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XL MYC BA triple-color

Break Apart Probe - Triple Color

Order Number
D-6030-100-TC
Package Size
100 µl (10 Tests)
Labels
   
Chromosome
8
Regulatory Status
IVDR

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR). For organizational reasons, we currently provide only the IVDD product.

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Intended Purpose

The XL MYC BA triple-color break-apart probe is a qualitative, non-automated test for the detection of MYC-rearrangements at 8q24.21 by fluorescence in situ hybridization (FISH). The probe design also allows differentiation of the location of the breakpoint. The product is intended as a diagnostic aid and assists in disease monitoring. The test population consists of patients with confirmed or suspected chronic lymphocytic leukemia (CLL), multiple myeloma (MM) and non-Hodgkin lymphomas (NHL). Hybridization is to be performed on methanol/acetic-acid fixed cells derived from bone marrow or peripheral blood for CLL, on methanol/acetic-acid fixed plasma cells for MM and on sections of formalin-fixed paraffin-embedded (FFPE) tumor tissue specimens or methanol/acetic-acid fixed cells derived from involved lymph node, involved bone marrow or other involved tissue for NHL.

Product Description

The XL MYC BA triple-color break-apart probe consists of an orange-labeled probe hybridizing proximal to the MYC gene region at 8q24.21, an aqua-labeled probe hybridizing to the MYC gene region at 8q24.21 and a green-labeled probe hybridizing distal to the MYC gene region at 8q24.21.

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Images

XL MYC BA triple-color

XL MYC BA triple-color hybridized to lymphocytes. One nucleus shows the normal two green-orange-blue signals, the other nucleus shows a separated green signal indicating a break distal to the MYC gene region.

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Expected Patterns

Expected Pattern 1

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

Expected Pattern 2

Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1GOB), one green-blue colocalization/fusion (1GB) and one separate orange (1O) signal resulting from a chromosome break in the respective locus.

Expected Pattern 3

Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1GOB), one one separate green (1G) and one orange-blue colocalization/fusion (1OB) signal resulting from a chromosome break in the respective locus.

Expected Pattern 4

Aberrant Cell (typical results):
One green-orange-blue colocalization/fusion signal (1GOB), one green-blue colocalization/fusion (1GB) and one orange-blue colocalization/fusion (1OB) signal resulting from a chromosome break in therespective locus.

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Downloads

Performance Data (English)Probes Catalog

Certificate of Analysis (CoA)

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News

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