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Global Biomarker Standardization Consortium

Global Biomarker Standardization Consortium. Chairs: Holly Soares, Henrik Zetterberg, Piotr Lewczuk. TEAM OBJECTIVES.

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Global Biomarker Standardization Consortium

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  1. Global Biomarker Standardization Consortium Chairs: Holly Soares, Henrik Zetterberg, Piotr Lewczuk

  2. TEAM OBJECTIVES • To create a certified reference material (i.e. human CSF pools) that can use by assay developers to create a gold standard for absolute and accurate measures of CSF Aβ42 and T-Tau. • To create universal reference calibrators that can be used in the antibody independent reference method to measure absolute concentrations of CSF AB42 and T-tau • To create a large pool of quality control material that the end user lab could use to check assay precision.

  3. Certified Reference Material • Many options • Immunodepleted matrix spiked in with endogenous peptide or engineered peptide • Matrix equivalent spiked in with endogeneous peptide or engineered peptide. • Native material (e.g. human CSF pools) • Team agreement • Human CSF pools of sufficient quantity to provide primarily assay developers for 1-3 years. • Action Item: companies to get answer specific questions

  4. Questions for company • Where are companies (both IVD and pharma) getting as starting materials for both ab42 and tau? • How to get common starting point of the materials? • INNX-Manu able to report small overview presentation for next call; Source materials and share materials for next meeting • Would like to hear from all companies about what they can and can’t share to the group. • George Green to give update on outside 3rd party opportunity. • Henrik to give update on IFCC (?) from Dec. 16 (from JPMD mtg)

  5. Issues • Does group scope include collection of CSF pool or stop at certified ref materials? • Cancel 19dec and meet next in Jan 2012 • Holly to take first draft and send to all for input before we get those questions to IVD and pharma company permissions. • Henrik and Kaj to give overview of QC program. • Review process to take 3 weeks in one company’s estimate, thus attempt to get questions as quick as possible to enable internal company preparation and approval.

  6. CRM Actions/notes 11/29/11 • Henrik has submitted a proposal to IFCC to make reference material for analytes and it was approved. • IFCC would observe the project and IRMM would be actively involved as a partner that would guide the creation of the reference material. • IFCC requires a reference method. • The most feasible approach is to create a large pool and then test the pilot ref material for stability, homogeneity and stability. • Henrik will update team on IFCC and IRMM activities at December call. • Request more information from assay developers regarding reference materials • Manu (INNX/FBI) and Pankaj (MSD) to inquire on whether data can be shared • Holly to invite OCD/SBI and Roche to team discussions

  7. Update QC program 11/29/11 • Calibrators discussion will be tabled. And on the next call we should have a discussion to talk about the next steps there. • QC issues: currently there are a few efforts towards this end, Bob asked that perhaps on another call we could have a discussion of the QC programs. • Maria will schedule a webinar for later to do a good comparison between the two, the AA CSF QC and the German project of Piotr.

  8. AGENDA 12 Dec 2011 • Review of Objectives • Review of Action items • Introduction additional assay manufacturers • USDS reference calibrator proposal • Next steps

  9. Future Call Dates • Monday 12/12 - 6:30 am PST / 8:30 am CST / 9:30 am EST / 3:30 pm Sweden • Monday 12/19 - 6:30 am PST / 8:30 am CST / 9:30 am EST / 3:30 pm Sweden

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