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Manufacturers Perspective

Manufacturers Perspective. Alisha McReynolds Prion 2006 05 October 2006 Turin, Italy. Agenda for Presentation. Overview of Assay Development Challenges Regulatory Paths to Market for a Prion Assay Overview of Regulatory Challenges Proposed Performance Evaluation Next Steps.

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Manufacturers Perspective

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  1. Manufacturers Perspective Alisha McReynolds Prion 2006 05 October 2006 Turin, Italy

  2. Agenda for Presentation • Overview of Assay Development Challenges • Regulatory Paths to Market for a Prion Assay • Overview of Regulatory Challenges • Proposed Performance Evaluation • Next Steps

  3. Overview of Assay Development Challenges • Biology Unknown levels and prevalence of prions in blood donations • Disease models Relevance of animal models • Sample Availability Limited human vCJD plasma samples available with small volumes • Confirmation Test None available in vitro • Sensitivity and May be difficult to achieve high Specificity sensitivity/specificity • Incidence Declining incidence- Is testing needed?

  4. Regulatory Paths to Market for a Prion Assay • CE marking • Manufacturer ensures product meets Directive requirements- essential requirements, addressing risk(s) • Declaration of conformity • Notification to Competent Authority in each country • Post market requirements, post market experiences including incident reporting • Competent Authority has 2 years after notification of ‘new’ product to require documentation of post market surveillance for review (IVDD Article 11) • Currently, a prion assay is not listed in the IVD Directive and is not included in the Common Technical Specifications • Performance evaluation • Parallel to clinical development • Early epidemiological data

  5. Overview of Regulatory Challenges • Currently not an Annex II List A product • No Common Technical Specifications • Availability of blood samples from vCJD patients for assay development • Correlation of animal models used in assay development to a commercial assay used to screen human blood donors • Infectivity Studies • Confirmatory Testing

  6. Overview of Regulatory Challenges Continued… • Commercial Assay Kit Positive Control • Transportation • Donor Management • Laboratory Decontamination

  7. Proposed Performance Evaluation • Specificity • Donor samples • 5000 (high prevalence) • 5000 (low prevalence) • Hospitalized patients • 100 non-neurodegenerative patients • 100 neurodegenerative patients • Interfering substances • Bilirubin, Rheumatoid factor, Human anti-mouse antibodies, etc

  8. Proposed Performance Evaluation • Sensitivity • All available vCJD plasma samples • >40 Symptomatic sCJD plasma samples • Animal disease course samples

  9. Questions for a Proposed Performance Evaluation • Specificity • Donor samples • 5000 (high prevalence) • 5000 (low prevalence) • Is this enough? What is enough?

  10. Questions for a Proposed Performance Evaluation • Sensitivity • All available vCJD plasma samples • Small number of samples available with small volumes. Limited availability for manufacturers. • Symptomatic sCJD plasma samples • Is this appropriate? • Animal disease course samples • What is the best animal model? What is the appropriate number of samples?

  11. Next Steps… • Open communication between industry and regulators • Regulatory surety needed • Inclusion in Annex II? • Standards for validating/verifying assays

  12. Thank you !! European Diagnostic Manufacturers Association Place des Maïeurs 2 1150 Brussels Belgium Tel +32 2 772 22 25 Fax +32 2 772 23 29 edma@edma-ivd.be EDMA represents the In Vitro Diagnostics Industry in Europe. Visit our website:www.edma-ivd.be Questions?

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