Deletion Probe

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

IVDR Certification

This probe is IVDR-certified in compliance with the Regulation (EU) 2017/746 on in vitro diagnostic medical devices (IVDR).

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 RB1/DLEU/LAMP consists of a green-labeled probe hybridizing to the RB1 gene region at 13q14.2, an orange-labeled probe hybridizing to the DLEU1/MIR15A/MIR16-1 gene region at 13q14.2 including D13S319 and an aqua-labeled probe hybridizing to the LAMP1 gene region at 13q34.

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

In chronic lymphocytic leukemia (CLL), deletion at 13q14 with at least one allele occurs in more than 50% of cases. A minimal deleted region (MDR) of 350kb in size has been identified and is usually seen as an indicator for good prognosis. However, recent studies using high resolution arrays have shown, that the 13q14 deletion can vary in size and, if it is including the RB1 gene, may lead to a change in the prognosis of CLL patients. RB1 is a critical regulator of cell cycle progression and genomic stability and its loss could explain this change of interpretation in CLL.

Deletions of chromosome 13q14 have been reported in a variety of human tumors, including other types of lymphoid tumors and myeloid leukemias, as well as prostate, head and neck, and non-small-cell lung cancers.

Clinical Applications

  • Chronic Lymphocytic Leukemia (CLL)
  • Multiple Myeloma and Plasma Cell Neoplasms (MM)
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XL RB1/DLEU/LAMP hybridized to lymphocytes. Two normal interphases are shown.

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Expected Patterns

Expected Pattern 1

Normal Cell:
Two Blue (2B), two green (2G) and two orange (2O) signals.

Expected Pattern 2

Aberrant Cell:
Two blue (2B), two green (2G) and one orange (1O) signal resulting from the loss of one orange signal.

Expected Pattern 3

Aberrant Cell:
Two blue (2B), one green (1G) and one orange (1O) signal resulting from the loss of one green and one orange signal.

Expected Pattern 4

Aberrant Cell:
One blue (1B), one green (1G) and one orange (1O) signal.

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  • Doehner et al (2000) N Engl J Med 34:1910-1916
  • Ouillette et al (2008) Cancer Res 68:1012-1021
  • Dal Bo et al (2011) Genes Chromosomes Cancer 50:633-643



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