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Jeffrey Fine MD, Rohit Bhargava MD, Urvashi Surthi PhD, and David Dabbs MD

HER2 Immunohistochemistry: Workflow Experience with Image Analysis Based Interpretation of CB11 and 4B5 Clones. Jeffrey Fine MD, Rohit Bhargava MD, Urvashi Surthi PhD, and David Dabbs MD Magee-Womens Hospital of UPMC. Disclaimer.

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Jeffrey Fine MD, Rohit Bhargava MD, Urvashi Surthi PhD, and David Dabbs MD

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  1. HER2 Immunohistochemistry: Workflow Experience with Image Analysis Based Interpretation of CB11 and 4B5 Clones Jeffrey Fine MD, Rohit Bhargava MD, Urvashi Surthi PhD, and David Dabbs MD Magee-Womens Hospital of UPMC

  2. Disclaimer • One of the abstract authors (David Dabbs) is a consultant for Ventana • None of the other authors have any conflicts of interest to report

  3. Objectives • Overview of Her2/NEU testing (IHC) • Recap of validation results • Discuss implementation of image analysis

  4. Her2/NEU • Test for responsiveness to Trastuzumab (Herceptin) • Trastuzumab is cardiotoxic and is very expensive • False positives are highly undesirable • Trastuzumab can increase survival or reduce risk of recurrence • False negatives are also undesirable

  5. CAP HER2-A Survey (Spring 2007) • 40 TMA cores (4 slides) • Stained/interpreted at institutions (350ish) • Consensus (>80%) in 22 of 40 cases • Very variable

  6. IHC Variables • Pre-analytic • Fixation issues, tissue processing • Analytic • Validation, Calibration, Antibody clone, Antigen retrieval, Automation, Controls, etc. • Post-analytic • Interpretation criteria • QA procedures • Image analysis (17.9% reported using it)

  7. Validation of IA at UPMC • Formalin fixed (8-48 hours) paraffin embedded tissue • Automated IHC platform (Ventana) • CB11 and 4B5 antibodies (Ventana) • VIAS (Ventana Image Analysis System) • FISH (Vysis)

  8. VIAS (image from vendor)

  9. Validation Results I • System differentiated between tumor and stroma (subjective impression) • Pathologist had to find invasive tumor (and exclude in-situ tumor)

  10. Classification (Tumor vs. Stroma)

  11. Results CB11 • 100% Concordance with FISH (n=52) • 0/1+ IHC with no amp by FISH • 3+ with amp by FISH • FISH rate (2+ rate): • Expert 22.9% (n=118) • VIAS 21.2% • (expert was also 100% concordant)

  12. Results 4B5 • 94.6% Concordance with FISH (n=56) • 100% Concordance with new reference range • FISH rate (2+): • Expert 21.9% (n=114) • VIAS 28.9% (n=117) • *new reference range

  13. Reference Range • VIAS assigns a raw number score to each case which is then rounded to the nearest whole number. • Out of the box—score 2.5 or higher was rounded to “3+” • New range is conservative—only cases with score 3.5 are called “3+”

  14. Demixed to show brown

  15. Office Mailbox Old Workflow Order Her2/NEU Retrieve IHC Stain Interpret Stain Dictate Results Sign out case

  16. IA Workstation Office Mailbox New Workflow Order Her2/NEU Retrieve IHC Stain Perform IA Dictate Results Sign out case

  17. Implementation Details • Billing • Fee code 88361 • Technical charge initiated by order in APLIS • Documentation • VIAS results printout retained with other case paperwork (requisition) • IHC results (ER/PR and Her2/NEU) dictated into canned text that includes VIAS blurb

  18. Documentation Support • Transcription • New “quick text” with VIAS sentence • Communication with Transcription Team • Slide/paper management personnel • Communication – do not discard results report • Back-up of data • Currently performed manually

  19. IA charged per “click” IHC Laboratory responsible for keeping an adequate supply of the click reagent Smart Card (100 tests) “Consumables” Image from nist.gov www site

  20. Training • Local Domain Expert (me) • Fellows • Selected Faculty • Other Faculty • Residents

  21. Status Report • IA is in production for a week • Bumps being ironed out • Transcription • Training • End experience varies

  22. Good • Should increase standardization • Recent switch to 4B5 clone – different appearance and possible differences in interpretation • Documented response to pressure for accurate Her2/NEU testing • Foot in the door for other IA applications • Vendor has been responsive and appears to want to improve shortcomings

  23. Bad • IA of new antibody is less accurate than that of discontinued antibody • Reference range work-around • Workflow involves “travel” and is more labor intensive than traditional method • Quality improvement but does not extend the pathologist • Operator error is possible • Data entry • Lighting • Focusing

  24. Future IA (More Automation) • Whole Slide Images (some systems do permit IA) • Slide could be scanned in the IHC lab, and results (with the electronic slide) delivered straight to the pathologist • Automated detection of invasive tumor • Transition of IA to non-pathologist staff • Electronic interfaces to support test ordering and resulting (no more paper print outs or dictation)

  25. Conclusions • IA is validated and should improve performance of Her2/NEU IHC testing by reducing post-analytic variability • Current IA set-up not ideal but an important first step: • Successful implementation in a busy academic setting • Revenue (digital pathology business case)

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