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Roche Gains IVDR Certificate for Cancer Treatment Companion Dx

NEW YORK – TÜV SÜD said recently that it has certified a companion diagnostic manufactured by Roche under the EU's new In Vitro Diagnostic Regulation, adding it is the first such certification for a CDx.

Headquartered in Munich, Germany, TÜV SÜD provides product and system certification across numerous industries and maintains an extensive global presence. The firm's main entity, TÜV SÜD Product Service GmbH, is one of eight certification companies, called notified bodies, to be designated thus far to issue certificates under the IVDR, which began to apply on May 26, 2022.

According to TÜV SÜD, Roche's test is a qualitative immunohistochemical cancer biomarker assay designed to detect programmed death-ligand 1 (PDL1) expression patterns in patients, enabling users to identify patients likely to benefit from specific therapeutic treatment.

The assay is manufactured by Roche Diagnostics GmbH, based in Mannheim, Germany.

While manufacturers were able to self-certify most of their molecular assays under the previous law, 1998's In Vitro Diagnostic Directive, under the IVDR most must obtain a certificate from an NB such as TÜV SÜD. Certain classes of devices under the IVDR are considered higher risk and require conformity assessment with the assistance of a competent authority, such as the European Medicines Agency, an EU agency charged with overseeing pharmaceutical products.

Companion diagnostics are considered Class C devices, and based on staggered grace periods for legacy devices, test makers must obtain IVDR certificates for them by May 2026.

Heike Möhlig-Zuttermeister, head of the IVD business unit within TÜV SÜD's Medical and Health Services division, said in a statement that the certification "demonstrates the effectiveness of IVDR implementation activities by all the stakeholders involved," including Roche, the EMA, and TÜV SÜD.

TÜV SÜD Product Service GmbH has been designated to issue IVDR certificates since June 2020.

An earlier version of this story inaccurately reported that TÜV Rheinland was a subsidiary of TÜV SÜD. The two companies share similar origins, but are separate entities.