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Lung Cancer

VYSIS ALK BREAK APART FISH PROBE KIT

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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.

Vysis ALK Break Apart FISH Probe Kit Package Insert (Automated with VP 2000)

For Information Only - Not a Controlled Copy

Reduce variability with ready-to-use components 

Vysis ALK Break Apart FISH Probe Kit contains:

  • Vysis LSI ALK Dual Color Break Apart FISH Probe, SpectrumOrange (50 ng/10 μL) and SpectrumGreen (200 ng/10 μL) fluorophore-labeled DNA probes in hybridization buffer containing dextran sulfate, formamide, and SSC with blocking DNA.
  • DAPI I Counterstain, 1 μg/mL, DAPI (4′,6-diamidino-2-phenylindole•2HCl) in phenylenediamine dihydrochloride, glycerol, and phosphate buffered saline mixture.

 


INTENDED USE

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) tissue specimens from 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), ALUNBRIG® (brigatinib), and ENSACOVE® (ensartinib) in accordance with the approved therapeutic product labeling.

 

LIMITATIONS OF THE PROCEDURE
 

For In Vitro Diagnostic Use Only

  • Optimal performance of this test requires appropriate specimen handling, preparation, and storage as described in the package insert.
  • The Vysis ALK Break Apart FISH Probe Kit has been optimized only for identifying and quantifying rearrangements of the ALK gene from formalin-fixed, paraffin-embedded human NSCLC tissue specimens. The assay should be performed only on 10% neutral buffered formalin FFPE human lung tumor tissue. Other types of specimens or fixatives should not be used, as described in the package insert.
  • The performance of the Vysis ALK Break Apart FISH Probe Kit was established using the procedures provided in the package insert only. Modifications to these procedures may alter the performance of the assay.
  • The clinical interpretation of any test results should be evaluated within the context of the patient’s medical history and other diagnostic laboratory test results.
  • FISH assay results may not be informative if the specimen quality and/or specimen slide preparation is inadequate.
  • Technologists performing the FISH signal enumeration must be capable of visually distinguishing between the orange, green, and yellow signals.

 For Prescription Use Only

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