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| A B C D E F G H I J K L M N O P Q R S T U V W X Y Z # |
Lung Cancer (NSCLC), ROS1 (6q22) Rearrangement, FISH
Test Code91836
CPT Codes
88271 (x2), 88274
Preferred Specimen
Lung tissue biopsy in formalin-fixed paraffin-embedded tissue block
Other Acceptable Specimens
5x5 mm tumor tissue in culture transport medium • 4-5 microns sections on charged slide (x5)
Instructions
Lung tissue biopsy, formalin-fixed, paraffin-embedded block or charged/+ slides from formalin fixed paraffin embedded tissue. Specimen MUST be fixed in 10% neutral buffered formalin. Fixation between 6 and 48 hours is recommended.
Pathology report must accompany paraffin block or slides. Information required in this report include: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis. Ship at room temperature. Do not freeze. Do not reject.
Note: Test performed: 100-300 interphase cells are microscopically analyzed for probe signal patterns indicating rearrangement of ROS1 located at 6q22.
If results are not possible, the test order may be canceled and replaced with a Cytogenetics Communication.
Pathology report must accompany paraffin block or slides. Information required in this report include: Physician identification, specimen identifiers (case and block number), specimen site and type, tissue processing used (routine or microwave), type of fixative, time and duration of fixation, pathologic diagnosis. Ship at room temperature. Do not freeze. Do not reject.
Note: Test performed: 100-300 interphase cells are microscopically analyzed for probe signal patterns indicating rearrangement of ROS1 located at 6q22.
If results are not possible, the test order may be canceled and replaced with a Cytogenetics Communication.
Transport Temperature
Room temperature
Specimen Stability
Specimen viability decreases during transit. Send specimen to testing lab for viability determination. Do not freeze. Do not reject.
Methodology
Fluorescence in situ Hybridization (FISH)
FDA Status
This test was developed and its analytical performance characteristics have been determined by Quest Diagnostics. It has not been cleared or approved by the U.S. Food and Drug Administration. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.
Setup Schedule
Set up: Daily; Report available: 7 days
Reference Range
See Laboratory Report
Clinical Significance
ROS1 rearrangement has been identified in 1.7% of non small-cell lung cancer (NSCLC) by using a FISH assay. Treatment with ALK/MET tyrosine kinase inhibitors such as crizotinib (Xalkori(R)) has shown early evidence of therapeutic efficacy in ROS1-rearranged NSCLC (Bergethon, et al. J Clin Oncol. 2012;30:863-870)
