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Digital Pathology in the Era of Global Clinical Trials: Improving Quality and Consistency

Digital Pathology in the Era of Global Clinical Trials: Improving Quality and Consistency. Ron Luff, MD, MPH. Global Reach. UK. Belgium. USA. China. India. Singapore. Australia. Quest Diagnostics Clinical Trials Laboratories & Offices. Affiliate Laboratories.

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Digital Pathology in the Era of Global Clinical Trials: Improving Quality and Consistency

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  1. Digital Pathology in the Era of Global Clinical Trials:Improving Quality and Consistency Ron Luff, MD, MPH

  2. Global Reach UK Belgium USA China India Singapore Australia Quest Diagnostics Clinical Trials Laboratories & Offices Affiliate Laboratories

  3. Proprietary Facilities:US, UK, and India • Two facilities in Los Angeles (Lab and Project Mgmt), plus a lab in San Juan Capistrano, CA (Nichols Institute), a lab in Teterboro, NJ and an administrative facility in Collegeville, PA • >300 US employees • Service Areas include: • North America • Central America • South America • Australia • South East Asia • Two facilities near London (Heston – Lab; Hounslow – Proj. Mgmt), plus Project Mgmt in Wavre, Belgium • ~300 EU employees • Multiple language expertise • Services Areas include: • Europe • Middle East • Africa • India • New 65,000 sq.ft. laboratory in Gurgaon, India (New Delhi); supporting local investigators / trials and global clinical trials • Service Areas include: • India • Pacific Region

  4. Core Competencies by Therapy

  5. Cellular Pathology, circa 1858-present • Light microscopy “art-form” • Variation of diagnoses among • “experts” • “Truth” often determined by • majority rule in adjudication • for clinical trials cases

  6. Digital Pathology San Juan Capistrano, CA Chantilly, VA NAS NAS WAN 5tb CIFS Share 5 tb CIFS Share NS40 PSI NS40 PSI QDC CLARiiON 146 GB SQL/Server Meta Data Database Digital Cellular Pathology, circa 1996-present • Quest Diagnostics’ reference laboratory placed 4 scanners in 2007 (Nichols Institute) • Primary use • Remote viewing of reference IHC cases in a faster, yet equally accurate manner • Digital analysis when requested (eg, Ki67 quantitation)

  7. Digital Pathology for Clinical Trials,circa 1996-present • Reduce variation of diagnoses and allow for “remote” prospective reads by central pathologist(s) • Standardization among different labs

  8. Digital Pathology for Clinical TrialsAdditional Advantages • Long-term storage of images • “Digital” slide • No risk of breakage and stain fade • Enables use of tissue section for other purposes (eg, DNA studies) • Remote “anytime” access to digital slides • Enables trial sponsors to study slides • Conferencing capabilities • Multiple people can review slides simultaneously

  9. Digital Pathology for Clinical TrialsAdditional Advantages • Digitized slides can substitute for tissue/ cytology samples when global trial host country restricts exportation • Digital analysis can be used for • Quantifying stains • Microvessel density assessment • Rare event detection • Protein quantitation within cellular compartments when used in conjunction with immunofluorescence

  10. Epidermal Growth Factor Receptor (EGFR) • Part of a family of four related cell surface tyrosine kinase receptors • Often mutated and upregulated in epithelial cancers (NSSC of lung, head and neck squamous carcinoma, colon adenocarcinoma) • Overexpression predicts response to certain therapies (eg, gefitinib) • EGFR status determined by FISH or immunohistochemistry (IHC) staining – until recently, subjective interpretation

  11. IHC Staining for EGFR 20X 400X Strongly Positive ??Positive

  12. Digital Assessment • Digital computerized assessment of membrane receptor • 3+ Cells = 174 • 2+ Cells = 153 • 1+ Cells = 78 • 0+ Cells = 36 • Total Cells = 441 Analysis provided by Trevor Johnson, Aperio.

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