Switzerland-based Roche has secured the US Food and Drug Administration (FDA) approval for its VENTANA FOLR1 (FOLR1-2.1) RxDx assay.

The FOLR-2.1 assay is a qualitative immunohistochemical (IHC) assay, intended for the evaluation of Folate receptor 1 protein (FOLR1), also known as folate receptor alpha (FRɑ).

It is indicated as an immunohistochemistry (IHC) companion diagnostic to help identify epithelial ovarian cancer (EOC) patients eligible for treatment with ELAHERE.

ELAHERE (mirvetuximab soravtansine-gynx) is an antibody-drug conjugate (ADC) therapy developed by US-based biotechnology company ImmunoGen.

Along with FOLR1-2.1 assay, the drug is also approved by the FDA to treat FRɑ-positive platinum-resistant ovarian cancer, under its Accelerated Approval programme.

FRɑ is expressed in around 90% of ovarian carcinomas and serves as a predictive biomarker for FOLR1-targeted therapy.

The FOLR1-2.1 assay informs the clinicians about potential patient benefits from FOLR1 therapy, said Roche.

Roche Diagnostics pathology lab head Jill German said: “We’re proud to expand our women’s health and oncology portfolios through the addition of the first companion diagnostic IHC test for ovarian cancer.

“This test will enable clinicians to make more informed treatment decisions for patients with ovarian cancer by quickly determining whether they qualify for ELAHERE therapy, potentially improving their outcomes.”

The FDA approval is based on the results from the single-arm SORAYA clinical study in 106 patients with platinum-resistant ovarian cancer.

In the study, approximately 35% of ovarian cancer patients expressed high levels of FRα and were considered FRα-positive by the FOLR1-2.1 RxDx Assay.

Among all the FRα-positive patients in the study, around 32% showed a partial or complete response to ELAHERE therapy.

Roche said that its FOLR1-2.1 RxDx Assay is the first companion test for ovarian cancer.

Earlier this month, Roche created a new brand for its Covid-19 At-Home Test, dubbed Pilot COVID-19 At-Home Test, offered as an over-the-counter test by Roche Diagnostics.