# Presentation: 821020

## 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

- 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 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

- 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

## 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 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 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

## 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

## 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

## 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

- 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 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

## 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