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SALSA MLPA Probemix P335 ALL-IKZF1

SALSA® MLPA® Probemix P335 ALL-IKZF1 detects copy number variations in the IKZF1, EBF1, CDKN2A/B, PAX5, ETV6, BTG1 and RB1 genes and in the PAR1 region.

Specifications

Contents: 57 MLPA probes, including 8 probes for IKZF1 covering all 8 exons, 7 probes for PAX5, 6 for ETV6, 5 for RB1, 4 for BTG1 and downstream region, 4 for EBF1, 3 for the CDKN2A/CDKN2B region, and 5 for the Xp22.33/Yp11.32 region including PAR1.

Tissue: genomic DNA isolated from human peripheral whole blood or bone marrow.

Application: acute lymphoblastic leukemia (ALL).

CE-marked and registered for in vitro diagnostic (IVD) use in selected territories.

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List Prices Documentation

Key related products

SALSA digitalMLPA Probemix D007 Acute Lymphoblastic Leukemia

DigitalMLPA probemix that contains probes for 52 target genes and three chromosomal regions associated with ALL, including 16 probes for IKZF1.

SALSA MLPA Probemix ME024 9p21 CDKN2A/2B region

Contains probes for the 9p21 region, including CDKN2A and CDKN2B genes for detection of both copy number and methylation status.

SALSA MLPA Probemix P018 SHOX

Contains probes for the SHOX gene and Xp22 regions.

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Intended purpose

The SALSA MLPA Probemix P335 ALL-IKZF1 is an in vitro diagnostic (IVD) or a research use only (RUO) semi-quantitative assay for the detection of deletions of the IKZF1 gene for stratification of patients with acute lymphoblastic leukemia (ALL) into prognostic subgroups. The SALSA MLPA Probemix P335 ALL-IKZF1 is a RUO assay2 for the detection of deletions or duplications in B-cell differentiation and cell cycle control genes (EBF1, CDKN2A/B, PAX5, ETV6, BTG1 and RB1) and in the PAR1 region. This assay is for use on genomic DNA isolated from human peripheral whole blood and bone marrow specimens.

Note that the clinical relevance of some genes in the P335 ALL-IKZF1 probemix is not yet fully established. Therefore, the CE mark for diagnostic use only applies to the IKZF1 gene, and all other genes in the probemix are meant to be used in a research setting only.

For the full intended purpose, see the product description.

Clinical background

The overall incidence rate of ALL amounts to 1.6 in 100,000 per year (Malard and Mohty 2020). The peak incidence lies in childhood at an age of less than 5 years; thereafter, the incidence rate declines continually until the age of 50 years. After that, incidence slightly rises a second time. In patients over 50 years it rises a second time and reaches another peak at the age of over 80 years). There is a slight predominance of males (1.2:1). B-cell ALL accounts for 75% of all cases of ALL and T-cell ALL accounts for the remaining 25% of cases (https://www.lls.org/leukemia/acute-lymphoblastic-leukemia/diagnosis/all-subtypes).

Partial or complete deletions of the IKZF1 (IKAROS family zinc finger 1) gene are frequently detected in ALL cases (Mullighan et al. 2008), especially in those patients who also carry the BCR-ABL1 gene fusion (Philadelphia chromosome). IKZF1 deletions can be identified in approximately 70% of the children with Philadelphia chromosome-positive (Ph+) ALL (2-4% of all paediatric ALL cases), in 10-15% of Philadelphia chromosome-negative (Ph−) paediatric ALL, and in 40% of adult B-cell precursor ALL cases (Bernt and Hunger 2014; Lejman et al. 2022; van der Sligte et al. 2015). Deletion of IKZF1 is associated with a poor prognosis in B-ALL patients (Mullighan et al. 2009a) and a higher chance of relapse (Kuiper et al. 2010).

Several other (partial) gene deletions and duplications, such as in PAX5, ETV6, RB1, BTG1, EBF1 and CDKN2A/2B, have also been described in ALL patients. Prognostic profiles combining these aberrations, such as the IKZF1plus profile (IKZF1 deletions that co-occur with deletions in CDKN2A, CDKN2B, PAX or PAR1 in the absence of ERG deletion; Stanulla et al. 2018), have been described in recent years. See Table 2 for more information on all genes and regions covered in this probemix.

Regulatory status

SALSA MLPA Probemix P335 ALL-IKZF1 is CE-marked for in vitro diagnostic (IVD) use. This assay has also been registered for IVD use in Colombia, Costa Rica and Israel.

This assay is for research use only (RUO) in all other territories.

Product documentation

Version C2

Other versions

Contact us for earlier versions.

List prices

Product

Item no.
Description
Technology
Price
P335-025R
SALSA MLPA Probemix P335 ALL-IKZF1 – 25 rxn
MLPA
€ 281.00
P335-050R
SALSA MLPA Probemix P335 ALL-IKZF1 – 50 rxn
MLPA
€ 550.00
P335-100R
SALSA MLPA Probemix P335 ALL-IKZF1 – 100 rxn
MLPA
€ 1075.00

Required reagents

A general SALSA MLPA Reagent Kit is required for MLPA experiments (to be ordered separately).

Item no.
Description
Technology
Price
EK1-FAM
SALSA MLPA Reagent Kit – 100 rxn – FAM (6 vials)
MLPA MS-MLPA
€ 341.00
EK1-Cy5
SALSA MLPA Reagent Kit – 100 rxn – Cy5 (6 vials)
MLPA MS-MLPA
€ 341.00
EK5-FAM
SALSA MLPA Reagent Kit – 500 rxn – FAM (5×6 vials)
MLPA MS-MLPA
€ 1571.00
EK5-Cy5
SALSA MLPA Reagent Kit – 500 rxn – Cy5 (5×6 vials)
MLPA MS-MLPA
€ 1571.00
EK20-FAM
SALSA MLPA Reagent Kit – 2000 rxn – FAM (5×6 vials)
MLPA MS-MLPA
€ 6037.00
How to Order

Positive samples

Inclusion of a positive sample is usually not required, but can be useful for the analysis of your experiments. MRC Holland has very limited access to positive samples and cannot supply such samples. We recommend using positive samples from your own collection. Alternatively, you can use positive samples from an online biorepository, such as the Coriell Institute.

See this support article for commercially available positive samples that have been tested with this product.

Resources

General resources

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CE

CE-marked products are for In Vitro Diagnostic (IVD) use only in EU (candidate) member states and members of the European Free Trade Association (EFTA), and the UK.

CO

IVD-registered in Colombia.

CR

IVD-registered in Costa Rica.

IL

IVD-registered in Israel.