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Roche Diagnostics Deutschland GmbH Sandhofer Str. 116 68309 Mannheim, Germany http://www.roche.de/
Company logo of Roche Diagnostics Deutschland GmbH
Roche Diagnostics Deutschland GmbH

Roche erhält die CE-Kennzeichnung für den VENTANA FOLR1 (FOLR1-2.1) RxDx Assay

(PresseBox) (Mannheim, )

Der VENTANA® FOLR1 (FOLR1-2.1) RxDx Assay detektiert das Folatrezeptor 1 Protein (FOLR1 oder FRɑ), welches in den meisten Fällen von Ovarialkarzinomen überexprimiert ist. Mit einem klinisch validierten Cutoff dient der Assay als prädiktiver Biomarker für die FOLR1-gezielte Therapie des Ovarialkarzinoms.
Der Test identifiziert Ovarialkarzinom-Patientinnen, die für eine gezielte Behandlung mit Mirvetuximab Soravtansin in Frage kommen können.
Die CE-Markierung folgt auf die Entscheidung des Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) Mitte des Jahres, eine Sonderzulassung für den Test in Deutschland und Österreich zu erteilen.


Roche gab bekannt, dass der VENTANA FOLR1 (FOLR1-2.1) RxDx Assay die CE-Kennzeichnung erhalten hat. Dies ist der erste immunhistochemische
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