November 07, 2017
Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced it has obtained US Food and Drug Administration (FDA) approval for the VENTANA ALK (D5F3) CDx Assay as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Roche medicine ALECENSA® (alectinib). The VENTANA ALK (D5F3) CDx Assay is the only test FDA-approved as a companion diagnostic for ALECENSA.
The VENTANA ALK (D5F3) CDx Assay has been shown in studies to identify more patients that will benefit from an anti-ALK target therapy than fluorescent in situ hybridization (FISH) testing.3,4,5,6 The VENTANA ALK (D5F3) CDx Assay is available for use on the Roche BenchMark XT or BenchMark ULTRA IHC/ISH slide staining systems.7
About the VENTANA ALK (D5F3) CDx Assay
VENTANA ALK (D5F3) CDx Assay is intended for the qualitative detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with a BenchMark XT or BenchMark ULTRA automated staining instrument. It is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib), ZYKADIA® (ceritinib) or ALECENSA® (alectinib).
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.
This product is intended for in vitro diagnostic (IVD) use. For more information, visit ALKIHC.com.
For more information on ALECENSA (alectinib), visit www.alecensa.com.
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The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2016 employed more than 94,000 people worldwide. In 2016, Roche invested CHF 9.9 billion in R&D and posted sales of CHF 50.6 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.
VENTANA and BENCHMARK are trademarks of Roche. Other product names and trademarks are the property of their respective owners.