Roche receives CE Mark for VENTANA FOLR1 (FOLR1-2.1) RxDx Assay as the first IHC-based companion diagnostic to identify ovarian cancer patients eligible for ELAHERE

Rhea-AI Summary

Roche has received CE Mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, the first immunohistochemistry companion diagnostic test in Europe for identifying epithelial ovarian cancer patients eligible for ELAHERE treatment. The test detects folate receptor 1 protein, expressed in about 90% of ovarian carcinomas. This certification follows an early exemption approval in Germany and Austria earlier this year. The test aims to enable more precise treatment decisions for ovarian cancer, which causes 46,232 deaths annually in Europe and is the eighth leading cause of cancer death in women worldwide.

Positive

• First IHC companion diagnostic test approved in Europe for ovarian cancer
• Early market access achieved in Germany and Austria through exemption approval
• Test addresses a significant market with FOLR1 expressed in 90% of ovarian carcinomas

Negative

• None.

Insights

Medical Research Analyst

The CE Mark approval for Roche's VENTANA FOLR1 RxDx Assay represents a significant advancement in precision medicine for ovarian cancer treatment. This companion diagnostic test addresses a critical market need, targeting the FOLR1 protein present in approximately 90% of ovarian carcinomas. The test's ability to identify suitable candidates for ELAHERE therapy enhances treatment precision and potentially improves patient outcomes.

The early exemption approval in Germany and Austria, followed by this broader CE certification, indicates strong regulatory confidence and urgent clinical demand. This positions Roche strategically in the growing companion diagnostics market, particularly important given that ovarian cancer causes 46,232 deaths annually in Europe. The test's role in enabling targeted therapy access could significantly influence treatment protocols and market dynamics in the oncology diagnostics sector.

Market Research Analyst

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 (FOLR1-2.1) RxDx Assay detects the folate receptor 1 protein (FOLR1 or FRɑ), which is over-expressed in most ovarian cancers.
  
  
• The test identifies ovarian cancer patients eligible for targeted treatment with ELAHERE.
  
  
• This certification follows the unprecedented decision by regulators to grant an early exemption approval for the test in Germany and Austria earlier this year.

TUCSON, Ariz., Nov. 18, 2024 /PRNewswire/ -- Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that it has received CE Mark for its VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay. This is the first immunohistochemistry (IHC) companion diagnostic test to be made widely available in Europe to aid in identifying epithelial ovarian cancer (EOC) patients who may be eligible for targeted treatment with ELAHERE® (mirvetuximab soravtansine). ELAHERE is a first-in-class antibody-drug conjugate (ADC) therapy developed by AbbVie for the treatment of FRɑ-positive platinum-resistant ovarian cancer.

This certification follows the news earlier this year that the VENTANA FOLR1 (FOLR1-2.1) test had received pre-authorisation in Germany and Austria. This exceptional decision allowed clinicians and patients in these countries to access the test ahead of the CE Mark certification.

"This certification will allow us to extend the reach of our innovative diagnostic solutions," said Jill German, Head of Pathology Lab at Roche Diagnostics. "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."

Folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FRɑ), is expressed at some level in approximately 90 percent of ovarian carcinomas and serves as a predictive biomarker for FOLR1-targeted therapy for EOC patients.^1,2 The VENTANA FOLR-1 (FOLR1-2.1) test informs clinicians about the likelihood of potential patient benefit from FOLR1 therapy,^3,4 advancing Roche's commitment to personalised healthcare through innovative solutions that help fit the treatment to the individual.

Ovarian cancer is the eighth overall cause for cancer death in women worldwide, representing 4.7% of all cancer deaths in women. It is also one of the deadliest gynaecological cancers worldwide. In 2022, 46,232 women in Europe and 209,596 women worldwide died from ovarian cancer.⁵

The launch of Roche's first IHC companion test for ovarian cancer in CE countries 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 personalised healthcare and deliver novel, high medical value solutions that improve patients' lives.

About the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay
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 (FOLR1-2.1) 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.

The approval is based on the results from the SORAYA⁶ and MIRASOL⁷ clinical studies. Both studies enrolled platinum-resistant epithelial ovarian cancer patients who were FRɑ-positive by the VENTANA FOLR1 (FOLR1-2.1) RxDx Assay. In the single-arm SORAYA trial, 32% of patients demonstrated a partial or complete response to ELAHERE therapy.⁵ In the MIRASOL trial, patients who received ELAHERE demonstrated a significant improvement in progression-free survival by investigator assessment compared with IC chemotherapy, which represented a 35% reduction in the risk of tumour progression or death (HR 0.65, 95% CI, 0.52-0.81). Patients who received ELAHERE also demonstrated a significant improvement in overall survival compared to chemotherapy, which represented a 33% reduction in the risk of death (HR 0.67, 95% CI, 0.50-.0.89).⁷

About Roche 
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 personalised 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 recognising our endeavour 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 fifteenth 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.

All trademarks used or mentioned in this release are protected by law.

References

¹Scaranti, M., Cojocaru, E., Banerjee, S. et al. Exploiting the folate receptor α in oncology. Nat Rev Clin Oncol 17, 349–359 (2020).
²Hilgenbrink A., Low P. Folate receptor-mediated drug targeting: From Therapeutics to diagnostics. Journal of Pharmaceutical Sciences. 2005;94(10): 2135-2146.
³James, Racheal L., et al. "Development of an FRα Companion Diagnostic Immunohistochemical Assay for Mirvetuximab Soravtansine." Archives of Pathology & Laboratory Medicine (2024).
⁴Roche. VENTANA FOLR1 (FOLR-2.1) RxDx Assay. CE Package Insert. 2024.
⁵Bray, Freddie, et al. "Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries." CA: a cancer journal for clinicians 74.3 (2024): 229-263.
⁶Matulonis, Ursula A., et al. "Efficacy and safety of mirvetuximab soravtansine in patients with platinum-resistant ovarian cancer with high folate receptor alpha expression: results from the SORAYA study." Journal of clinical oncology 41.13 (2023): 2436-2445.
⁷Moore, Kathleen N., et al. "Phase III MIRASOL (GOG 3045/ENGOT-Ov55) study: mirvetuximab soravtansine vs. investigator's choice of chemotherapy in platinum-resistant, advanced high-grade epithelial ovarian, primary peritoneal or fallopian tube cancers with high folate receptor-alpha (FRα) expression." J Clin Oncol 41 (2023): abstrLBA5507.

Roche Media Relations
Jo Lynn Garing
Phone: +1 317-363-7286
Email: jo_lynn.garing@roche.com 

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SOURCE Roche

FAQ

What is the purpose of Roche's VENTANA FOLR1 RxDx Assay (RHHBY)?

The VENTANA FOLR1 RxDx Assay is a diagnostic test that identifies ovarian cancer patients who may be eligible for targeted treatment with ELAHERE by detecting folate receptor 1 protein expression.

When did Roche (RHHBY) receive CE Mark for VENTANA FOLR1 Assay?

Roche received CE Mark approval for the VENTANA FOLR1 RxDx Assay on November 18, 2024.

Which countries first approved Roche's VENTANA FOLR1 test before CE Mark?

Germany and Austria granted early exemption approval for the VENTANA FOLR1 test before the CE Mark certification in 2024.