For In Vitro Diagnostic Use
The Vysis ALK Break Apart FISH Probe Kit detects rearrangements involving the ALK gene via FISH technology in non-small cell lung cancer tissue specimens.
For Information Only - Not a Controlled Copy
The Vysis ALK Break Apart FISH Probe Kit is a qualitative test to detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) patients.
INDICATION FOR USE
The Vysis ALK Break Apart FISH Probe Kit is indicated as an aid in identifying patients eligible for treatment with XALKORI® (crizotinib) and ALUNBRIG® (brigatinib) in accordance with the approved therapeutic product labeling.
Reduce variability with ready-to-use components
Vysis ALK Break Apart FISH Probe Kit features:
Vysis Paraffin Pretreatment IV & Post-Hybridization Wash Buffer Kit
The Vysis Paraffin Pretreatment IV & Post-Hybridization Wash Buffer Kit consists of ready-to-use pretreatment reagents, specially formulated for use in formalin-fixed paraffin embedded (FFPE) lung tissue, but may be applicable in other tissue types. The recommended pretreatment protocol using reagents and protease included in the kit makes nuclear target DNA in the FFPE tissue sections accessible for hybridization with FISH probes.
NCCN™ Guidelines Version 4.2020 for Non-Small Cell Lung Cancer1
Early FISH testing at diagnosis can determine appropriate ALK-directed therapy
Unlike IHC which can be subjective and some NGS and RT/PCR assays which can miss variants, the Vysis ALK test using break-apart FISH technology offers the benefits of:
Personalized Medicine Advances
LIMITATIONS OF THE PROCEDURE
CAUTION: United States Federal law restricts this device to sale and distribution to or on the order of a physician or to a clinical laboratory; and use is restricted to, by, or on the order of a physician.
Vysis Paraffin Pretreatment IV & Post-Hybridization Wash Buffer Kit Contents
All components contained in the Paraffin Pretreatment Reagent Kit IV may be stored at 2 to 8°C except Protease IV, which must be stored at -20°C (± 10°C) upon arrival.
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