SWITZERLAND – Roche has achieved a significant milestone with the CE Mark approval of its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay.
The VENTANA FOLR1 is the first immunohistochemistry (IHC) companion diagnostic available in Europe to identify patients with epithelial ovarian cancer (EOC) who are eligible for treatment with AbbVie’s ELAHERE (mirvetuximab soravtansine).
This innovative test is specifically designed to identify patients with FRɑ-positive, platinum-resistant ovarian cancer, a condition with limited treatment options and poor prognosis.
The VENTANA FOLR1 test was already made available earlier this year through a pre-authorisation process in Germany and Austria, allowing doctors and patients in those countries to access the test before the CE Mark certification.
This early approval highlighted the urgent need for a diagnostic solution in the fight against ovarian cancer, where treatment options are scarce and often come too late.
“This certification will allow us to extend the reach of our innovative diagnostic solutions,” said Jill German, Head of Pathology Lab at Roche Diagnostics.
Folate receptor 1 (FOLR1), also known as FRɑ, is a protein found in around 90% of ovarian carcinomas.
It serves as a predictive biomarker for targeted therapies, and the VENTANA FOLR1 test helps doctors identify which patients could benefit from FOLR1-targeted treatments.
This development underscores Roche’s commitment to personalized healthcare, providing clinicians with more accurate, tailored treatment options for their patients.
Ovarian cancer remains one of the deadliest cancers for women worldwide, ranking as the eighth leading cause of cancer death.
In Europe alone, 46,232 women died from ovarian cancer in 2022. Given its aggressive nature and difficulty in early detection, the introduction of Roche’s FOLR1 test is a crucial step forward in improving treatment outcomes.
This development strengthens Roche’s market position in both diagnostics and personalized medicine.
As the world’s leading in vitro diagnostics provider, this first-in-class IHC companion diagnostic for ovarian cancer creates a competitive advantage.
The partnership with AbbVie’s ELAHERE therapy establishes a important diagnostic-therapeutic combination that could drive revenue growth in both testing and treatment markets.
The timing and market access strategy, beginning with early exemption in key markets before full CE certification, demonstrates effective market penetration planning.
With ovarian cancer being the eighth leading cause of cancer death in women globally, this test addresses a substantial market need and could significantly impact Roche’s diagnostics division performance.
The VENTANA FOLR1 RxDx Assay is based on results from clinical trials, including the SORAYA and MIRASOL studies.
In the SORAYA trial, 32% of patients treated with ELAHERE showed a partial or complete response, while the MIRASOL trial demonstrated that ELAHERE significantly improved progression-free survival and overall survival compared to chemotherapy.
