VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

Driving Diagnostic Certainty for life-changing decisions in Ovarian Cancer

The VENTANA FOLR1 (FOLR1-2.1) RxDx Assay is a Health Canada-Approved, predictive assay and the first IHC companion diagnostic for determining folate receptor alpha (FR α ) protein expression in epithelial ovarian cancer (EOC) patients.

This assay is indicated as an aid in identifying EOC patients who may be eligible for treatment with ELAHERE (mirvetuximab soravtansine)

Fulfilling an unmet medical need

1. Ferlay, J., Ervik, M., Lam, F., Laversanne, M., Colombet, M., Mery, L., Piñeros, M., Znaor, A., Soerjomataram, I., & Bray, F. (2024). Global Cancer Observatory: CancerToday. International Agency for Research on Cancer. Available from https://gco.iarc.who.int/today

2. Ovarian Cancer Canada. (2023). 2023 Pre-budget submission. Ovarian Cancer Canada. https://ovariancanada.org/wp-content/uploads/2023/01/Ovarian-Cancer-Canada-2023-Pre-budget-submission-FINAL.pdf

Folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FRα), is over-expressed in most ovarian carcinomas and serves as a predictive biomarker for FOLR1-targeted therapy for EOC patients. EOC patients with ≥ 75% TC staining with 2+/3+ intensity may be eligible for treatment with ELAHERE®.

The SORAYA study was a single-arm study that investigated the efficacy of ELAHERE (mirvetuximab soravtansine)1in patients with FRα (FOLR1) positive, platinum-resistant Epithelial Ovarian Cancer (EOC). The study confirmed significant clinical benefit in patients with high FOLR1 expression.

The MIRASOL study was a Phase III, double-arm study designed to confirm the results from the SORAYA study. The study demonstrated that patients who received ELAHERE experienced a 33% reduction in death compared to chemotherapy

Self-paced digital training program that will include:

●Biology and background on the assay

●Guided interpretation of the assay

●Interactive mini-test on scoring sample cases