Roche Secures First-Ever EU IVDR Certificate for Companion Diagnostic Test

• Roche Obtains the First Companion Diagnostic In Vitro Diagnostic Regulation (IVDR) Certificate.

• Notified Body TÜV SÜD Issues Certificate for Qualitative Immunohistochemistry Cancer Biomarker Test Detecting PD-L1 Expression

• After receiving this certificate, Roche is allowed to sell the companion diagnostic product for immune checkpoint inhibitors in the EU, which has been shown to comply with IVDR requirements.

IVDR is changing the regulatory status of companion diagnostics, which are tests that show whether a drug is suitable for a specific patient and how effective it is during a treatment process. Under the soon-to-be-expired regulatory system, companies can place companion diagnostic reagents on the European market without undergoing a conformity assessment by a Notified Body. The IVDR classifies companion diagnostic devices as Class C devices, thus requiring them to undergo a conformity assessment before entering the market.

Roche was the first company to complete the companion diagnostic review. The IVDR certificate covers testing for PD-L1 expression, a biomarker that can influence the degree of response in cancer patients to immune checkpoint inhibitors such as Merck & Co.'s Keytruda and Roche's Tecentriq.

Andreas Stange, Vice President of IVD Global Healthcare Services at TÜV SÜD, stated that the IVDR certificate is evidence of the growing maturity of the EU's new regulatory framework.

Stanche said in a statement: "The issuance of the certificate today marks an important milestone, demonstrating that two different EU legislations are working effectively together, with this additional IVDR consultation process successfully implemented by TÜV SÜD."

About five months after TÜV SÜD named Roche as the first applicant for a Class D medical device IVDR certificate, the companion diagnostic IVDR certificate has finally been issued. Class D includes the highest-risk medical devices. Products in this category must complete a process involving a Notified Body and an EU Reference Laboratory to enter the market under the IVDR. Roche obtained the certificate for its COVID-19 antibody test.