Break Apart Probe

Order Number
Package Size
100 µl (10 Tests)
Regulatory Status

IVDR Certification

MetaSystems Probes has already certified a large part of its portfolio, according to IVDR. For organizational reasons, we currently provide only the IVDD product.

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Product Description


XL ALK BA consists of an orange-labeled probe hybridizing to a region within the ALK gene at 2p23 and a green-labeled probe hybridizing distal to the ALK gene region at 2p23.

Probe maps are created in accordance with the intended purpose of the product. Solid colored bars do not necessarily indicate that the probe fully covers the indicated genomic region. Therefore, caution is advised when interpreting results generated through off-label use. Probe map details based on UCSC Genome Browser GRCh37/hg19. Map components not to scale. Further information is available on request.

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Clinical Details

The EML4/ALK fusion gene is responsible for approximately 3-5% of non-small-cell lung cancer (NSCLC). The vast majority of cases are adenocarcinomas. Two other fusion partners of ALK have been reported in lung cancer - TFG and KIF5B. Up to 12 other translocation partners have been described in anaplastic large-cell lymphomas (ALCL), renal cancer, esophageal squamous cell, colon, and breast carcinoma. Anaplastic lymphoma kinase (ALK) is a receptor tyrosine kinase which was discovered in anaplastic large-cell lymphoma (ALCL).
The formation of a fusion protein with a partner through chromosomal translocations is the most common mechanism of ALK overexpression and ALK kinase domain activation. The ALK inhibitor crizotinib has increased the significance of detecting ALK rearrangements in lung cancer and ALCL.

Clinical Applications

  • Solid Tumors
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XL ALK BA hybridized on lung cancer tissue. Separated green and orange signals indicate an ALK rearrangement.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two green-orange colocalization/fusion signals (2GO).

Expected Pattern 2

Aberrant Cell (typical results):
One green-orange colocalization/fusion signal (1GO), one separate green (1G) and orange (1O) signal each resulting from a chromosome break in the relevant locus.

Expected Pattern 3

Aberrant Cell (typical results):
Two green (2G) and one orange (1O) signal resulting from loss of one orange signal.

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  • Kutok et al (2002) J Clin Oncol 20:3691-3702
  • Perner et al (2008) Neoplasia 10:298-302
  • Shaw et al (2009) J Clin Oncol 27:4247-4253



IVDR Certification

MetaSystems Probes has received IVDR certification for our initial 26 fluorescence in situ hybridization (FISH) probes from the notified body, BSI. Achieving this milestone was not without its challenges, and we are delighted to have accomplished IVDR certification for this probe set at an early stage.

IVDR Certification