Vysis ALK Break Apart FISH Probe Kit

Reduce variability with ready-to-use components 

Vysis ALK Break Apart FISH Probe Kit features:

• Premixed, optimized probes
• ALK positive control slides
• ALK negative control slides
• Ready-to-use slide preparation reagents
• Manual and Automation Options
• Approved for use on the BioView imaging system¹

NCCN™ Guidelines Version 2.2017 for Non-Small Cell Lung Cancer²

• Recommend ALK rearrangement testing concurrently with EGFR mutation testing for diagnosing the following NSCLC histological subtypes: adenocarcinomas, large cell carcinomas, and NOS (not otherwise specified)
• Consider ALK rearrangement and EGFR mutation testing in patients with mixed squamous histology if:  they are never smokers, small biopsy specimens were used for testing, or mixed histology was reported.
• States that a molecular diagnostic test that uses fluorescence in situ hybridization (FISH) is approved by the FDA to determine which patients with NSCLC are positive for ALK rearrangements, and is a prerequisite before crizotinib therapy. 

Early FISH testing at diagnosis can determine appropriate ALK-directed therapy 

Unlike IHC which is highly subjective and RT/PCR which misses variants, the Vysis ALK test using break-apart FISH technology offers the benefits of:

• Identifying ALK gene rearrangements with fusion partners, including but not restricted to: EML4, TFG, and KIF5B
• Reducing false negative results, which provides confidence that patients are correctly identified and aiding pathologists and oncologists in their goal to diagnose and appropriately manage their NSCLC patients

Personalized Medicine Advances

• The first companion diagnostic for a novel subclass of non-small cell lung cancer patients
• Detection of ALK-positive NSCLC is necessary for selection of patients for treatment with XALKORI^® (crizotinib)
• Abbott announced the simultaneous approval of Pfizer's XALKORI^® (crizotinib) and Abbott's Vysis ALK FISH Probe Kit  

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). The test is for prescription use only.

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 these instructions for use. 
• 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 cancer 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 this 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. 

References

1. http://www.accessdata.fda.gov/cdrh_docs/reviews/k130775.pdf
2. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Non-Small Cell Lung Cancer (version 2.2017) ^©2016 National Comprehensive Cancer Network, Inc. Available at http://www.nccn.org