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.

Please use the switch to change to the IVDR product.

IVDDIVDRDiscover all IVDR-certified products

Product Description


XL CDKN2A consists of an orange-labeled probe hybridizing to the CDKN2A (p16)/CDKN2B (p15) gene region at 9p21 and a green-labeled probe hybridizing to the centromere of chromosome 9.

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.

Need assistance or a quote?

Clinical Details

Acute lymphoblastic leukemia (ALL) is the most common childhood cancer type. T-cell acute lymphoblastic leukemia (T-ALL) is an aggressive and quickly progressing type of ALL affecting T-lymphocytes. Inactivation of the tumor suppressor genes CDKN2A/2B, located at chromosomal region 9p21, is a significant event in the development of T-ALL and other cancer types. Principally, loss of function might happen by deletion, methylation of promotor regions or mutations, whereas deletion of chromosomal region 9p21 seems to be the predominant mechanism. CDKN2A/2B deletions can be detected in about 60% of pediatric and about 50% of adult T-ALL cases. Most deletions are within the resolution of the FISH technique. Genetic alterations of the 9p21 locus result in loss of regulation of the cell cycle which is critical to cancer development.

Clinical Applications

  • Acute Lymphoblastic Leukemia (ALL)
Need assistance or a quote?



XL CDKN2A hybridized to bone marrow cells. Two normal cells and several cells with two green signals are shown indicating a homozygous deletion of the CDKN2A.

Need assistance or a quote?

Expected Patterns

Expected Pattern 1

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

Expected Pattern 2

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

Expected Pattern 3

Aberrant Cell (typical results):
Two green (2G) and no orange
(no O) signal resulting from homozygous deletion of the locus covered by the orange probe.

Need assistance or a quote?


  • Novara et al (2009) Human Genet 126:511-520
  • Sulong et al (2009) Blood 113:100-107
  • Girardi et al (2017) Blood 129:1113-1123



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