March 14, 2025—Bio-Rad Laboratories has received the EU quality management systems certificate under IVDR regulation (EU) 2017/746, enabling the CE-IVDR marking of 40 Exact Diagnostics infectious disease molecular quality controls. The controls are formulated with whole organisms in relevant matrices to simulate patient specimens. This design aims to ensure that the controls undergo the same workflow and process challenges as patient specimens during routine testing.
The products include controls for adenovirus, Babesia, BK virus, cytomegalovirus, CT/NG, enterovirus, HPV genotypes 16 and 18, parvovirus, SARS-CoV-2, Zika virus, and many others. The CT/NG positive run control and STI negative run control will be the first products to be CE marked under IVDR, with an estimated market release at the end of Q1 2025.