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API2(BIRC3)/MALT1 t(11;18)*, paraffin

Test ID: FP API MALT1* CPT Code: 88377
Expected Turnaround Time
9 days
Stated turn-around-times (TATs) are for clinical use only and subject to change based on biopharma protocol requirements. Final TATs will be specified in the biopharma study contract.
Clinical Information
FISH testing on paraffin-embedded cells for detection of API2::MALT1 gene fusion. This fusion, associated with t(11;18), is frequently observed in MALT lymphomas (also known as extranodal marginal zone B-cell lymphoma of mucosa-associated lymphoid tissue) constitute about 8% of all non-Hodgkin lymphomas. The most common structural abnormality associated with MALT lymphomas is the translocation between API2 and MALT1. *Testing performed by affiliate laboratory.

Specimen Requirements

Specimen Requirements
  • FFPE Tissue Block
  • Unstained FFPE tissue: 5 slides preferred (3 slides minimum) cut at 3-5 μM and mounted on positively charged slides. 
Specimen Stability

Stable indefinitely

Storage Requirements

15°C to 25°C

Shipping Conditions
Ambient
Shipping Recommendations

AMBIENT, Use a refrigerated (NOT FROZEN) gel pack in the shipment to protect from extreme temperatures. Separate gel pack from specimen. Do not freeze.

Specimen Rejection Criteria

Improper fixative; Tissue not fixed; Insufficient tissue; Specimen exposed to extreme temperature

Test Details

Synonyms

t(11;18)(q22;q21), MALT lymphoma, Mucosa associated lymphoid tissue translocation gene 1, API2, MIHC, RNF49, MLT

Keywords
Fluorescence in-situ Hybridization, Oncology, Oncology FISH Probes, Lymphoma
Test Method
Fluorescence in situ hybridization (FISH)
Methodology Category
FISH
Regulatory Status
ASR
Special Considerations

Tissues should be fixed in 10% neutral buffered formalin (NBF). Tissues preserved in B+ fixative or decalcified are usually not suitable for FISH. Assay requires 3 unstained slides minimum (two for each probe) and one H&E stained slide. If unstained slides are sent, cut FFPE tissue sections at 3-5 μm thickness, mounted on positively charged slides. 

Associations

MALT lymphoma, Non-Hodgkin (NHL), Extranodal marginal zone B-cell lymphoma