FDA approves Roche’s VENTANA ALK (D5F3) CDx Assay for use on the VENTANA BenchMark ULTRA system
Tucson, AZ, November 7, 2016– Roche (SIX: RO, ROG; OTCQX:RHHBY) announced today that the U.S. Food and Drug Administration (FDA) has approved the VENTANA ALK (D5F3) CDx Assay1 for use on the VENTANA BenchMark ULTRA automated slide stainer. The assay is a companion diagnostic to aid in the identification of ALK-positive lung cancer patients who are eligible for treatment with Pfizer’s FDA-approved therapy XALKORI® (crizotinib).2
The VENTANA ALK (D5F3) CDx Assay was approved in 2012 in countries accepting the CE mark and by the China Food and Drug Administration (CFDA) in 2013. It received FDA Class III approval in June 2015 for use on VENTANA BenchMark XT system. Due to an established presence of the BenchMark ULTRA system in laboratories globally, this latest approval means even more non-small cell lung cancer (NSCLC) patients may benefit from improved treatment options.
“ALK is an important biomarker found in non-small cell lung cancer. Detection and inhibition of this biomarker can help shrink tumors in some ALK-positive patients,” said Ann Costello, Head of Roche Tissue Diagnostics. “The FDA’s approval of the VENTANA ALK CDx Assay on the VENTANA BenchMark ULTRA system underscores our continued commitment to expanding the identification of NSCLC patients who may be eligible for improved treatment options.”
Lung cancer remains the leading cause of cancer deaths with an annual estimated 12.9 percent of all new cancer cases and nearly 1.6 million deaths worldwide. NSCLC accounts for approximately 85 percent of all lung cancer cases.3 During the past three decades, lung cancer has shown the least improvement in survival rates when compared with other cancers.4
1This product is intended for in vitro diagnostic (IVD) use. The VENTANA ALK (D5F3) CDx Assay is designed to identify those patients most likely to respond to treatment with XALKORI (crizotinib), an immunotherapy that is an oral, first-in-class ALK inhibitor.
2XALKORI (crizotinib) Prescribing Information. New York, NY: Pfizer Labs; 2016.
3Ferlay J, Soerjomataram I, Ervik M, et al. GLOBOCAN 2012 v1.0. Cancer Incidence and Mortality Worldwide: IARC CancerBase No. 11. http://globocan.iarc.fr. Published 2013-12-12. Updated 2014-01-09. Accessed 2016-02-08.
4Siegel R, Naishadham D, Jemal A. Cancer Statistics, 2013. CA Cancer J Clin. 2013;63(1):11-30.
About the VENTANA ALK (D5F3) CDx Assay
VENTANA ALK (D5F3) CDx Assay is intended for laboratory use in the detection of the anaplastic lymphoma kinase (ALK) protein in formalin-fixed, paraffin-embedded (FFPE) non-small cell lung carcinoma (NSCLC) tissue stained with the VENTANA BenchMark XT and VENTANA BenchMark ULTRA immunohistochemical (IHC) automated slide stainers. It is indicated as an aid in identifying patients with NSCLC eligible for treatment with XALKORI (crizotinib). For more information, visit ALKihc.com.
For more information on crizotinib, visit the Pfizer website.
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Positive case of lung tissue stained for ALK
with VENTANA ALK (D5F3) CDx Assay
Negative case of lung tissue stained for ALK
with VENTANA ALK (D5F3) CDx Assay
VENTANA BenchMark ULTRA
IHC/ISH staining instrument
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