Roche's VENTANA FOLR1 Assay Gets CE Mark for Ovarian Cancer Diagnosis

Roche has announced the receipt of the CE Mark certification for its VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay. This diagnostic test is the first immunohistochemistry (IHC) companion diagnostic test available in Europe, designed to identify epithelial ovarian cancer (EOC) patients suitable for targeted treatment with ELAHERE® (mirvetuximab soravtansine). ELAHERE is developed by AbbVie for treating FRɑ-positive platinum-resistant ovarian cancer.

Following a unique regulatory decision earlier in the year, the test had already been made accessible in Germany and Austria before receiving CE Mark certification. This early exemption approval highlighted the urgent need for the test, enabling clinicians and patients in these countries to benefit from it sooner.

Jill German, Head of Pathology Lab at Roche Diagnostics, expressed that the CE Mark certification will extend the availability of Roche’s diagnostic solutions across Europe. She emphasized that this development will provide clinicians with a vital tool to quickly identify ovarian cancer patients who might benefit from targeted therapy, potentially improving treatment outcomes for many women affected by this severe disease.

Folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FRɑ), is present in about 90 percent of ovarian carcinomas. It is a predictive biomarker for FOLR1-targeted therapy in EOC patients. The VENTANA FOLR-1 (FOLR1-2.1) test helps clinicians determine the likelihood of patient benefit from FOLR1 therapy, advancing Roche's dedication to personalized healthcare by aligning treatment with individual patient profiles.

Ovarian cancer ranks as the eighth leading cause of cancer death among women globally, accounting for 4.7% of all female cancer deaths. It is also one of the most lethal gynecological cancers. In 2022, ovarian cancer claimed the lives of 46,232 women in Europe and 209,596 women worldwide.

Roche's launch of its first IHC companion test for ovarian cancer in CE countries underscores the company's ongoing innovation and commitment to personalized healthcare. As a leading provider of in vitro diagnostics, Roche aims to deliver high medical value solutions that improve patients' lives.

The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is a qualitative immunohistochemical assay. It uses mouse monoclonal anti-FOLR1 clone FOLR1-2.1 to assess folate receptor alpha (FRɑ) in formalin-fixed, paraffin-embedded EOC tissues, including primary peritoneal and primary fallopian tube cancers. The OptiView DAB IHC Detection Kit is used for staining on the BenchMark ULTRA instrument.

The approval of this test is based on clinical results from the SORAYA and MIRASOL studies. In the SORAYA trial, 32% of patients showed a partial or complete response to ELAHERE therapy. In the MIRASOL trial, patients treated with ELAHERE exhibited a significant improvement in progression-free survival compared to those receiving chemotherapy, with a 35% reduction in the risk of tumor progression or death. Additionally, ELAHERE treatment resulted in a 33% reduction in the risk of death compared to chemotherapy.

Founded in 1896 in Basel, Switzerland, Roche has evolved into the world's largest biotechnology company and a global leader in in-vitro diagnostics. The company is committed to personalized healthcare, striving to transform healthcare delivery to enhance patient outcomes. With a focus on scientific excellence, Roche collaborates with various stakeholders to provide the best care through its combined strengths in Diagnostics and Pharma, supported by data insights from clinical practice.