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This project aims to quantify analyte concentration accurately in the reference material to compare varied methods and platforms. Evaluate MRM, absorbance-based techniques, and immunoassay approaches. Address issues like oligomer vs. monomer of Ab42, resource allocation, and target goal achievement. Discuss FDA clearance, pre-analytic methods, and validation standards. Includes planning for MSD-RUO initiatives and inviting DX companies to collaborate.
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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) • 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.
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?