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Overcoming Assay Development Challenges for Prion Testing: Regulatory Pathways and Strategies

This presentation addresses the critical challenges in developing prion assays, including regulatory pathways to market, issues related to sensitivity and specificity, and the availability of human and animal samples. A comprehensive overview of the regulatory landscape highlighting performance evaluation and compliance with EU directives will be presented. It emphasizes the need for open communication between manufacturers and regulators to navigate the complexities of assay development for prion diseases effectively. Strategies for validation and verification of assays will also be discussed.

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Overcoming Assay Development Challenges for Prion Testing: Regulatory Pathways and Strategies

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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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