Dive Brief:

• Roche received the first In Vitro Diagnostic Regulation (IVDR) certificate for a companion diagnostic, according to the notified body that assessed the device.
• The notified body TÜV SÜD Product Service issued the certificate to a qualitative immunohistochemical cancer biomarker assay that detects expression of PD-L1.
• Receipt of the certificate clears Roche to sell a companion diagnostic for immune checkpoint inhibitors in the European Union because it has shown conformity to the IVDR requirements.

Dive Insight:

IVDR is changing the regulatory status of companion diagnostics, the tests that show whether a drug is appropriate for a particular patient and how well it is working in a course of treatment. Under the outgoing regulatory system, companies could place companion diagnostics on the European market without undergoing conformity assessment by a notified body. IVDR categorizes companion diagnostics as Class C devices and, as such, they need to undergo conformity assessment before being placed on the market. 

Roche is the first company to complete the process for a companion diagnostic. The IVDR certificate covers a test for expression of PD-L1, a biomarker that influences how likely a cancer patient is to respond to immune checkpoint inhibitors such as Merck & Co.’s Keytruda and Roche’s Tecentriq.

Andreas Stange, vice president IVD global, medical and health services at TÜV SÜD, said the IVDR certificate is evidence of the growing maturity of the new regulatory framework in the European Union.

“The certificate now issued marks a major milestone, demonstrating that two different EU legislations are working effectively together and that this additional IVDR consultation procedure has been successfully implemented by TÜV SÜD,” Stange said in a statement.

News of the companion diagnostic IVDR certificate arrived about five months after TÜV SÜD named Roche as the recipient of the first IVDR certificate for a Class D medical device. Class D covers the highest-risk medical devices. Products in the class must complete a process involving notified bodies and EU reference laboratories to come to market under IVDR. Roche received the certificate for a COVID-19 antibody test.