Roche Diagnostics U.S. Media Relations
Developed as a predictive biomarker, the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers.
The new test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE.
The test is the latest addition to Roche’s portfolio of companion diagnostics designed to provide critical insights that enable more informed clinical decisions and improved patient outcomes.
Tucson, November 14, 2022 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced U.S. Food and Drug Administration (FDA) approval of the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry (IHC) companion diagnostic test to aid in identifying epithelial ovarian cancer (EOC) patients who are eligible for targeted treatment with ELAHERE™ (mirvetuximab soravtansine-gynx). ELAHERE is a first-in-class antibody-drug conjugate (ADC) therapy developed by ImmunoGen, Inc., approved under FDA’s Accelerated Approval program for the treatment of FRɑ-positive platinum-resistant ovarian cancer.
Folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FRɑ), is expressed at some level in approximately 90% of ovarian carcinomas and serves as a predictive biomarker for FOLR1-targeted therapy for EOC patients.1,2 The new test informs clinicians about the likelihood of potential patient benefit from FOLR1 therapy,3,4 advancing Roche’s commitment to personalized healthcare through innovative solutions that help fit the treatment to the individual.
The approval is based on the results of the SORAYA clinical study.4 In the study, approximately 35% of ovarian cancer patients expressed high levels of FRα (defined as ≥ 75% viable tumor cells with membrane staining at moderate and/or strong intensity levels) and were considered FRα-positive by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. Of the FRα-positive patients, about 32% demonstrated a partial or complete response to ELAHERE therapy.5
Ovarian cancer is the eighth most common cancer in women worldwide and patients often have advanced disease when diagnosed.6 Despite improvements in primary therapy, mortality rates remain high, and 80% percent of patients with advanced EOC will have their disease recur.7,8 The five-year relative survival rate for all stages of invasive EOC is 49%.9
The launch of Roche’s first companion test for ovarian cancer highlights the company’s commitment, as the world’s leading provider of in-vitro diagnostics, to continued innovation and evolution of its products in order to advance personalized healthcare and deliver novel, high-medical-value solutions that improve patients’ lives. For the current list of labs in the U.S. that offer testing, please visit usinfo.roche.com/folr1ihc.
Roche has developed a leading, comprehensive and differentiated cancer immunohistochemical portfolio, with biomarkers that support multiple guidelines for the diagnosis and stratification of cancers. VENTANA FOLR1 (FOLR-2.1) RxDx Assay is a qualitative immunohistochemical assay using mouse monoclonal anti-FOLR1 clone FOLR1-2.1 intended for use in the assessment of folate receptor alpha (FRɑ) in formalin-fixed, paraffin-embedded epithelial ovarian cancer (EOC), including primary peritoneal cancer and primary fallopian tube cancer, tissue specimens by light microscopy. The OptiView DAB IHC Detection Kit is used for staining on a BenchMark ULTRA instrument.
Founded in 1896 in Basel, Switzerland, as one of the first industrial manufacturers of branded medicines, Roche has grown into the world’s largest biotechnology company and the global leader in in-vitro diagnostics. The company pursues scientific excellence to discover and develop medicines and diagnostics for improving and saving the lives of people around the world. We are a pioneer in personalized healthcare and want to further transform how healthcare is delivered to have an even greater impact. To provide the best care for each person we partner with many stakeholders and combine our strengths in Diagnostics and Pharma with data insights from the clinical practice.
In recognizing our endeavor to pursue a long-term perspective in all we do, Roche has been named one of the most sustainable companies in the pharmaceuticals industry by the Dow Jones Sustainability Indices for the thirteenth consecutive year. This distinction also reflects our efforts to improve access to healthcare together with local partners in every country we work.
Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan.
For more information, please visit www.roche.com.
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