TÜV SÜD issues the first IVDR certificate for an IVDR companion diagnostic CDx from Roche Diagnostics.

The CDx is a cancer biomarker assay used to identify patients who are most likely to benefit from a specific therapeutic treatment. The CDx is used in the oncology care pathway and is manufactured by Roche Diagnostics GmbH.

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.

Companion diagnostics (CDx) are key diagnostic tools to further enhance the emerging field of personalised medicine. CDx devices are clinically validated to identify patient populations, allowing more individualised treatment based on a specific patient’s likelihood of response.

Today’s announcement further builds on TÜV SÜD’s strong track record in IVDR implementation, as the issuer of the world’s first IVDR certificate in October 2020 and the world’s first Class D certificate in July 2022. TÜV SÜD is proud to serve as a strong and reliable Notified Body for manufacturers and to help bring compliant IVDs to market by performing the implementation of the additional consultation procedures required for high-risk products such as Class D and/or CDx within an efficient timeframe.

The IVDR introduced a new concept of risk classification for IVDs as well as a reorganisation of the conformity assessment process. In general, the mandatory Notified Body involvement for IVDs to achieve CE-mark approval has increased significantly, from approximately 15 per cent of IVDs with NB certification to the present level of more than 80 per cent of IVDs.

Companion diagnostics is one of the device categories that could be placed on the EU market by the manufacturer without Notified Body involvement under the previous EU regulatory framework (IVD Directive, 98/79/EC). These clinically valuable products are now classified as Class C and need to undergo a newly established Notified Body conformity assessment, in which the Notified Body is required to consult the respective Competent Authority (CA) for medicinal products according to the 2001/83/EC directive or the European Medicines Agency (EMA).

The involvement of an additional stakeholder – in the form of the EMA or the respective CA – increases the time needed for the overall Notified Body conformity assessment process, and this must be taken into consideration by companion diagnostic manufacturers. After the recent modification of the IVDR transitional provisions in January 2022 set out in Regulation (EU) 2022/112, the IVDR now requires Class C CDx products to be CE-marked with the involvement of a Notified Body such as TÜV SÜD Product Service GmbH by May 2026.

The consultation of the EMA or the respective CA for a medicinal product is a new concept in the IVD EU regulatory framework on which representatives of the EMA and Notified Bodies have been working for some years. “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”, says Dr Andreas Stange, Vice President IVD global at Medical & Health Services at TÜV SÜD.

The certified CDx is a qualitative immunohistochemical cancer biomarker assay designed to detect the programmed death-ligand 1 (PDL1) expression pattern to identify patients who will benefit from a specific therapeutical treatment. Dr Heike Möhlig-Zuttermeister, Head of Business Unit Line IVD at Medical & Health Services at TÜV SÜD comments, “It is great to see this highly patient-critical CDx being placed on the EU market in compliance with the IVDR with a CE-marking based on a conformity assessment procedure. The CDx thus can now provide actual direct clinical benefit – such as higher tumour survival rates – for an identified patient population undergoing a specific therapeutical treatment. This first CDx certification also demonstrates the effectiveness of IVDR implementation activities by all the stakeholders involved: the manufacturer, the EMA and TÜV SÜD Product Service GmbH as the Notified Body.”