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 3 rd 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