Evaluating a New Diagnostic Assay: Industry Perspective

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Evaluating a New Diagnostic AssayIndustry
Perspective

• Jim Koziarz
• Abbott Laboratories

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Presentation Outline

• The challenge presented by SARS
• Industry recommendations
• Implications to product evaluation and approval

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The Challenge

• Sporadic outbreaks of SARS in diverse geographic
  locations
• Syndromic patient management
• Pathogenesis not characterized
• Patient sampling and sample handling not
  standardized
• Limited opportunity for prospective clinical
  trials

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The Challenge

• Not a traditional test development task
• Can be a model for response to bioterrorist
  attack
• Requires close cooperation between industry and
  government agencies to expedite response
• Safety, efficacy, and compliance must be addressed

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Industry Recommendations

• Meeting held with representatives of industry and
  governmental agencies on May 29, 2003
• Participants
• FDA, CDC, HHS
• AdvaMed Abbott Laboratories
• Becton Dickinson bioMerieux
• GenProbe OrthoClinical Diagnostics
• Quidel Corporation Roche Diagnostics
• Thermo-BioStar Immunetics

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Industry Recommendations

• General Objectives
• A strong public-private partnership that
  expedites research, development and approval of
  diagnostics for emerging pathogens. The
  interaction between industry, FDA and CDC on the
  development of a West Nile Virus test provides a
  good template for the type of partnership and
  interaction that is needed.
• Build on the core competencies of the FDA
  (approval of safety and effectiveness), the CDC
  (epidemiology, lab consultation and specimen
  repository), and industry (Quality Tests and Good
  Manufacturing Practices).

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Industry Recommendations

• Policy Recommendations
• Convene a public meeting on SARS
• Integrate CDC communications into quarterly
  FDA/Industry Roundtable
• Develop guidelines for clinical study and FDA
  approval standards
• Agreement on key elements that must be addressed
  and on risk mitigation
• Expedited approval process allowing postmarket
  surveillance
• Identify points of contact at FDA and CDC
• CDC to serve as clearinghouse for samples of
  emerging pathogens

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Industry Recommendations

• Issues with Rapid Development of Tests for
  Emerging Pathogens
• RD funding
• Intellectual property
• Sample acquisition and characterization
• Regulatory requirements for test approval
• Reimbursement for new tests

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Implications

• Goals of clinical validation of new test method
• Demonstration of medical benefit
• Indication based on test result to diagnosis and
  patient management
• Linkage to patient history, symptoms
• Experience of product in intended use population
• Product performance with sample type
• Sensitivity and specificity

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Implications

• Product life cycle model
• Risk management and mitigation
• FMEA
• Component reuse where appropriate
• Feedback loop to product labeling
• Enhance product performance and labeling as more
  data becomes available

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Proposed PMA Plan for SARS Test

• Intended Use
• Limit to detection of coronavirus
• Supplement patient diagnosis with CDC guidelines
• Data Set
• Submit data gathered to date from sources around
  the world
• Labeling
• Provide sensitivity and specificity by sample
  type
• Clearly state test limitations
• Post Approval
• Repeat studies at multiple sites
• Well-documented and characterized samples
• Supplement PMA as required

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Example of SARS Clinical Studies

• Toronto
• 22 post-mortem lung tissue samples from 11 SARS
  patients
• Singapore
• 1153 samples comprising stool, blood, swab,
  sputum, urine, and others
• Germany
• 338 pools comprised of 96 single donations each
  (32,448 donations)
• Toronto
• 250-300 specimens representing the following
  sample types stool, urine, sputum, and swabs
• Paris
• Evaluation of samples of acute phase SARS
  outbreak in Vietnam

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Proposed PMA Plan for SARS Test

• Feedback Mechanisms
• Post approval meetings with agencies to review
  product performance
• Quality system data (internal and external) used
  to monitor test performance and identify
  improvement/enhancement opportunities under
  Design Control
• Scientific feedback on virology and pathogenesis
  to suggest next generation products
• Collection of clinically relevant samples for
  Quality Control and validation of next generation
  tests

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Summary

• SARS presents a case for the rapid development
  and deployment diagnostic tests
• Sample acquisition limits our ability to perform
  extensive product validation studies
• There are opportunities for the diagnostic
  industry to respond to threats like SARS in a
  rapid, safe, and compliant manner
• Close cooperation and communication between
  industry and government agencies is key to
  accomplishing this