Geisinger Medical Laboratories/Geisinger Proven Diagnostics Test Catalog

Order Display Name: Geisinger Epic Procedure Code Or ID CPT Code:  

LUNG CANCER (NSCLC) ROS1 (6Q22) REARRANGEMENT,FISH

ORDERING INFORMATION:
Geisinger Epic Procedure Code: LAB1021         Geisinger Epic ID: 52009

SPECIMEN COLLECTION
Specimen type:
Lung tissue biopsy in formalin-fixed paraffin-embedded tissue block OR 5x5 mm tumor tissue in culture transport medium. 4-5 microns section on charged slide (x5)
Preferred collection container:
Paraffin-embedded block
Alternate Collection Container:
Tissue culture transport media
Glass Slides
Specimen required:
Preferred: Lung tissue biopsy in formalin-fixed paraffin-embedded tissue block. Alternative Specimens: 5x5 mm tumor tissue in culture transport medium. 4-5 microns sections on charged slide (x5)
Special notes:
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.

SPECIMEN PROCESSING
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.

TEST DETAILS
Additional information:
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.
CPT code(s):
88271x2, 88274
Note: The billing party has sole responsibility for CPT coding.  Any questions regarding coding should be directed to the payer being billed.  The CPT codes provided by GML are based on AMA guidelines and are for informational purposes only.
Test includes:
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.
Methodology:
Fluorescence In Situ Hybridization (FISH)
Synonyms:
Crizotinib, FISH, Lung Cancer (NSCLC),Non-Small Cell Lung Cancer (NSCLC),Xalkori®,ROS1 (6q22) Rearrangement, Quest test code 91836, FISH ROS1
Clinical significance:
Lung Cancer (NSCLC), ROS1 (6q22) Rearrangement, FISH - 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)

Performing Locations

Quest Diagnostics

Technical Lead: Michael Weaver    
Frequency: Set up: Daily; Report available: 7 days    
Performed stat? No
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