAPS Development Process
Specimen Access
Specimen retrieval with supporting SPC
Toxicologic Pathologists
Federal Agencies, Academia Institutes
End User Participation
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CAPS Product Release Schedule
CAPS 1.0 - First Commercial Release 5 Tissues in
Rat (non-GLP)
CAPS 2.0 All GLP tissues for three species
Rat, Dog Non-human Primate
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Automated Toxicologic Pathology
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• Retrieves Historical Normals to define baselines
  for QC and Normal/Non-normal for study
• Study Slides are evaluated by HistoQC for
  quality control
• Evaluates Study Controls with respect to
  Historical Normals NormalGreen,
  Non-normalYellow
• Evaluates Study Treated animals with respect to
  Study Controls NormalGreen, Non-normalRed
• Pathologist Reviews the Study via the Pathology
  Heatmap, Graphs Analytic Tools

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Anticipated Efficiencies
Estimated 7 full days of actual histopathology
evaluation - including entry in DMS
Traditional Histopathology Approach

• Day 0
• Overnight Automated Analysis
• HistoQC Screening
• Normal v. Non-normal Analysis

• Pathologists Time CAPS - (2) days of image
  exam v. traditional (7) days _at_ scope
• CAPS Report 1 week v. traditional 3 plus weeks

• End of Week 1
• Evaluation completed
• Report preparation initiated

HistoPATH Approach
Week 1
Week 2
Week 3
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Impact of CAPS Automation

• Fully automated, unattended and objective
  histology quality control screening
• Reduce slide reading (histopathology) time of the
  toxicologic pathologist by 50-60
• Decrease diagnostic time (Look Here Features)
  and reduce blind slide shuffling exercises by
  an additional 10-15
• Provide fully automated and unattended
  quantitative analysis (determination of severity
  gradients) and statistical guidance on no effect
  level of select tissue changes
• Automated statistical and graphic comparison of
  treated animals to historical normal, historical
  controls and/or study controls
• Enable the pathologist (the time and data) to
  bring added value - interpret biological
  significance and translational predictivity
• Extend the life expectancy of the toxicologic
  pathologistand for that
• and with thatI thank you!

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Before CAPS Smart Imaging
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After CAPS Smart Imaging