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ROS1 6q22.1 Rearrangement, paraffin

Test ID: FP ROS1 CPT Code: 88377

Expected Turnaround Time
5 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 ROS1 (6q22.1) gene rearrangement. ROS1 rearrangements occur in a subset of non-small cell lung cancers (NSCLCs) and, less frequently, in glioma. Often ordered with FP ALK.

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

6q22.1 rearrangement; Receptor Tyrosine Kinase (RTK); Non-small cell lung cancer


Keywords
Pathology, Fluorescence in-situ Hybridization, Molecular Diagnostics, Oncology, Oncology FISH Probes, Mutation Analysis, Bladder Cancer, Lung Cancer

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

Lung cancer