Roche has received the CE mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as a companion diagnostic to identify ovarian cancer patients.
The VENTANA FOLR1 Assay is said to be the first immunohistochemistry (IHC) companion diagnostic test available in Europe for identifying epithelial ovarian cancer (EOC) patients.
The test helps determine eligibility for targeted treatment with Elahere (mirvetuximab soravtansine).
Elahere is an antibody-drug conjugate (ADC) therapy developed by AbbVie for FRɑ-positive, platinum-resistant ovarian cancer.
Recently, AbbVie secured European Commission (EC) marketing authorisation for Elahere to treat patients with ovarian cancer.
This latest CE mark follows earlier pre-authorisation of the VENTANA FOLR1 (FOLR1-2.1) test in Germany and Austria. This early approval enabled clinicians and patients in these countries to access the test before the official certification.
Roche Diagnostics pathology lab head Jill German said: “The early exemption approval in Germany and Austria highlighted the urgent need for this test. Now, clinicians across Europe can access a critical tool to quickly identify ovarian cancer patients who may be eligible for targeted therapy.
“By enabling more precise and personalised treatment decisions, we hope this may help improve outcomes for the many women in Europe facing this devastating disease.”
The VENTANA FOLR1 RxDx Assay is a qualitative immunohistochemical test designed to assess folate receptor alpha (FRɑ) in formalin-fixed, paraffin-embedded tissue specimens from EOC, including primary peritoneal and fallopian tube cancers, tissue specimens by light microscopy.
The assay uses the mouse monoclonal anti-FOLR1 clone FOLR1-2.1 and is performed with the OptiView DAB IHC Detection Kit for staining on a BenchMark ULTRA instrument.
The approval of the assay is based on data from the SORAYA and MIRASOL clinical studies.
Both trials included platinum-resistant epithelial ovarian cancer patients who were FRɑ-positive, as determined by the VENTANA FOLR1 assay.
In the single-arm SORAYA trial, 32% of patients showed a partial or complete response to Elahere therapy.
The MIRASOL trial revealed that Elahere significantly improved progression-free survival compared to IC chemotherapy, reducing the risk of tumour progression or death by 35%.
Additionally, Elahere improved overall survival, reducing the risk of death by 33% compared to chemotherapy.
In October, Roche announced that the US Food and Drug Administration (FDA) had approved the VENTANA CLDN18 (43-14A) RxDx Assay for identifying patients with gastric or gastroesophageal junction (GEJ) adenocarcinoma.
