Roche gains CE label expansion for companion diagnostic to identify ALK-positive non-small cell lung cancer patients
Roche (SIX: RO, ROG; OTCQX:RHHBY) today announced that it has obtained a CE mark for the VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody as a companion diagnostic to identify ALK-positive non-small cell lung cancer (NSCLC) patients eligible for treatment with the Novartis drug ZYKADIA (ceritinib). The VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody is the only immunohistochemistry (IHC) test CE marked as a companion diagnostic for ZYKADIA.
"Precise, personalized diagnostics are critical as we continue the fight against non-small cell lung cancer," said Ann Costello, Head of Roche Tissue Diagnostics. "Expanded use of the VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody to identify non-small cell lung cancer patients with an ALK-positive mutation allows us to aid clinicians and their patients in identifying appropriate treatment options."
The VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody is available for use on BenchMark IHC/ISH instruments.
About the VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody
VENTANA anti-ALK (D5F3) Rabbit Monoclonal Primary Antibody (VENTANA anti-ALK (D5F3)) is intended for laboratory use in the detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded non-small cell lung carcinoma (NSCLC) tissue stained with the BenchMark series immunohistochemical automated slide stainers. It is indicated as an aid in identifying patients eligible for treatment with ZYKADIA® (ceritinib) or XALKORI® (crizotinib).
This product should be interpreted by a qualified pathologist in conjunction with histological examination, relevant clinical information and proper controls.
This antibody is intended for in vitro diagnostic (IVD) use.
For more information on ZYKADIA (ceritinib), visit www.novartisoncology.com/news/product-portfolio/zykadia
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VENTANA and BENCHMARK are trademarks of Roche. Other product names and trademarks are the property of their respective owners.
ZYKADIA is a trademark of Novartis.
1Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0. Cancer Incidence and Mortality Worldwide: IARC
2This product is intended for in vitro diagnostic (IVD) use.
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