Roche Obtains CE Mark for Ventana PD-L1 Assay as CDx for Libtayo


SOFTWARE MD/IVD NEWS October 5, 2022

Roche announced on Friday that the Ventana PD-L1 (SP263) test has been CE marked for use in patients with lung cancer who are taking Regeneron’s Libtayo (cemiplimab).

The goal of the test is to identify non-small cell lung cancer (NSCLC) patients who would be qualified for treatment with Libtayo, a PD-1 inhibitor monotherapy.

According to a release from Roche, the assay finds the programmed death ligand-1 protein, whose expression on immune and tumor cells has been linked to the effectiveness of PD-L1 or PD-1 immunotherapy treatments. The Benchmark Ultra device from Roche is used for the test.

The head of Roche Diagnostics’ pathology lab, Jill German, said in a statement, “With our companion diagnostics, we can help ensure each patient gets the most suitable targeted treatment.” The immunotherapy Libtayo is now available to eligible patients with advanced lung cancer as a first-line treatment thanks to its approval.

The test’s CE label expansion for usage in NSCLC patients to establish eligibility for Roche’s immune checkpoint inhibitor Tecentriq was granted last month (atezolizumab).

According EU IVDR 2017/746 a Companion Diagnostic is “a device which is essential for the safe and effective use of a corresponding medicinal product to:

(a) identify, before and/or during treatment, patients who are most likely to benefit from the corresponding medicinal product; or

(b) identify, before and/or during treatment, patients likely to be at increased risk of serious adverse reactions as a result of treatment with the corresponding medicinal product;”

Additionally, the notified body shall, for companion diagnostics, consult a competent authority designated by Member States in accordance with Directive 2001/83/EC of the European Parliament and of the Council (1) or the EMA, as applicable, in accordance with the procedure outlined in Section 5.2 of Annex IX. The Guidance on the procedural aspects for the consultation to the European Medicines Agency by a notified body on companion diagnostics () for CDx Consultation is available for manufacturers.

MDT specializes in EU MDR and IVDR regulatory consultancy to assist manufacturers in meeting the requirements for placing medical devices on the EU market.


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