NEW YORK – Qiagen announced on Tuesday that it has obtained the CE mark for its QuantiFERON-TB Gold Plus tuberculosis blood test under new in vitro diagnostic regulations.
Qiagen said in a statement that the certification marks a milestone in the firm's transition to full compliance with new European Union regulations for IVD performance and safety. The new EU regulation, called 2017/746 In Vitro Diagnostic Medical Devices Regulation (IVDR), is replacing a previous regulation known as 98/79/EC In Vitro Diagnostic Directive (IVDD).
Qiagen said under the new more stringent EU regulation, the QuantiFERON-TB Gold Plus assay is classified under Class C. It is endorsed by the World Health Organization.
The IVDR certification of QuantiFERON-TB Gold Plus follows the certification of the firm's ipsogen JAK2 RGQ PCR Kit and its NeuMoDx Systems and reagents, which gained IVDR CE-marking in late 2022.
"Our teams have been able to demonstrate that QuantiFERON-TB Gold Plus is compliant to the IVDR requirements through stringent regulatory review," said Jean-Pascal Viola, Qiagen's senior VP and head of the molecular diagnostics business unit.
Qiagen said it will transition more than 180 products to IVDR CE-marking.