Transcript Document 7235388

Evaluating a New Diagnostic Assay:
Industry Perspective
Jim Koziarz
Abbott Laboratories
FDA Workshop on
SARS Diagnostics
Presentation Outline
• The challenge presented by SARS
• Industry recommendations
• Implications to product evaluation and approval
FDA Workshop on
SARS Diagnostics
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
FDA Workshop on
SARS Diagnostics
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
FDA Workshop on
SARS Diagnostics
Industry Recommendations
• Meeting held with representatives of industry and
governmental agencies on May 29, 2003
• Participants:
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FDA, CDC, HHS
AdvaMed
Becton Dickinson
GenProbe
Quidel Corporation
Thermo-BioStar
Abbott Laboratories
bioMerieux
OrthoClinical Diagnostics
Roche Diagnostics
Immunetics
FDA Workshop on
SARS Diagnostics
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).
FDA Workshop on
SARS Diagnostics
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
FDA Workshop on
SARS Diagnostics
Industry Recommendations
• Issues with Rapid Development of Tests for Emerging
Pathogens
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R&D funding
Intellectual property
Sample acquisition and characterization
Regulatory requirements for test approval
Reimbursement for new tests
FDA Workshop on
SARS Diagnostics
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
FDA Workshop on
SARS Diagnostics
Implications
• Product life cycle model
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Risk management and mitigation
FMEA
Component reuse where appropriate
Feedback loop to product labeling
• Enhance product performance and labeling as more data
becomes available
FDA Workshop on
SARS Diagnostics
Proposed PMA Plan for SARS Test
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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
FDA Workshop on
SARS Diagnostics
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
FDA Workshop on
SARS Diagnostics
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
FDA Workshop on
SARS Diagnostics
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
FDA Workshop on
SARS Diagnostics