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Notes of 21nov2011

Notes of 21nov2011. Alz . Assoc. CSF Reference Method Sub-group. Goal. Quantify concentration of analyte as accurately as possible in the reference material to then be used to compare other methods and platforms available…. Methods to evaluate (for pros/cons).

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Notes of 21nov2011

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  1. Notes of 21nov2011 Alz. Assoc. CSF Reference Method Sub-group

  2. Goal • Quantify concentration of analyte as accurately as possible in the reference material to then be used to compare other methods and platforms available…

  3. Methods to evaluate (for pros/cons) • MRM published by Waters et al… (need cite) • Absorbance based methods • PPD (Randy Jenkins)- Assay from ICAD poster • Proteome Sciences - “validated” ab42 assay • C2N – quant ab42 and “total ab” assay • Immunoassay based approaches • MSD, Myriad RBM, INNX/Fujirebio • Manu Vandijeck had a new methodogy from Ab42 std working group… • Note: need request validation reports from each.

  4. Reference Methods Issues • Issue: are we considering what is available today or what may need to get developed • Consideration of pre-analytic methods and their impact on the analytical methods • Oligomervs monomer of Ab42 • What is the minimum validation required? What is the quality standard? • What is overall target goal? FDA clearance or approval, operate in research space only? • Resources to achieve the goals? • Suggest pull EMA opinions based on BMS submission regarding CSF biomarkers • MSD-RUO initially, require more than MSD alone if tied to drug or indication, working on how take to next level, what are clinical study design and samples for a PMA . . . • Invite DX companies: OCD, Roche to the “table”, CRO have done “validated” Pfizer/ICON, • Issue: is method/assay validated and available? Where should it be done?

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