GlobalData on MSN6h
Roche secures CE mark for ovarian cancer detection test
Roche has secured CE mark approval for its immunohistochemistry (IHC) companion diagnostic test, VENTANA FOLR1 (FOLR1-2.1) ...
360dx3h
Roche IHC Assay Nabs CE Mark as Companion Diagnostic for Abbvie's Elahere in Ovarian Cancer
The immunohistochemistry test detects the folate receptor 1 protein, which is over-expressed in most ovarian cancers.
Roche's VENTANA FOLR1 (FOLR1-2.1) RxDx Assay Gets CE Mark In Ovarian Cancer Treatment
Swiss drug major Roche Group (RHHBY) announced Monday that it has received CE Mark for its VENTANA FOLR1 (FOLR1-2.1) RxDx Assay, ...
Roche receives CE Mark for Ventana FOLR1 RxDx Assay
Roche (RHHBY) announced that it has received CE Mark for its Ventana FOLR1 RxDx Assay. This is the first immunohistochemistry, or IHC, ...
GlobalData on MSN1mon
Roche’s VENTANA CLDN18 assay gains CE mark
Roche has gained the Conformité Européenne (CE) mark of approval for its VENTANA CLDN18 (43-14A) RxDx assay to identify ...
AbbVie Receives European Commission Approval of ELAHERE® (mirvetuximab soravtansine) for the Treatment of Platinum-Resistant Ovarian Cancer
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 ...
Pharmabiz1mon
Roche’s IHC companion diagnostic test, VENTANA CLDN18 (43-14A) RxDx Assay to identify patients with gastric or GEJ cancer gets CE Mark approval
Roche announced that the VENTANA CLDN18 (43-14A) RxDx Assay is the first immunohistochemistry (IHC) companion diagnostic test to receive CE Mark approval for determining CLDN18 protein expression in ...
Morningstar1mon
Roche Gets FDA Approval for Cancer Diagnostic Test
The diagnostic, called the Ventana CLDN18 (43-14A) RxDx Assay, can help determine the status of Claudin 18 protein expression in tumors of cancer patients, helping inform clinicians about the ...
Monthly Prescribing Reference1mon
Vyloy Approved for Gastric and Gastroesophageal Junction Cancer
In clinical trials, CLDN18.2 positivity was determined by immunohistochemistry on gastric or GEJ tumor tissue specimens with the Ventana CLDN18 (43-14A) RxDx Assay. The Food and Drug ...
Nasdaq1mon
Astellas' VYLOY™ (zolbetuximab-clzb) Approved by U.S. FDA for Treatment of Advanced Gastric and GEJ Cancer
1 The VENTANA CLDN18 (43-14A) RxDx Assay from Roche is an FDA-approved IHC test used to help determine CLDN18.2 status. Testing is available in the U.S. at multiple reference laboratories ...
MarketWatch1mon
Roche Gets FDA Approval for Cancer Diagnostic Test
Roche Holdings said it received Food and Drug Administration approval for its companion diagnostic of gastric and gastroesophageal junction cancer. The diagnostic, called the Ventana CLDN18 (43 ...