NEW YORK – Bio-Rad Laboratories announced Wednesday that it has received the EU Quality Management Systems Certification under Europe's In Vitro Diagnostic Regulation, which will enable the CE marking of 40 infectious disease molecular quality controls.
Among the Exact Diagnostics-branded quality controls that can now be CE marked are controls for tests for adenovirus, Anaplasma, Babesia, Bartonella, Borrelia, cytomegalovirus, chlamydia and gonorrhea, enterovirus, human papillomavirus, herpes simplex virus, parvovirus, and SARS-CoV-2.
The firm's CT/NG Positive Run Control and STI Negative Run Control will be the first products CE-marked under IVDR, Bio-Rad said in a statement. They are expected to be released at the end of Q1 2025 with the remaining products to follow.
The quality controls are formulated with whole organisms in relevant matrices to simulate patient specimens, which ensures that the controls undergo the same workflow and process challenges as patient specimens during routine testing, Bio-Rad added. Each positive control can be paired with a corresponding negative control.
The remaining controls in the Exact Diagnostics portfolio will be submitted soon for certification, the company noted.