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Vysis LSI ALK Break Apart Rearrangement Probes

For In Vitro Diagnostic Use
View Ordering Information
Product Name Quantity Order # Additional Information
Vysis ALK Break Apart FISH Probe Kit IVD 20 assays 06N38-020 Order
Vysis Paraffin Pretreatment IV & Post-Hybridization Wash Buffer Kit IVD 1 Kit 01N31-005 Order
Vysis ProbeChek ALK Negative Control Slides IVD 5 slides 06N38-005 Order
Vysis ProbeChek ALK Positive Control Slides IVD 5 slides 06N38-010 Order

Product Probe Description

Probe Name Probe Location Fluorophore
Vysis LSI ALK 2p23 SpectrumOrange
Vysis LSI ALK 2p23 SpectrumGreen

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) tissue specimens to aid in identifying those patients eligible for treatment with Xalkori® (crizotinib).

Reduce variability with ready-to-use components

  • Premixed, optimized probes
  • ALK positive control slides
  • ALK negative control slides
  • Ready-to-use slide preparation reagents

 

Probe Map

Vysis_LSI_ALK/Probe_Map_LSI_ALK_2p23.gif

Ideogram

Vysis_LSI_ALK/Ideogram_2p23_LSI_ALK.jpg

References

  • Global ALK Availability
  • Kwak EL, Bang YJ, Camidge DR, et al.  Anaplastic lymphoma kinase inhibition in non-small-cell lung cancer.  N Engl J Med. 2010;363(18):1693-1703
  • NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™). Non-Small Cell Lung Cancer (Version 3.2011). ©2011 National Comprehensive Cancer Network, Inc. Available at: NCCN.org. Accessed (March 28, 2011)
  • Shaw AT, Forcione DG, et al. Case 21-2011: A 31-Year-Old Man with ALK-Positive Adenocarcinoma of the Lung. N Engl J Med 2011;365:158-67.
 

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) non-small cell lung cancer (NSCLC) tissue specimens to aid in identifying those patients eligible for treatment with Xalkori® (crizotinib).

Warnings and Limitations

  • 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 only on 10% neutral buffered FFPE human lung tumor tissue. Other types of specimens or fixatives should not be used.
  • 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 signals.

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.

 

 

For In Vitro Diagnostic Use