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:

• Premixed probes
• ALK positive control slides
• ALK negative control slides
• Ready-to-use slide preparation reagents
• Manual and Automation Options

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.

View buffer kit contents and storage specifications

NCCN™ Guidelines Version 4.2020 for Non-Small Cell Lung Cancer¹

• Recommend that patients receive routing molecular biomarker testing forALK gene rearrangements along with EGFR, BRAF and c-MET exon 14 skipping mutation testing, and ROS1 and RET gene rearrangements testing for predictive assessment of the following NSCLC histological subtypes: adenocarcinomas, large cell carcinomas, and NOS (not otherwise specified)
• Consider that patients receive molecular biomarker testing for ALK gene rearrangements, along with EFGR, BRAF and c-MET exon 14 skipping mutation testing, and ROS 1 and RET gene rearrangements testing for predictive assessment of NSCLC patients with a squamous histological subtype if: they are never smokers, had small biopsy speciments used for testing, or a mixed histology was reported, or in samples in which an adenocarcinoma component cannot be excluded.
• States that a molecular diagnostic test that uses fluorescence in situ hybridization (FISH) has been approved by the FDA for detecting ALK fusions, and that FISH break-apart probe methodology was the first methodology deployed widely, to determine the presence of ALK rearrangement , which is associated with responsiveness of ALK TKIs. 

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:

• Identifying any ALK gene rearrangements with multiple  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 (approved in 2011)
• Detection of ALK-positive NSCLC is necessary for selection of patients for treatment with XALKORI^® (crizotinib) and ALUBRIG^® (brigatinib) 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 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 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.

References

1. The NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines™) Non-Small Cell Lung Cancer (version 4.2030) Available at http://www.nccn.org