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Evaluating a New Diagnostic Assay: Industry Perspective. Jim Koziarz Abbott Laboratories. Presentation Outline. The challenge presented by SARS Industry recommendations Implications to product evaluation and approval. The Challenge.

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Evaluating a new diagnostic assay industry perspective

Evaluating a New Diagnostic Assay:Industry Perspective

Jim Koziarz

Abbott Laboratories

Presentation outline

Presentation Outline

  • The challenge presented by SARS

  • Industry recommendations

  • Implications to product evaluation and approval

The challenge

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

The challenge1

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

Industry recommendations

Industry Recommendations

  • Meeting held with representatives of industry and governmental agencies on May 29, 2003

  • Participants:

    • FDA, CDC, HHS

    • AdvaMedAbbott Laboratories

    • Becton DickinsonbioMerieux

    • GenProbeOrthoClinical Diagnostics

    • Quidel CorporationRoche Diagnostics

    • Thermo-BioStarImmunetics

Industry recommendations1

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).

Industry recommendations2

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

Industry recommendations3

Industry Recommendations

  • Issues with Rapid Development of Tests for Emerging Pathogens

    • R&D funding

    • Intellectual property

    • Sample acquisition and characterization

    • Regulatory requirements for test approval

    • Reimbursement for new tests



  • 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



  • 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

Proposed pma plan for sars test

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

Example of sars clinical studies

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

Proposed pma plan for sars test1

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



  • 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

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