Roche has secured CE mark approval for its immunohistochemistry (IHC) companion diagnostic test, VENTANA FOLR1 (FOLR1-2.1) ...

Swiss drug major Roche Group (RHHBY) announced Monday that it has received CE Mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, ...

Roche (RHHBY) announced that it has received CE Mark for its Ventana FOLR1 RxDx Assay. This is the first immunohistochemistry, or IHC, ...

The immunohistochemistry test detects the folate receptor 1 protein, which is over-expressed in most ovarian cancers.

AbbVie receives European marketing approval for Elahere for the treatment of platinum-resistant ovarian cancer: North Chicago, Illinois Tuesday, November 19, 2024, 10:00 Hrs [IST] ...

AbbVie has announced the European Commission (EC) has granted marketing authorization for ELAHERE (mirvetuximab soravtansine) ...

AbbVie (NYSE: ABBV) today announced the European Commission (EC) granted marketing authorization for ELAHERE® (mirvetuximab soravtansine) for the treatment of adult patients with folate receptor-alpha ...

RxDx Assay (Roche). Both the SPOTLIGHT study (Vyloy plus the combination of mFOLFOX6 chemotherapy regimen of oxaliplatin, leucovorin, and fluorouracil versus placebo plus mFOLFOX6) and the GLOW ...

The FDA also approved the VENTANA CLDN18 (43-14A) RxDx Assay, a test to detect CLDN18.2-positive tumors and confirm eligibility for the new treatment. The approval was based on results of two ...

This is the first US approval for VYLOY, a therapy targeting claudin (CLDN)-18.2-positive tumours identified through an FDA-approved diagnostic assay, Roche's VENTANA CLDN18 (43-14A) RxDx assay.

Alongside the drug approval, the FDA also okayed the Ventana CLDN18 (43-14A) RxDx Assay (Ventana Medical Systems, Inc. and Roche Diagnostics) to identify claudin 18.2–positive tumors.