Question to the Department of Health and Social Care:

To ask Her Majesty's Government when they first became aware of the Roche Elecsys Anti-SARS-CoV-2 antibody test; what discussions they held with the European Medicines Agency and stakeholders in Germany about their trials and approval processes; and why they decided to run their own separate trials and approval process.

Public Health England (PHE) were asked to review all major suppliers of assays for National Health Service use, including the Roche Elecsys Anti-SARS-CoV-2 antibody test, in order to limit the amount of on-site evaluation each facility has to perform.

PHE is familiar with the processes involved in European Medicine Agency registration. No discussions have been held with stakeholders in Germany about their trial and approvals processes.