Lab Attendance 2018

1. F2F Agenda
2. BE/BS/RELSPEC proposal review
3. Question from Janssen regarding phosphorylated protein assays.

• Discuss F2F Agenda - done
• Discuss BE/BS/RELSPEC proposal from Chris C - done
• Nik P question about phosphorylation sites (for TAU Protein)

                                                               i.      The analyzing lab is measuring the amount of TAU protein that is phosphorylated on specific phosphorylation sites. CDISC CT has existing terminology (C84811, C84810, C84812) but not specific phosphorylation site TAU. Question: what to do about info on phosphorylation sites: Pre-coordinate into test or use a NSV?

                                                                                 i.            Covance reports phosphorylated positions as separate test codes

                                                                               ii.            LOINC puts it into the component name.

                                                                              iii.            This may cause an explosion of terminology if we precoordinate but using separate variables would make analysis more complex.

                                                                             iv.            Lab CT has not yet had to deal with a new term request regarding this issue.

                                                                               v.            The PGxIG may have some useful variables with regards to this kind of modeling. This may also be relevant to Microbial serotypes and antibody testing.

                                                             ii.      They are also measuring how much of the phosphorylated TAU is bound to the JnJ drug(s).